New era at the NIH

US medical researchers brace themselves for budget cuts

In 2006, the National Institutes of Health (NIH), guided by the leadership of Elias Zerhouni, launched the Clinical and Translational Science Award (CTSA) program to jump-start transformative change in the nation’s research agenda to emphasize translating discovery from the bench to implementation in the community.1-5 Much of the funding for the CTSAs was garnered by rolling NIH funding of General Clinical Research Centers and educational K and T awards. Successful applicants were then asked to utilize these funds to (as stated in the Request for Applications) “transform the local, regional and national environments for clinical and translational science and to increase the safety, efficiency and speed of clinical and translational research.”4 Each of the 60 CTSA institutions has approached addressing this transformation in slightly different ways; however, it has become clear over the last 5 years that substantive changes, as a result of CTSA funding at academic institutions, are transforming medical research and the infrastructure that supports it. Each of the CTSA’s is required to address specific key functions to advance the consortium goals. These required key functions are (1) expertise in Biomedical Informatics, (2) a program in Research Education, Training, and Career Development, (3) a program in Community Engagement and Research, (4) an Evaluation component, (5) Pilot Projects in Translational and Clinical Studies, and (6) a Regulatory Knowledge and Support component. Optional CTSA key functions include (1) support of the Development of Novel Clinical and Translational Methodologies, (2) components or cores to support Research Design, Epidemiology, Biostatistics, and Clinical Research Ethics, (3) Clinical Research Resources and Facilities, and (4) components or cores that develop Translational Technologies and Resources. It is also encouraged for institutions to support research in Child Health. Addressing these key functions at the University of Michigan, for example, has led to transformational change in the structure and culture of the institution. After receiving a CTSA award in 2007, the University of Michigan (U-M) conducted a strategic assessment of the translational research enterprise through over 100 extensive interviews of faculty and staff providing the infrastructure for translational research, as well as the investigators conducting that research. The institution then conducted a survey of research team members involved in human subject research to identify and describe the current challenges facing translational research—specifically, the administrative processes associated with its planning and execution. In addition to identifying the issues, the team rated the technical and cultural/political levels of difficulty in implementing the solutions, as well as the corresponding impact each solution would potentially bring. These were then graphically mapped on a three-dimensional bubble chart (Figure 1). This stratification assisted in the planning, design, and prioritization of solutions, offering insights that guide the refinement efforts of a clinical research enterprise’s organization, business, and information technology (IT) processes. Bubble chart of implementation complexity. The chart orders tasks by level of execution difficulty—both technical and fiscal execution difficulty—as well as organizational and cultural complexity. The bubble size represents impact such that the bigger the bubble, the bigger the impact the change will have on improving translational research. For instance, enhancing study coordinator programs is relatively easy both technically and from an institutional buy-in perspective and was judged to provide a relatively large impact. Creating integrated informational technology systems involves significant investment, is more technically complex, requiring buy-in from multiple parties within the institution but is pivotal for achieving the goal of doing more effective translational research. The visual mapping provides context and definition to the challenge of enhancing the efficiency and effectiveness of translational research not only at the University of Michigan but all of the CTSAs. IT = Information Technology, CTSU = Clinical Trials Support Unit. Eight areas were identified as solution categories. The topics include organizational, procedural, financial, structural, educational, technological, and cultural elements. Transform and expedite study and contract approval process. The contract approval process, especially in regard to industry protocols, was recognized by the faculty as their number one area of discontent. The approval process was not clear to research team members and varied widely by unit and department as well as by type of sponsor. Educational and process improvement opportunities were identified. To address these issues, U-M has set a goal to expedite study approval process so that the contract and regulatory processes are executed within 60 days from submission for all studies and 45 days for industry-sponsored studies. The primary strategy to accomplish this aggressive goal was to create a team consisting of members of the units involved and to reengineer processes and conduct a demonstration project for feasibility within 1 year. Secondary strategies included increasing the transparency of contracting within the system to allow better tracking of proposals by the faculty and study teams, publishing desirable contract terms on a website for faculty and staff to use as protocols are developed, and to create an interactive, web-based research road map to guide faculty and staff through the necessary administrative steps to conduct translational research.6 Establish a clinical research support unit with best practice tools. The current translational research enterprise consists of multiple units with redundant functions of varying quality. The primary strategy was to create a leveraging of the resources of the CTSA to develop a franchisable model built on best practice modules that could then be easily adopted by other units throughout the university. Develop a customer friendly, transparent financial system that spans clinical trial budget creation to account reconciliation and study close out. The lack of transparent and integrated financial systems to track costs and other financial aspects of clinical research including budgeting and billing remains a challenge for study team members. The University of Michigan Office of Research has created the Calendar Review and Analysis Office (CRAO) to assist researchers with this process and is currently implementing a clinical study budget tool, eThority, to create standard billing calenders and processes across the organization. CRAO will also champion the evaluation of financial feasibility prior to proposal initiation; provide more assistance to PIs and research team members with study budgets, through increased training on best practices, budget negotiators, and standardized internal budget; and generate a new reconciliation report that will make study account statements more easily understood by research teams. Improve regulatory approval process and reduce Institutional Review Board (IRB) turn-around time. Significant gains have been made, resulting in a 40% improvement in IRB cycle time. Study teams will be advantaged by continuous improvements to the process. Embedded within the goal to