Еволюція моделей клінічного аутсорсингу на світовому фармацевтичному ринку

Socioeconomically disadvantaged patients, such as persons with low income and those with low educational attainment, are less likely to participate in clinical trials than those with higher earnings and higher educational attainment, despite the former being more likely to have chronic medical conditions. Ways to improve the representation of socioeconomically disadvantaged patients in clinical trials deserve attention. To examine whether current recruitment and enrollment strategies used by US clinical research sites appropriately include patients from socioeconomically disadvantaged backgrounds. This survey study was conducted between April and July 2023. An online survey was distributed among US clinical research sites to explore their use of these strategies and the types of patient sociodemographic and socioeconomic data they collect. The survey was distributed by 13 pharmaceutical companies and 1 clinical research organization. Eight targeted strategies known to increase the recruitment and retention of socioeconomically disadvantaged participants as well as 6 general strategies to recruit and retain clinical trial participants were identified. Data analysis was performed between August and September 2023. Proportions of for-profit vs nonprofit or governmental sites that use recruitment and retention strategies, proportions that have partnerships with community organizations that target socioeconomically disadvantaged groups, and the distribution of sociodemographic and socioeconomic data collected by sites about their patients. A χ2 test of independence was performed to assess the association between research site ownership type and levels of adoption of strategies. A total of 492 responses were collected from 381 clinical research sites in the US (219 for-profit sites [57.5%] and 162 nonprofit or governmental sites [42.5%]). Overall, compared with nonprofit or governmental sites, for-profit sites reported higher use of strategies shown to increase the recruitment and retention of socioeconomically disadvantaged populations, including always or often providing after-hours visits (84 of 173 for-profit sites [48.6%]; 22 of 123 nonprofit or governmental sites [17.9%]) and offering financial compensation (135 of 162 for-profit sites [83.3%]; 60 of 123 nonprofit or governmental sites [48.8%]). Additionally, there was an association between research site ownership type and levels of adoption of these strategies; for example, for-profit sites were more likely to provide after-hours visits (χ2 = 30.33; P < .001) and offer financial compensation (χ2 = 49.35; P < .001). Only 7.2% of for-profit sites (12 of 167) and 13.0% of nonprofit or governmental sites (16 of 123) collected information on the patient's annual income. In this survey study, we found an association between a clinical research site's ownership type (for-profit vs nonprofit or governmental) and how often it used strategies to engage socioeconomically diverse populations in clinical research. Regardless of ownership type, most clinical research sites did not collect socioeconomic information from patients. Adoption of strategies to engage socioeconomically diverse populations, particularly by nonprofit or governmental sites, may help minimize barriers to participation for socioeconomically disadvantaged patients.

AIDS Clinical Trials Is There Access for All?

Introduction: Contract Research Organizations (CROs), Clinical Research Centers/Networks and private research institutions play an important role in the clinical research process, especially in the drug discovery and development process. They act as essential partners for pharmaceutical drug delivery/development and biotech companies. Over the last few decades, the demand for outsourcing of clinical research by pharmaceutical companies has increased, with the market for CRO and private research institutional services growing significantly. This trend has been driven by a need for increased productivity and efficiency to meet the increasing research and development costs, as well as the complexities associated with modern drug development. Statement of objective: This study has an objective to establish CROs with known recognition in sub Saharan Africa. Special emphasis on Cameroon institutions regulating and conduct clinical research. Methodology: Historically, drug discovery services were predominantly conducted in-house, safeguarding intellectual property and close collaboration with internal teams. However, the competitive nature of the sector has motivated pharmaceutical companies to adopt an outsourcing model, allowing them to decentralize, outsourced and exploit specialized expertise and technologies offered by the CROs. These partnerships enable drug developers to accelerate the identification and validation of promising drug candidates through streamlined pre-clinical and clinical trial processes. This is systematic research findings that we conducted a systematic search of the source documents from organizations, access to websites and google search to assemble our information, e-data information system. The systematic search gave us information on the contract organizations with online visibility. Vital information from annual reports, web information system management of the different organizations were accessible for easy navigations. Information on laws governing clinical research and major regulators in Cameroon. Results: Through a systematic online search contract research organization operating in Cameroon and Sub Saharan Africa that were available and accessible on line were identified. The list was not exhaustive as some CROs may be in existence but we could not have access to their activities and home page for enough visibility online. The organizations and CROs operating in Cameroon have been well illustrated. The laws and regulations governing clinical research in Cameroon has been well illustrated. It was observed that CROs face multiple challenges. The Contract Research Organization (CRO) are faced with multiple challenges that can be a limiting factor to their growth and quality service delivery: These challenges are listed though not exhaustive as Technological Disruption, Regulatory landscape, intellectual Property Issues, Economic Volatility, Limited Human resource expertise, Return on investment/High Costs: Conclusion/Recommendation: The CROs in Cameroon are required to be in compliance with the law regulating research in human subjects of 2022 and the regulations on Clinical research in Cameroon. In sub Saharan Africa CROs are aligned with the regulation enforced in their different countries. The success of CROs is based on their compliance to innovative trends in clinical research and the capacity to strengthen collaboration among policy makers and actors. The ability to face challenging opportunities in clinical research and embrace transformative breakthroughs that can bring faster new chemical entities to the market at the same time improving the standard of care (SOC) of the population. In the future, the synergy between innovation, strategic partnerships, and a commitment to excellence for CROs shall be the cornerstones of future success in conducting clinical research for Pharmaceutical drug discovery and development Based on the regulatory demanding nature of clinical regulation in Cameroon CROs must have a legal jurisdiction and recognition of their operation, and conform to the norms and standard laid down by regulatory authorities and the states of their jurisdiction CROs offer a wide range of services to support the development and execution of clinical trials, ensuring compliance with regulatory requirements and ethical standards. Clinical Research Organizations (CROs) play a pivotal role in the pharmaceutical, biotechnology, and medical device industries as a research service delivery provider on a contract basis.