expedite study approval is the goal to reduce IRB turnaround time (TAT) to 21 days for full convened board approval, including ancillary committees, and reduce no more than minimal risk studies to 5 days TAT. U-M is investigating strategies for greater IRB board participation of faculty, instituting another IRB board specifically for industry-based studies, as well as dedicating a board to minimal risk studies. The CTSA is also identifying various research teams to extract best practices. The CTSA has created an IND/IDE consultation and support team for researchers that have already helped over 100 investigators with IND/IDE applications. Create a home for study coordinators to promote education and sharing of best practices. A strong research team, anchored by a solid study coordinator, is critical to clinical research success. Study coordinator turnover was noted to be 18% a year. Of all study coordinators, 75% have been at U-M less than 3 years, compared to 44% of the rest of U-M staff and 56% of study coordinators nationally. Study coordinators noted that there was no coherent program or “home” for them within the system. Several strategies have been developed and are being enacted to address this problem. The CTSA created a virtual, web-based site for study coordinator support that will eventually include standardized resources such as workflow steps, templates, forms, and answers to common questions. A monthly study coordinator forum has been enacted to share challenges and best practices. Human resources has been engaged to develop uniform study coordinator job descriptions and to mentor the coordinators to develop a meaningful career path. Increase patient participation (enrollment) in research. The institution has set an ambitious goal to double patient participation in research in 5 years, while decreasing the number of studies that do not enroll a subject to 5%. A primary strategy to accomplish this was the creation of a web-based participant registry (UMclinicalstudies.org) to help match interested patients and volunteers with open studies. Currently, over 7,000 participants are registered. U-M is also investing in an electronic medical record system that better enables queries and “flags” potentially eligible patients. Further investigation by a study team is necessary to determine the underlying reasons for poor accrual to studies, whether due to missed competitive enrollment periods, rare disease studies that inherently will be challenged to accrue, registry studies with open enrollment, lack of ability to find enough patients within the patient population, or unwillingness to ask patients to participate. Understanding and addressing the underlying issues provides an opportunity for the CTSA to improve the quality, and potentially reduce “waste,” in the proposal and regulatory systems. Achieve efficiencies through integration of multiple, fragmented IT systems. More than 30 IT systems, as well as paper records, were identified that are currently utilized by investigators to perform clinical and translational research. Moreover, multiple IT service providers exist across the institution with poorly defined roles, responsibilities, and accountability. Alignment of key IT systems and personnel that support clinical and translational research is imperative. The CTSA is playing a central role in developing and leading a cohesive strategy that integrates IT for researchers’ benefits. For example, the institution is investing in a system-wide approach to develop an overall architecture that will create a clinical data repository. Evolve the culture of U-M to be more supportive and enthusiastic of clinical research. Like many academic institutions, the University of Michigan has struggled to value clinical research to the same extent as the basic sciences. In interviews and surveys, many faculty noted that choosing a career in clinical research can be seen as “falling between the cracks” or not as respected as a career in basic research. While improving infrastructure demonstrates value to these researchers, it is not enough. The CTSA has advocated to create a working group to make recommendations to University leadership to increase recognition for excellence in clinical research, to refine promotion and incentive criteria to value scholarly clinical activity and emphasize collaboration and innovation across all disciplines (team science). Furthermore, a plan is being developed to expand training programs to support training of those who want to become clinical and translational researchers, beyond the few slots that the CTSA (K and T programs) can currently support. The mission of the CTSA to enhance an investigator’s ability to conduct translational research at the University of Michigan has resulted in concrete organizational plans and investments to improve infrastructure of translational research and increase the satisfaction of participants, faculty, and staff who are engaged in these activities.7 Similar changes are occurring at CTSA institutions all over the country, validating the vision of Dr. Zerhouni and the investment in these vehicles of change by the NIH. Supported by UL 1RR024986 NIH/NCRR—Clinical and Translation Science Award.

Task Force 8: Pediatric Cardiology Fellowship Training in Research and Scholarly Activity. SPCTPD/ACC/AAP/AHA.

OBJECTIVES/SPECIFIC AIMS: A growing concern about the declining physician-scientist workforce prompted the 2014 National Institutes of Health (NIH) Physician Scientist Workforce to recommended that “tools for assessing the strength of the biomedical workforce” be developed. To aid strategic planning, the Oregon Clinical and Translational Research Institute convened key stakeholders at its home university, Oregon Health and Science University (OHSU), to survey the local landscape of physician scientists. Surprisingly, few consensus methods were available to measure and benchmark OHSU with respect to national comparators. To address this deficit, we sought to develop clear and objective metrics describing physician-scientist success at our institution. By focusing on local funding, we were able to generate more complete and robust data than others have reported. These data also permit us to compare ourselves to the national workforce, using well-curated and accessible national databases. The goal of the analyses is to contribute to strategic decision-making by portraying the local physician-scientist workforce, comparing it to the national landscape, and making recommendations about mechanisms to address potential opportunities. This has led us to develop a simple quantitative dashboard, which now permits OHSU to craft strategic targets and address successes and opportunities. These approaches are likely to be valuable elsewhere. METHODS/STUDY POPULATION: OHSU is a medium-sized academic health center in Portland, Oregon with over 1200 principal investigators and over $230M in NIH funding. The primary focus of our investigation was physician-scientists who receive extramural funding. To align with other analyses, we distinguish physician-scientists with an M.D. only, or with an M.D. and a master’s degree, from physician-scientists who hold an M.D./Ph.D. For this distinction, we use the indicator “M.D.-only” to indicate the former. The study design consisted of (a) selection of available and relevant national level data on the physician-scientist workforce, (b) curating of local level data to align it with the national indicators, (c) comparing the 2 sets of data to look for differences in trends over time, and (d) supplementing the analyses with additional local data not available at the national level. Key comparisons were tested for statistical significance and plotted on a dashboard, which was then reviewed by an OHSU internal working group focused on physician-scientists. Data elements included degrees, age, gender, and grants awarded. National data come directly from the NIH Data Book, updated for fiscal year 2016. The NIH makes all funded project data available in the publicly downloadable ExPORTER Data Catalog. These project data were used to supplement the summarized data available from the NIH Data Book, allowing us to extract OHSU investigators and to complete the K to R comparative analysis. For analyses of OHSU investigators holding funding other than RPGs, we relied on institutional data from the OHSU grants and contracts office. Demographic data on OHSU investigators were obtained from departmental and human resource records. The time period for these analyses was 1998–2016. RESULTS/ANTICIPATED RESULTS: At OHSU, as nationally, there has been an increase in RPG-holding Ph.D.s but not in RPG-holding physician-scientists. At OHSU, nearly three-fourth of physician-scientist RPGs hold an M.D.-only degree, compared with nationally, where nearly half of physician-scientists are M.D./Ph.D.s. The percent of younger, early-career, RPG-holding physician-scientists has declined precipitously at OHSU and nationally. At OHSU, the percentage of RPGs held by women physician-scientists is below the national figure. Funding sources for physician-scientists at OHSU were more diverse than for Ph.D. scientists, and physician-scientists comprise the majority of Principal Investigators on clinical trials. These non-RPG sources of funding remain a critical source of support, although local analyses of time spent on research indicate that physician-scientists with NIH funding spend a greater percentage of their time on research than those without. OHSU PI’s have had success in transitioning from K08 and K23 grants to R-level grants, with similar percentages receiving RPGs within 5 years. A dashboard comparing these trends was developed. DISCUSSION/SIGNIFICANCE OF IMPACT: There were 3 key impacts from our analyses. First, we developed and disseminated a dashboard with both local data and national comparators. Second, in consultation with institutional leadership, we selected target values to define success for each metric. Third, we recommended actions that will help OHSU meet the selected targets. A major accomplishment of this structured approach has been the identification of opportunities for change that were not recognized previously. For example, leadership was not aware of the substantial and growing deficit in female physician-scientists at OHSU, compared with the impressive increases nationally. Thus, to reduce gender disparity at OHSU, we have recommended purposeful recruitment; one approach is to target female graduates of Medical Scientist Training Programs for faculty positions, as this group has better success at achieving R-level funding than do M.D.-only applicants. Another outcome is to help set ambitious but reasonable targets for improving the local landscape. Thus, we aim to reduce the average age of RGP-holding physician-scientists at OHSU by one year during the next 5 years. Although reversing current trends will not be easy, our analyses suggest that the average age of RPG level physician-scientists at OHSU would decrease were OHSU were to match the national-level proportions of women and M.D./Ph.D. physician-scientists. In addition to targeting gender disparities, we have recently implemented a program that supplements funding for recruiting young physician scientists, and then supporting their pursuit of RPG funding. Locally, a bright spot is the K to RPG transition rate for K23 awardees, which compare favorably with national data, an outcome that we plan to maintain. In analyzing this area of success, one reason is our strong mentorship program, called OCTRI Scholars, which is provided through our CTSA-sponsored institute. This has fostered an atmosphere of success among young physician-scientists and is one of the reasons that we endorse recommendation #9 from the PSWR, suggesting that Clinical and Translational Science Award (CTSA) Institutes play pivotal roles in monitoring and enhancing the success of the physician-scientist workforce. Thus, several perceived deficiencies might be addressed with adjustment of 1 or 2 specific institutional policies. While the specific opportunities and strengths may be different at other institutions, our proposed dashboard, which couples publicly curated, freely accessible databases, with readily available institutional resources, should help institutions to set and achieve their own goals.

Translational research in the decade of discovery

SCTS was established in 2008 with the mission of advancing research and education in CTS so as to improve human health. Since CTS research is a cross-cutting enterprise, SCTS will focus on the multidisciplinary processes of conducting CTS research rather than on the results in any specific scientific area or disease. As the missions of many different professional societies overlap SCTS's mission and SCTS recognizes and respects the contributions that these societies have made in advancing the discipline of CTS, SCTS is eager to join with these societies in the common cause of advancing the field. By serving as the bridge between scientific discoveries and improved diagnosis, therapy, and prevention of human disease, CTS research differs from basic science discovery, which focuses on the generation of new knowledge without regard to its immediate application to medicine. The primary objective of CTS research is the improvement of human health at both the individual and community levels. Viewed from an economic perspective, CTS research is also essential for the success of the pharmaceutical, biotechnology, and medical device industries, facilitating the conversion of scientif c discoveries into new drugs and devices, and creating new jobs that derive from the manufacture, sales, and distribution of the drugs and devices. CTS research also has a role in national defense, including the development of methods to diagnose and treat diseases caused by biologic weapons. Thus, CTS is essential for achieving many of the goals the public expects from its investment in medical research through support of the National Institutes of Health (NIH). The creation by the NIH of the Clinical and Translational Science Award (CTSA) program in 2006 dramatically heightened awareness of the discipline of CTS in academic institutions, industry, and philanthropy, as well as among the broader public and the policy makers at local, state, and national levels. With its focus on developing and augmenting advanced degree-granting training programs in CTS, many of which built on the excellent curricula developed under the aegis of the NIH Clinical Research Curriculum K30 Award program, the CTSA program also provided encouragement and new resources to create imaginative educational experiences for individuals who seek careers in CTS. Based on 2007 data from the CTSAs, there are already more that 500 trainees in these programs and when the CTSA program reaches its stated goal of 60 centers, it is likely that there will be more than 1,000 trainees in