Even though the public has been exposed to a tremendous number of recruitment ads with over a half billion spent annually on advertising specific trials, response rates are as low today as they were twenty years ago. What steps are necessary to improve recruitment for cancer prevention research? The first critical step is public education that is not study specific, that addresses the broader benefits of clinical research, and that is collectively embraced by all the stakeholders in clinical research and healthcare. The need for outreach and education is clear: 74% of the public say that they have no “real” knowledge of the clinical research process, and 98% don't know where and how to identify and evaluate appropriate clinical studies. Furthermore, there is an erosion of confidence in the clinical research enterprise that is rooted in many causes, including widespread media coverage of industry missteps and tragic errors resulting in harm to patients. These have contributed to an atmosphere of suspicion and doubt which have left the public troubled and confused. If we are to engage the public, the stage must be set for the message to be heard and that calls for a national public education media campaign. With pro-bono support from the international advertising and marketing agency Ogilvy &amp; Mather, a new public service campaign has been developed to educate and win over the public about the importance of clinical research participation. During the campaign's yearlong development process and extensive focus group testing, strong support was expressed for Medical Heroes' easy-to-remember messaging and acknowledgement of ordinary people's contributions to public health. During screenings before test audiences, the ads were lauded for their “humanity and emotional appeal,” as viewers declared, “These people are heroes in their own way,” “They've done something great for all of us,” and “I see the benefit of clinical research to society.” The Medical Heroes campaign has been market tested in 30 sites across 18 U.S. markets by Eli Lilly and Company. In wave 1 of the market test, the control group was established as 12 markets that ran their typical recruitment ads; in 6 comparable markets, concurrent Medical Heroes ads were run as well as recruitment ads — and these markets showed a 38% increase in patient recruitment rates over the control group. The test was repeated and the results of wave 2 showed that response rates to recruitment ads more than doubled in the markets where the Medical Heroes campaign was also run. The campaign met its ultimate goal of providing the public with an increased awareness of research participation and an improved perception of clinical research volunteers. Implementation of the Medical Heroes national media plan is enabling the campaign to reach over 120 million people quarterly through print, radio and TV ads. In order to dramatically increase the reach and frequency of this important public service message, CISCRP provides the Medical Heroes print, radio and TV ads to all those organizations who contribute to the national campaign — which enables these organizations to run the Heroes ads in their local markets. This broad public awareness is encouraging more people to seek information about clinical trials prompting a greater need for educational tools in the form of easy-to-read brochures, DVDs, and newsletters. CISCRP has a growing collection of educational brochures that take complex questions about clinical research and put them into everyday language. Foremost among the materials is the Education Before Participation series, widely used today by universities, hospitals, clinical research organizations, Boards of Health, civic organizations, and community health clinics to educate people about clinical trials and the need for participation. Expanding the outreach to minority audiences, CISCRP has also developed customized versions for African Americans and Hispanics, and has translated the brochures for use globally with country-specific lists of government, disease-advocacy, and industry resources for residents of Argentina, Brazil, Canada (French speaking), China, Czech Republic, France, Germany, India, Italy, Mexico, Netherlands, Philippines, Poland, Russia, South Korea, Spain, and Ukraine. By providing valuable information about the benefits and risks of participation, questions to ask, and places to find more information, the Education Before Participation series is a valuable tool for beginning the discussion with prospective clinical research volunteers. Clinical research sites have found that these brochures ease the informed consent process. Beyond the use of educational brochures, there is real value in providing the public with disease-specific educational DVDs that use the voices and images of real-life volunteers and healthcare experts. Input from prominent African American and Hispanic researchers and physicians was obtained to help guide the content and earmark culturally relevant issues as well as ethnomedical values and beliefs. The DVD series targets specific areas such as clinical research and cancer, diabetes, mental illness, breathing problems, and heart disease. CISCRP plans to continue the clinical research series with additional disease-specific educational DVDs. Such DVDs have great impact when they are being shown on a loop in waiting rooms, and they can also be posted on websites. Most important is providing prospective volunteers with DVDs to be watched at home-as a tool to help them influence their families and friends who criticize them for choosing to be “guinea pigs.” Another educational tool is The Medical Heroes newsletter, published by CISCRP every other month throughout the year. The newsletter focuses on subjects that matter to current and future clinical research volunteers, and provides ongoing information and valuable resources. A look at some recent issues offers insight into the newsletter's impact. In one edition, the inspiring story is told of John Cleland, who was successfully treated for metastatic testicular cancer in a clinical trial of the drug cisplatin 36 years ago. In another issue, an article addresses readers' fears about getting a placebo. Another article explains the process of accrediting human research protection programs and why participants need to know about it. Beyond educational tools, outreach is critical to the learning process. CISCRP conducts events entitled “AWARE for All-Clinical Research Education Days” in major cities across the United States. These free public programs are the culmination of a 3- to 6-month outreach process. AWARE brings together disease advocacy groups, hospitals and healthcare organizations, educational institutions, and community organizations to provide health information and exhibits, as well as free health screenings. In addition, distinguished local politicians and opinion leaders, physicians and healthcare providers, and clinical research professionals serve as keynote speakers and workshop leaders-all volunteering their time on a Saturday to help educate the public. In each AWARE location, CISCRP's outreach efforts take many forms. Active contact is made with 30 to 50 community partners, and personal outreach and education is extended to the distinguished members of each city's Honorary Committee. Local churches, community and health centers, and disease-specific organizations give grassroots support by bringing AWARE's message directly to their constituents. To date, close to 300,000 people have been impacted by the program. AWARE has put a human face on the people who volunteer for clinical trials while building public understanding of the risks and benefits of participating. AWARE is building a movement at the local level and there is a need to bring this form of outreach to many more communities. When asked whether they are more likely or less likely to participate in a clinical trial after attending AWARE, 75% of the attendees respond, “more likely.” With all of the information about clinical research that is available online, what the public wants most can be difficult to find. In a CISCRP survey of more than 4,500 online registry users, the public explained that they are not concerned about the volume and sophistication of clinical trials data they can find online. Instead, users want easy-to-process trial summaries that help them find trials in convenient geographic locations as well as contact information for those trials. These eye-opening findings prompted the development of CISCRP's free public service, www.SearchClinicalTrials.org (SCT). Launched in November 2006, this online tool uses sophisticated technologies to scan the web and compile clinical trial listings and results in one location. But when the online search is too difficult, the public is urged to call CISCRP. Their search request is fulfilled via mail or email and includes an educational brochure as well as contact information for research site staff who can help them decide if the trial is right for them. Education and outreach are the keys to increasing trust and understanding. Working together across the industry - healthcare, patient advocacy, government, and research professionals -can provide the public with educational resources and shift the public's mindset from confusion and concern to recognition and appreciation. From CISCRP's point of view, it's time to say “Thank You” to the millions of people globally who give the gift of p