these programs at any time. The past several decades have been marked by astounding advances in basic science, epitomized by the success of the human genome project and the growing “-omics” revolution. This explosion of knowledge has not, however, been matched by a comparable increase in the translation of that knowledge into new therapies. In fact, the number of truly novel drugs and biologics approved by the Food and Drug Administration each year has not substantially increased since the 1970s despite more than a 10-fold increase in inflation-adjusted investments by the pharmaceutical and biotechnology industries. While many factors Society for Clinical and Translational Science (SCTS) Governance Barry Coller (Rockefeller University) – President Harry Selker (Tufts Medical Center) – Vice President Rebecca Jackson (Ohio State University) – Secretary Anantha Shekhar (Indiana University) – Treasurer Board of Directors Robert Califf (Duke University) Marc Drezner (University of Wisconsin) Daniel Ford (Johns Hopkins University) David Guzick (University of Rochester) Gary Hunninghake (University of Iowa) Eric Orwoll (Oregon Health & Science University) Kenneth Polonsky (Washington University) Robert Sherwin (Yale School of Medicine) NIH Liaison to the Board of Directors John Gallin (NIH Clinical Center) Standing Committees Henry Ginsberg (Columbia University) – Annual Meeting Paul Marantz (Albert Einstein College of Medicine) – Annual Meeting John Gallin (NIH Clinical Center) – Membership Kenneth Polonsky (Washington University) – Nominations Philip Greenland (Northwestern University) – Publications Harry Selker (Tufts Medical Center) – Public Education & Governmental Affairs Anantha Shekhar (Indiana University) – Finance & Audit have contributed to this disappointing gap between scientifc opportunity and medical advance, one important factor is the increasing complexity of conducting CTS research. The full expression of CTS research requires the convergence of expertise across 3 dimensions. The first dimension is the multidisciplinary approach required to perform studies involving human participants. In the past a single investigator could examine a patient on the ward in the morning, take a sample back to the lab and perform an assay by midday, then return to the ward in the af ernoon and institute a novel therapy based on the experimental results. Today, such research requires the efforts of clinical research coordinators, research nurses, pharmacologists, research pharmacists, biostatisticians, bionutritionists, and clinical monitors and auditors, as a well as experts in the protection of human subjects, recruitment, community engagement, bioinformatics, and information technology. The laboratory evaluation itself requires a team approach, with a focus on advanced and expensive instrumentation and procedures commonly found only in large core facilities, supported by extensive quality control programs that meet the exacting standards for clinical laboratories. The second dimension is the continuum that extends from defining a health need, often via careful analysis of epidemiologic data, through basic investigation, preclinical evaluation, human studies, small and large scale clinical trials, analysis of clinical adoption and both therapeutic- and cost-effectiveness in the community, and, finally, returning to epidemiology. This dimension is composed of multiple bidirectional cycles, since each component contains information that potentially can advance every other component. As a result, the free flow of information across what are increasingly viewed as arbitrary boundaries is crucial for success. For example, the data from the Framingham Heart Study demonstrating the association between the risk of vascular disease and serum cholesterol levels played an important role in encouraging investigation of cholesterol metabolism at the molecular level, laying the groundwork for the development of drugs to reduce serum cholesterol levels. The third dimension links the academic community with its partners in the CTS enterprise, including granting, public health, and regulatory agencies; policy makers; the pharmaceutical, biotechnology, and medical device industries; and the philanthropic organizations that fund and support research. Most importantly, using the stem cell analogy, it is essential that the discipline of CTS has the capacity for self-renewal. A commitment to the training and mentoring of the next generation of investigative teams, as well as the support and recognition of the mentors who play the most important role in both training and career development, is crucial for the success and long-term stability of the enterprise. Fortunately, the Association for Clinical Research Training (ACRT) and the National CTSA Consortium Education and Career Development Key Function Committee recognize this need and have jointly conducted an outstanding meeting for trainees and mentors for the past several years. Become a Member For more information visit the SCTS Web site, http://www.societycts.org, or e-mail SCTS@smithbucklin.com. Based on the foregoing considerations, the immediate goal of SCTS is to conduct an annual meeting in cooperation with ACRT and the CTSA Education and Career Development Committee. The first annual meeting is scheduled for April 5-7, 2010, in Washington, DC. It is open to all individuals who participate in or support CTS in academic institutions around the world, as well as individuals from industry, government, and philanthropy. The meeting will focus on the needs of trainees and junior faculty; provide a forum for dissemination of new developments in the design and conduct of CTS research; provide a forum for leaders in governmental agencies, the private sector, and philanthropic organizations to provide updates on their programs related to CTS research; and facilitate scientific collaborations and the development of a cultural identity for the discipline through opportunities for social networking. Other societies with overlapping missions are encouraged to consider meeting in the same location and time as SCTS. SCTS was initially founded by all of the then 38 CTSA recipient institutions as well as the NIH Clinical Center. Since that time the list of founding institutions has extended beyond the CTSA program (an updated list is posted at http://www.societycts.org) and additional institutions are invited to join the list of founding institutions, which will remain open until the f rst SCTS annual meeting. To add your institution to the list of founding institutions, contact the SCTS administrator at (202) 367-1119. Governance is vested in a Board of Directors and of cers derived from institutional members and a liaison member from ACRT. The current Board of Directors, of cers, and committee chairs are listed in Table 1. CTS has been designated as an official journal of SCTS. SCTS wishes to express its deep appreciation to Arthur Feldman, MD, PhD, CTS editor-in-chief, and Danette Somers of Wiley-Blackwell for their support in establishing this relationship. As the founding president of SCTS I want to thank all of the individuals who have worked hard to convert the idea for SCTS into the reality of a newborn society, learning and adapting as it begins its journey, but filled with the excitement, enthusiasm, and expectations that uniquely mark a true new beginning. I look forward to working with each of you to make certain that SCTS achieves its remarkable potential.

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The Policy Forum by Leon E. Rosenberg ( Science 's Compass, 15 Jan. p. [331][1]) and letters from William R. Brinkley and Ajit Varki ( Science 's Compass, 5 Feb. p. 791) concerning the decline of physician-scientists and their research are commendable. However, a subtle but critical point, which has a major impact on the situation, has not been mentioned. The problem stems from the all-inclusive classification by Rosenberg of physician-scientists as those performing “basic, disease-oriented, patient-oriented, population-oriented, and prevention-oriented” investigation. Upon careful analysis of the data and consideration of the kinds of research being performed by the extremely diverse group of M.D.'s and M.D./Ph.D.'s, it is clear that the problem for prototypical physician-scientists (that is, those performing laboratory-based, disease-oriented research) is much more precarious than appreciated. ![Figure][2] Can the classical physician-scientist survive?CREDIT: VISUALS UNLIMITED M.D.'s performing typical clinical research and those doing pure basic science who do not see patients are in fact comparatively well off and therefore should not be included in the discussion. Rather, the critical decline in M.D.'s performing research has been limited largely to traditional physician-scientists, those performing laboratory-based investigation who extend into the clinical arena. The immediate future for this group is clouded by the almost complete exhaustion of M.D.'s who desire this classical career pathway. Evidence for this comes from the trend in M.D.-focused National Institutes of Health (NIH) training grants. Although many of these slots are still being filled by M.D.'s (and this looks fine to NIH), most training programs have refocused their objectives to train clinical researchers. Therefore, these training grants are being filled by M.D.'s who will perform pure clinical research; indeed, in 1999, the emphasis on M.D. research has shifted squarely to evidence-based medicine/outcomes research. Furthermore, given the influence of managed care, the palpable emphasis now being placed on this type of clinical research in medical schools, and the new K23 and K24 awards (which have been designated for clinical researchers to the exclusion of laboratory-based M.D.'s), M.D.-driven clinical research is almost certainly assured of future success. This is not the case for laboratory-based M.D.'s. The depletion of these physician-scientists is only beginning, and the problem is going to be amplified dramatically in the next few years. The critical question is whether it is too late. It very well may be. If there is any hope, however, then the steps highlighted by Rosenberg, Brinkley, Varki, and others must be endorsed by the entire medical community and acted upon immediately. # {#article-title-2} Like many clinicians, I have identified common problems that are easily definable, but not easily treatable. I would like to have the opportunity to research some of these issues, but do not have the time as a full-time clinician. When I have discussed this with my boss, he has told me if I could produce some promising data, he would give me protected time to develop them. However, I can't get protected time to get the initial data with my busy clinical schedule. Thus, I am in a “Catch- 22.” If I get the data, I can get protected time. Yet, without the protected time, it will be very difficult to get the data. Despite these obstacles, I am trying to pull some of the early pieces together in my “off hours.” This is difficult and may ultimately not be fruitful. I would love the opportunity to be able to apply for a starter program for mid-career clinicians who would like to research a clinical issue. I believe that I have insights into disease processes that are worth exploring. Yet, they will remain at the level of a hypothesis or an anecdote unless I am able to have the time to systematically develop an approach to study them. # {#article-title-3} Unmentioned in Rosenberg's Policy Forum are the significant disadvantages for a physician-scientist being funded by NIH. For example, a physician-scientist earning $150,000 per year who receives NIH funding for 50% of time and effort would have a shortfall of $15,375, assuming a fringe benefit rate of 23%. He or she must cover malpractice insurance; support the training of medical students, residents, and fellows; and support the clinic operations. These expenses easily reach $60,000 per year; none is covered by NIH grants, and the physician-scientist is held responsible. If one assumes that the physician-scientist can meet his or her financial obligations by a 47-hour work week seeing patients, he or she would have to work an additional 7.8 hours a week to make up the shortfall. Even being paid the NIH salary cap, he or she would still have to work an additional 5.3 hours a week to meet the uncovered costs. Most physician-scientists put in these hours, but is it any wonder that medical students would be leery of pursuing a career in research? One could argue that these additional expenses should be covered by the clinical department or by indirect costs. However, there are numerous reasons why this is unlikely to occur. Further, the physician-scientist would have to go “hat in hand” in order to get special consideration. One realistic solution is for NIH and other funding agencies to recognize the special and extra costs associated with a physician-scientist's work. These funding agencies should grant to the individual physician-scientist the necessary funds to cover these expenses in order to ensure that those funds directly support the physician-scientist doing the research. Otherwise, not only will we see fewer physicians entering research; we will see more physicians leaving. # {#article-title-4} Not that many years ago, a department in a medical school which provided clinical care could obtain enough money through its revenues generated by patient care reimbursement to underwrite a meaningful portion of the faculty effort required to do clinical research. While one might argue that such reimbursement was not intended for this purpose, it was a practice understood and accepted by all involved, and the money spent for these research efforts by and large was a good investment for the country in general. The cost-cutting efforts that have affected all of medicine, including but not restricted to managed care and HMOs (health maintenance organizations), are in the process of rapidly eliminating this subsidy to clinical science. I do not know the amount of money this represented, but it certainly ran to many millions—perhaps hundreds of millons—of dollars. Its loss will be strongly felt, not just by the physician-scientists whose efforts would have been supported in this way, but also by the many hundreds of thousands of patients who would have benefited. Not only are changes in health care delivery practices making it extremely difficult to recruit patients into clinical studies, but paying for the time that is needed to complete these studies is becoming increasingly problematic. Any endeavor to prevent the extinction of this species of scientist will need to address these issues. [1]: /lookup/doi/10.1126/science.283.5400.331 [2]: pending:yes

In <i>the</i> NEWS: A ROUNDUP OF NEWS AND INFORMATION FROM OUR COMMUNITY