<p indent="0mm">A clinical trial is a key step in the process of pharmaceutical research and development (R &amp; D). It is a key indicator of the innovative potential of the pharmaceutical industry. ClinicalTrials.gov shows that the average annual growth rate of the total number of clinical trials globally in the past decade (2012–2021) was 20.7%, mainly distributed in Europe and the United States, and the total number of clinical trials registered in China accounted for 6% of the world. According to the statistics of IQVIA Institute for Human Data Science, the global proportion of early-stage R &amp; D pipelines from China-headquartered companies increased from 1% in 2005 to 12% in 2020, which was still far behind that of European and American companies. Among 871 new active substances approved for marketing globally in the past two decades, 522 were for marketing in China, with the high number driven by regulatory acceleration mechanisms from National Medical Products Administration, such as breakthrough and orphan designations and priority reviews. Considering the gap in clinical research strength between China and developed countries such as Europe and the United States, the clinical trial research capacity and level should be improved to assist China in the R &amp; D of innovative drugs. According to the Registration and Information Disclosure Platform for Drug Clinical Studies and the clinical trial institution filing management information platform in China, in the last five years (2017–2021), the average annual growth rates of the total number of new drug clinical trial registration and clinical trial units in China reached 26.9% and 12.6%, respectively. However, clinical trial resources are mainly concentrated in major institutions, municipalities, or provincial capital cities in the eastern and central regions of China, with distributions becoming increasingly polarised. Under the background of China’s new medical reforms, the strategic direction of national political support is to motivate equitable access to high-quality clinical trial resources and cross-regional collaborative development of medical institutions by means of medical unions, national clinical medical research centres, Chinese national major projects for new drug innovation and so on. In the context of this background, clinical trial research unions (CTRUs) have been built in China. A CTRU is defined as a consortium formed by medical institutions, sponsors and third-party service institutions of various levels and functions, led by a national clinical medical research centre or clinical trial medical institutions undertaking major national science and technology projects or supporting projects of national key R &amp; D plans, radiating and driving the improvement of clinical trial research capacity in multiple regions. CTRUs develop a multi-level clinical research centre system and collaborative network by vertically and horizontally combining multi-level medical institutions, sponsors and third-party service institutions. All participants of CTRUs are crucial. The leading clinical trial research medical institution, as the core, is responsible for establishing institutional system standards in CTRUs, designing and leading high-quality multi-centre clinical trials, central ethics and personality training. The major clinical trial research medical institutions are responsible for implementing high-quality, multi-centre, complex and high-risk clinical trials. The other member institutions are responsible for implementing basic clinical trials. The sponsors, contract research organizations (CROs), site management organizations (SMOs) and other enterprises are responsible for funding, supporting and promoting the construction of a clinical trial centre system and collaborative network. The specific construction contents of CTRUs include building a clinical trial research resource sharing platform, homogenising clinical trial quality management, constructing a rapid clinical trial process platform, diversified multi-level and multi-form talent training, information interconnection, deepening strategic cooperation and designing and leading high-level trials. CTRUs have established the selection criteria and assessment exit mechanism and conducted work performance assessments from the dimensions of organisation and implementation, division of labour and cooperation, the connection of clinical trial resources from top to bottom, efficiency and benefit and sustainable development to ensure their good and sustainable development. Through CTRUs, we can achieve high-quality clinical trial resource sharing, improve the clinical trial research capability of member institutions, cultivate high-level skills, such as principal investigators (PIs), sub-investigators, institutional managers and clinical research coordinators (CRCs), and promote the development of clinical trials, economically and with high-quality. Through the trial operation with one member of CTRUs, it was found that the key points should be strengthened in deepening resource sharing, implementing central ethics review, interconnecting information platforms and leading high-quality clinical trials. The construction of CTRUs is an effective means for China’s clinical trial research to solve the current problems and change from a ‘follow-on pattern’ to leading high-level and high-quality international multi-centre trials. However, the construction of CTRUs is a complex systematic project. In addition to performing an excellent job in the top-level design and overall planning, CTRUs’ specific implementation process and measures need to be continuously explored in the practice process.