The American Association for Cancer Research (AACR) is the first and largest cancer research organization dedicated to accelerating the conquest of cancer. The stated purpose of the organization when it was founded 115 years ago was “to further the investigation and spread the knowledge of cancer.” Since that time, the AACR has been the driving force to eradicate cancer. Publication of research findings has always been critical to this endeavor, with the 11 founders recognizing the importance of “sharing observations” and the need for a journal to “collect under one cover such contributions as bear in any way upon the general problems of oncology.”The AACR launched its first peer-reviewed scientific journal, The Journal of Cancer Research, in 1916. At the time, it was the only English-language cancer journal in the world. Since then, the AACR portfolio of journals has grown to 10. These journals cover the full spectrum of cancer science and medicine and together, over the years, have published over 100,000 articles and over 130,000 meeting abstracts. This is an immense contribution to the body of knowledge on cancer and has ignited communication among cancer scientists and physicians, helping to catalyze a revolution in the field.We are honored to serve as the current Editors-in-Chief of the AACR journals. Each of the 10 journals was launched by the AACR to meet the scientific information needs of its membership and all those engaged in cancer research. Under our leadership, the journals engage closely and collaboratively with the community to facilitate the presentation and wide dissemination of research findings. Importantly, the AACR is a not-for-profit publisher. This means that any surplus from the AACR journals program is used to help support the cancer research community and the mission of the AACR to prevent and cure all cancers by contributing to funding for AACR grants, scientific conferences, and science policy and advocacy efforts. Here, we highlight the unique roles of our journals within the family of AACR journals and how they serve to advance the mission of the AACR.At the inception of the AACR, there was a clear need for journals focused on cancer research to assemble key studies to help guide the field. Cancer Research was launched in 1941 as the flagship journal of the AACR from a rich ancestry that started with its predecessors: The Journal of Cancer Research (1916–1930) and The American Journal of Cancer Research (1931–1940). From the very beginning, Cancer Research has published landmark papers (https://aacrjournals.org/cancerres/pages/landmark_articles) that have enriched our knowledge of cancer biology and treatment and have provided the foundation upon which major breakthroughs have been built. In the first year of publication, Cancer Research featured seminal studies on the effect of castration on prostate cancer and the mechanism of carcinogenesis that shaped the field (https://www.aacr.org/wp-content/uploads/2019/11/CancerResearch_75Anniversary_1941-2016.pdf). Cancer Research has continued to publish articles that cover the full range of research, spanning from investigations on drug discovery, cancer molecular mechanisms, and the tumor microenvironment to clinical and population studies. As cancer research has evolved over the past century, new AACR journals have emerged to embrace and support expanding fields, providing specialized venues for studies that deepen our understanding of areas that were historically covered by Cancer Research. In this regard, the “pedigree” of AACR journals stemmed from the principles set by Cancer Research, which remains a venue for publishing fundamental studies in all areas of cancer research, including emerging areas such as cancer data science and mathematics. As a society journal, Cancer Research serves the community through its editorial process that is guided by the judgment of international academic editors who provide rich expertise in various areas as practicing researchers. Further, the Journal embraces early career investigators and has recognized these researchers with the prestigious Cancer Research Early Career Award. Guided by its extensive history, Cancer Research hopes to motivate and support the next generation of scientists to lessen the burden of cancer through their innovative research.As cancer science and medicine entered the molecular biology era, it became clear that a communication channel was needed to emphasize basic science studies in oncology—studies that report significant mechanistic findings at the molecular or cellular level. Originally published under the title Cell Growth & Differentiation from 1990 to 2002, Molecular Cancer Research (MCR) was launched as the AACR was beginning to build its now-renowned focus on molecular biology and genetics. The Journal served to help emphasize this focus and attract more scientists into the AACR's membership. As part of this mission, MCR features studies exploring the molecular underpinnings of each of the hallmarks of cancer, with a particular emphasis on studies elucidating oncogenic alterations in metabolism. Cancer metabolism is increasingly recognized as a key vulnerability of tumor biology. MCR is committed to recruiting and disseminating studies featuring novel metabolomic analyses, mass spectrometry, metabolic imaging and tracing, and other approaches that clarify links between metabolism and cancer, with the goal of identifying metabolic vulnerabilities and adding to the armamentarium of anticancer interventions. In addition to publishing impactful basic cancer research studies, the Journal aims to promote diversity of thought and perspective within the basic cancer research community. To achieve this goal, MCR has launched an initiative in which senior investigators are paired with rising stars in their fields to write and edit review articles jointly. This initiative encourages collaboration among researchers by integrating historical perspectives with new directions to provide novel, actionable insights for the field.Cancer Epidemiology, Biomarkers & Prevention (CEBP) is the leading subspecialty journal for fundamental and applied population science research describing the burden of cancer; uncovering possible causes of cancer and its progression; and informing and evaluating strategies for cancer prevention, early detection, cancer survivorship, and closing the cancer disparities gap. CEBP is unique among AACR journals in focusing on populations at risk for cancer, with cancer, and surviving cancer, especially U.S. and global populations who experience health inequities. Among its many contributions, the Journal has advanced the field of molecular epidemiology of cancer by providing expert peer review and a highly regarded publications forum and has helped launch the careers of many investigators who conduct population science research on cancer. CEBP plays an active role in informing public health practice, policy, and recommendations by publishing articles that are cited as part of the evidence base, including by the FDA, the Centers for Disease Control and Prevention, the U.S. Preventive Services Task Force, and the World Health Organization. Recognizing the societal need to enhance the translation of population science evidence for cancer prevention and control today and in the future, the Journal recently expanded its scope to include cancer care delivery and implementation science research. Like the other AACR journals, CEBP serves the research community well through its editorial rigor and publication of innovative and impactful research addressing contemporary and emerging cancer problems.As biologic insights into cancer rapidly accelerated in the decades after the discovery of the structure of DNA and the armamenta­rium of anticancer agents began to expand, the AACR identified the need for a communication outlet focused on the clinical applications of these discoveries; Clinical Cancer Research was launched to provide this much-needed outlet. Early therapeutic development has since transitioned from rigidly divided trial phases into an adaptive process that encompasses investigation of safety, pharmacokinetics, proof of mechanism, and first evidence of clinical activity. These same trials now frequently