Roles of contract research organizations in translational medicine

At some stages of their careers many Family Physicians and General Practitioners will be approached by a pharmaceutical company or a 'clinical research organisation' (CRO) to be an investigator in a clinical trial. According to the South African Clinical Trials Guidelines 2000; a clinical trial is '[a]ny investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product[s], and/or to identify any adverse reactions to an investigational product[s], and/or to study absorption, distribution, metabolism, and excretion of an investigational product[s] with the object of ascertaining its safety and/or efficacy.

Background Italy is Europe’s third largest pharmaceutical market, yet it ranks only ninth in the number of NIH-registered clinical trials per capita. The aim of our study was to explore stakeholders’ perception of Italy as place to undertake clinical trials, and to estimate the potential economic impact of selected reforms in terms of incremental trial activity. Methods The Survey of Attitudes towards Trials in Europe (SAT-EU Study) was an anonymous, web-based survey which systematically assessed factors impacting clinical trial site selection in Europe. Estimates of Italian economic impact were developed in collaboration with AICRO (Association of Italian Contract Research Organisations). Results Responses were obtained from 485 professionals in 34 countries (15% residing in Italy) representing over 100 institutions, spanning BioPharma Clinical Research Organizations (CROs), and Academic Clinical Trial Units (CTUs). Italy ranked tenth of twelve in terms of accessibility and transparency of information required to run clinical trials, and last with respect to predictability and speed of Ethics Committees. Costs of running clinical trials were not considered critical, whereas, fragmented and slow approval process was. Streamlined centralized trial authorization would translate into an estimated 1.1 billion Euros of incremental trial investments over three years. Conclusions Clinical trial professionals consider Italy’s governance of clinical research suboptimal, among the worst in Europe, and indicate that much could be done to make Italy more attractive for clinical trial investments. The present study also provides evidence about stakeholders’ willingness to invest in trials and its economic consequences provided effective reforms are put in place.

IntroductionThe development of medical knowledge has involved increasing numbers of clinical studies, including trials of treatment modalities among elderly individuals. We evaluated knowledge about and attitudes on participation in various clinical trials among elderly individuals.MethodsA semi‐structured survey was developed and distributed to community‐living elders who agreed to participate in the Ansan Geriatric Study. Survey items addressed (i) the process of acquiring consent, (ii) the advantages of participation in clinical trials, (iii) worries about participation, (iv) clinical field trials in which they would like to participate, and (v) reasons behind participation.ResultsA total of 361 individuals (158 women and 203 men, mean age 71.1 years) agreed to answer the survey about clinical trials. The reported advantages of participation in clinical trials were access to cost‐free medication or interventions (44.9%), prevention or early diagnosis of possible future diseases (23.8%), diagnostic and laboratory tests at no charge (14.7%), and contribution to human wellbeing (13.3) The reported disadvantages were the possibility of side‐effects from the new treatments (32.1%), giving blood for frequent laboratory tests (28.5%), concerns about intrusions on human dignity (9.9%), and possible leakage of personal identifying data (8.6%). An additional 10.8% saw no disadvantages. Subjects were interested in participating in clinical field trials for interventions or medication to treat metabolic syndrome and medical diseases (43.5%), Alzheimer's and Parkinson's diseases (11.1%), late‐life depression (2.5%). Although more than two‐thirds (77.3%) of the subjects believed that they should provide consent for themselves, some believed that their spouses (14.4%) or other family members (8.3%) should be able to receive the explanation of the clinical trial and sign the informed consent forms.DiscussionWe should consider the attitudes of elderly participants during the processes of explaining clinical trials and acquiring consent.