serve as the basis for first regulatory approval. The Journal bridges the transition from late preclinical development, when a new therapy is being paired with insights into the molecular features that predict responsiveness to therapy, to clinical validation of those hypotheses, and the Journal has evolved into a premier venue for phase I/II trials. As the only AACR journal with clinical research of all types, including clinical trials, as its sole purview, Clinical Cancer Research has taken the charge of being the journal that accounts for what happens to the discoveries described in basic and translational cancer research when they are tested prospectively for their potential impact on the outcomes of patients with cancer. Since its launch, Clinical Cancer Research has also played a distinct educational role among clinical oncology journals, with a robust collection of review articles to benefit basic scientists with clinical interests and clinical investigators studying new agents with unique biologic mechanisms of action. Clinical Cancer Research has also become an important forum for critical discussions in clinical oncology. Field-leading experts are invited to deliberate on the progress made in a given therapeutic area, focusing on the lessons to be learned from recent successes and failures. Authors from the FDA provide detailed insights into the data that drive regulatory decision-making for each successful therapy. Clinical Cancer Research continues to demonstrate the AACR's long-standing commitment to accelerating research that leads to potential interventions for prevention, early detection, and treatment of cancer and particularly to showcasing clinical trials.Improving and expanding the arsenal of anticancer therapies is an essential goal in our shared mission to prevent and cure all cancers. From before the humble beginnings of nitrogen mustards and vinca alkaloids to the advent of immuno-oncology and rationally designed targeted therapy, the last 115 years have seen quantum leaps in therapeutic strategies and clinical options to combat cancer. Molecular Cancer Therapeutics has been at the forefront of this effort for more than 20 years, publishing top-tier science in the design, synthesis, discovery, and preclinical study of novel therapeutic agents for the treatment and prevention of cancer. The Journal's scope covers anticancer therapeutics broadly, including precision medicine therapies of all types: cell therapies, gene therapies, RNA therapeutics, oncolytic viruses, and vaccines in addition to established regimens such as mole­cular and biologic agents, chemotherapy, and radiotherapy. Among these efforts, the Journal provides a specialized venue for the first disclosure of experimental therapeutics advancing toward clinical trials, providing a platform with international reach to authors. The crucial role of Molecular Cancer Therapeutics among the AACR journals—and, indeed, among all oncology journals—cannot be overstated. The Journal's laser focus on disseminating rigorously vetted research with near-term clinical benefit has enormous potential to impact the entire cancer research community and to improve, extend, and defend the lives of patients with cancer. To that end, Molecular Cancer Therapeutics continues to provide a vital forum for the communication of important discoveries in cancer therapeutics research to the global research community.Effective global cancer control must emphasize efforts to reduce cancer incidence rather than concentrating solely on cancer treatment. To help catalyze such efforts, the AACR launched Cancer Prevention Research (CaPR) in 2008 to be devoted excl­usively to cancer prevention research. From its inception, CaPR has endeavored to be a primary resource for original articles, scholarly reviews, and timely perspectives regarding basic, translational, clinical, and population science investigations related to cancer risk reduction. Five years ago, CaPR published the landmark perspective, “Transforming Cancer Prevention through Precision Medicine and Immune-oncology,” which proposed a Pre-Cancer Atlas and recognized unprecedented opportunities to interrogate the biology of premalignancy (1). The subsequent development of the Pre-Cancer Atlas, together with other advances, represents a “moonshot” opportunity for the field of cancer prevention. CaPR will continue to cultivate high-caliber content from pioneers in fields such as carcinogenesis, the biology of premalignancy, cancer risk assessment, screening, and policy implementation that will transform the way we detect and, ultimately, intercept and prevent cancer. The Journal's mission to reflect the current state of cancer prevention and to catalyze the development of the field supports the AACR mission to prevent and cure all cancers. The community of researchers, educators, advocates, and funders that works together under the umbrella of the AACR and its family of journals is a critical part of the cancer prevention ecosystem. Together, we are publishing research that defines the field of cancer prevention, building a translational bridge between bench and community, and developing the next generation of cancer prevention researchers.In 2011, recognizing the cancer research community's need for a journal that published the most impactful research while placing a premium on streamlined editorial processes and service to authors, the AACR launched Cancer Discovery. Bringing together basic scientists with detailed knowledge of cancer biology and physicians at the vanguard of science-driven clinical trial design, Cancer Discovery immediately changed the landscape of scientific publishing in the field, with many other journals now trying to emulate the unique mix of basic, translational, and clinical research that the Journal pioneered. Cancer Discovery has been at the forefront of the most important developments in cancer over the past decade, from targeted therapy and immunotherapy to technological advances in single-cell sequencing and liquid biopsy that have fundamentally changed our understanding of cancer biology and response to treatment. Preclinical and clinical studies published in Cancer Discovery have laid the foundation for numerous FDA approvals within a short period, and influential commentaries and reviews have galvanized the field and guided policy decisions. The unique editorial team consisting of leading researchers and experienced professional editors works collaboratively with the community to quickly publish and disseminate the strongest, immediately impactful science to support the AACR mission to prevent and cure all cancers.The first cancer immunotherapeutic is famously considered to have been administered in 1891 by William B. Coley, one of the 11 founders of the AACR, when he used a mixture of heat-killed bacteria (subsequently known as Coley's toxins) to create an inflammatory response that could treat a patient with sarcoma. However, it took more than 100 years before the field of cancer immunology and immunotherapy research gained meaningful traction among those working in the broader discipline of cancer science and medicine. The rapid expansion of the field began in the early 2000s as a result of increasing evidence linking the immune system with cancer development and demonstrations that the immune system might be harnessed to treat cancer, and it has continued at an even more remarkable pace since the FDA approval of the first immune checkpoint inhibitor, the CTLA4-specific blocking antibody ipilimumab, in 2011. Recognizing the need to further enhance interactions between researchers in the realm of cancer immunology and immunotherapy and those in all other areas of the cancer research community, and to provide a forum for the presentation of advances in the rapidly evolving field of cancer immunology science, the AACR collaborated with the Cancer Research Institute to launch Cancer Immunology Research in 2013. Since its inaugural issue, the Journal has disseminated exciting discoveries and developments in the field of cancer immunology and immunotherapy, and successfully introduced the central principles of immunology to cancer biologists and clinical investigators. As a journal devoted to the science underlying some of the most transformative therapeutics to have entered the clinic for the treatment of cancer in recent years, Cancer Immunology Research has played a unique role in advancing the mission of the AACR.Unprecedented progress in understanding the pathogenesis of hematologic malignancies and in translating these insights into improved clinical outcomes has created a demand for a high-profile outlet for publishing these discoveries. To address this need and to emphasize the AACR's commitment to the prevention and cure of all types of cancer, Blood Cancer Discovery was launched in 2020 to inspire, facilitate, and broadly disseminate important discoveries about hematologic malignancies. The Journal's model of operation replicates Cancer Discovery's success in creating synergies between the expertise of leaders in the field and the dedication of in-house editorial and publishing teams, enabling rigorous, rapid, and transparent editorial processes. Blood Cancer Discovery has published cutting-edge research articles on a broad spectrum of topics encompassing leukemia, lymphoma, myeloma, and other blood cancer subtypes that also have profound implications for our understanding of solid tumors. The Journal has also published all the phases of clinical research: drug development in preclinical disease models, clinical trials, molecular events underlying clinical responses and resistance to therapies, and real-world epidemiology. As a forum for diverse ideas shaping future research directions, Blood Cancer Discovery has published incisive commentaries and has partnered with the AACR's hematologic malignancy-focused Special Conferences, quickly emerging as a thought leader in blood cancer research.The landscape of cancer science and medicine continues to change and accelerate, becoming ever more multifaceted. Launched in October 2021, Cancer Research Communications was designed with these considerations in mind. Most crucially, the Journal is fully open access and boasts the broadest and most flexible scope of any AACR title to date, providing a pathway to publication for authors working within funder mandates or whose work falls outside the scope of other titles in the AACR portfolio. The Journal's nine sections offer a comprehensive view of the spectrum of oncology research. With an editorial ethos centered on accessibility, reproducibility, and value to the field, the Journal is inclusive of a wide variety of important research findings that may be beyond the scope of other journals in the program. Cancer Research Communications is committed to catalyzing the rapid dissemination of rigorously peer-reviewed scientific findings in diversified areas of study, including but not limited to physics, engineering, mathematics, and computational biology. This interdisciplinary approach stimulates the cross-pollination of insight and innovation among cancer researchers. Moreover, the Journal emphasizes flourishing areas of research—such as precision medicine, immuno-oncology, and disparities in cancer health outcomes—that will be foundational to the next 115 years of progress against cancer. As a thoroughly modern platform designed to meet the needs of our authors and readers while complementing the other AACR journals, Cancer Research Communications is poised to stimulate the efficient and dynamic exchange of knowledge, actively sparking new ideas and discoveries to prevent and cure all cancers.Since the very first issue of The Journal of Cancer Research was published in 1916, the AACR journals have been a critical resource for cancer researchers and physicians, providing a forum for disseminating groundbreaking discoveries in cancer science and medicine. As the current Editors-in-Chief of the AACR journals, we are proud that this tradition of publishing seminal, rigorously vetted research that can change the trajectory of the field has established the AACR journals as a trusted partner of the research community. Importantly, we would like to take this opportunity to thank our authors, editorial teams, reviewers, and readers for their invaluable contributions to this endeavor. The tireless efforts of this community provide a beacon of hope to patients and their loved ones.As we look to the future, we continue to collaborate with the research community to ensure that the journals operate with a forward-thinking mentality that adapts to the evolving needs of all stakeholders. In recent years, we have seen critical scientific and technological innovations propel extraordinary progress against cancer. We are confident that this progress will continue, and we remain dedicated to ensuring that the AACR journals continue to provide a platform for the communication of impactful research and support the AACR mission to prevent and cure all cancers.L. Cantley consulted for Petra Pharmaceuticals, Agios Pharmaceuticals, EIP Pharmaceuticals, Volastra, Larkspur, and Cell Signaling Technologies over the past year. He also received grant support from the NIH/NCI, Gray Foundation, The Mark Foundation, the Breast Cancer Research Foundation, and Stand Up To Cancer/American Association for Cancer Research over the past year, and is a stockholder in Agios Pharmaceuticals, EIP Pharmaceuticals, Cell Signaling Technologies, Volastra, and Larkspur. R. Dalla-Favera is a consultant for NeoGenomics and AstraZeneca and receives research funds from AstraZeneca. L.A. Diaz is a member of the board of directors of Jounce Therapeutics and Epitope and is a compensated consultant to PetDx, Innovatus CP, Se'er, Delfi, Blackstone, Kinnate, and Neophore. He is an inventor of multiple licensed patents related to technology for circulating tumor DNA analyses and mismatch repair deficiency for diagnosis and therapy; some of these licenses and relationships are associated with equity or royalty payments directly to the inventors. He holds equity in Epitope, Jounce Therapeutics, PetDx, Se'er, Delfi, Kinnate, and Neophore; he divested his equity in Personal Genome Diagnostics to LabCorp in February 2022 and he divested his equity in Thrive Earlier Detection to Exact Biosciences in January 2021. His spouse holds equity in Amgen. The terms of all these arrangements are being managed by Memorial Sloan Kettering in accordance with their conflict of interest policies. K.T. Flaherty reports personal fees from Clovis Oncology, Checkmate Pharmaceuticals, Strata Oncology, Kinnate Biopharma, Scorpion Therapeutics, PIC Therapeutics, Apricity, Tvardi, ALX Oncology, xCures, Monopteros, Vibliome, Soley Therapeutics, Quanta Therapeutics, Nextech, Takeda, Novartis, OMRx, and Transcode Therapeutics and other support from Roche/Genentech outside the submitted work. P.D. Greenberg reports grants and personal fees from Juno Therapeutics; grants from Lonza; personal fees and other support from Earli, Metagenomi, Elpiscience, Rapt Therapeutics, and and grants, personal and other support from outside the submitted work. reports personal fees from reports personal fees from Oncology, Memorial Sloan Kettering Cancer The Institute for AACR, and Cancer Research grants, personal and support from and grants and personal fees from and Jounce Therapeutics; and personal fees and support from outside the submitted work. reports personal fees from and Therapeutics; grants from Novartis, Therapeutics, and and personal fees and grants from and outside the submitted work. were by the other authors.