Background: Individuals from diverse racial/ethnic and disadvantaged backgrounds are underrepresented in cancer clinical trials, compounding the difficulty of adequately understanding, addressing, and reversing health inequities. Social determinants of health (SDOH) factors likely contribute to disparities in cancer trial enrollment. While the presence of SDOH has shown to be associated with clinical trial participation, few studies have explored the role of SDOH in shaping beliefs around the benefits of clinical trials. Thus, this study aims to identify SDOH factors associated with beliefs around the benefits of clinical trial participation. Methods: This is a cross-sectional study of data from the Community Health Assets and Resilience Measures survey. The survey was administered in Fall 2021 to community members (N=3593; 98% &amp;gt; 50 years of age, 68% male, 52% racial/ethnic minority) residing in three states within the Mayo Clinic catchment area. Survey items assessed SDOH factors including financial instability, childcare, transportation, food insecurity, safety, literacy, social isolation, and perceived discrimination. Participant beliefs around the benefits of clinical trial participation was measured by rating level of agreement to 4 statements: ‘People in my community can benefit from participating in clinical trials’, ‘Participation in clinical trials benefits society’, ‘Participation in clinical trials is risky’, ‘I would personally benefit’, and ‘People in my community would benefit’. Response options were dichotomized as ‘agree’ and ‘disagree’ and adjusted stepwise logistic regression analyses were performed to assess factors associated with beliefs about clinical trials. Results: Race/ethnicity was significantly associated with all beliefs with Indigenous populations being significantly more likely to agree that people in their community could benefit from clinical trials, clinical trials benefit society, participation in clinical trials is risky, and that they would personally benefit. In adjusted analyses, financial instability, food insecurity, transportation, childcare, safety, social isolation, literacy, and discrimination were significantly associated with beliefs about the benefits of clinical trial participation. Neighborhood safety was most strongly associated with the belief that ‘People in my community can benefit from participating in clinical trials’ and ‘I would personally benefit from clinical trials’. Health literacy was most strongly associated with the belief that clinical trials benefit society and the community. Finally, the experience of 'people act as if they think you are not smart' (discrimination) was most strongly associated with the belief that clinical trials are risky. Conclusion: Clinical trials are the cornerstone to advancing equitable cancer care. Innovative, multifaceted, community-driven strategies are needed that address negative beliefs around the benefits of clinical trial participation to address existing recruitment and retention shortcomings. Citation Format: Jessica D. Austin, Todd Huschka, Amelia Barwise, Megan Allyse, Sean Phelan. The role of social determinants of health on beliefs around the benefits of clinical trials [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr A077.

Distance to Care Predicts Clinical Trial Enrollment on COG ALL Clinical Trials: A Report from the Children's Oncology Group

This study compared rates of clinical trial participation and perceived adequacy of information provided prior to consent in migrant and Australian-born cancer patients, and explored factors associated with being approached and agreeing to participate. We utilized data from a larger cross-sectional survey assessing disparities in patient-reported outcomes in Chinese, Arabic, or Greek migrant versus English-speaking Australian-born cancer patients. Participants completed a questionnaire eliciting demographic and disease details, communication challenges, whether invited and consented to a clinical trial, and if so, adequacy of information received. A total of 566 migrants (142 Arabic, 251 Chinese, and 173 Greek) and 270 English-speaking Australian-born patients participated. Overall, 25% were approached to participate in clinical trials, and of these, 74% consented. Migrants were significantly less likely to consent if asked to participate in clinical trials (P = .009), and fewer migrants (67.2%) reported receiving sufficient information prior to deciding on trial participation (82.1%; P = .04). Perceived understanding of the health system (odds ratio [OR] = 0.71), confidence in speaking (OR = 0.75), ability to understand English (OR = 0.80), and communicate with doctors in English (OR = 0.81) were significantly related to patients' likelihood of being approached to participate in clinical trials. Perceived understanding of the health system (OR = 0.66) was significantly associated with patients agreeing to take part in cancer clinical trials. Our findings identified that barriers to migrants' self-reported participation in clinical trials include perceived lack of understanding of the health system and low English proficiency. Strategies that address these barriers are needed to increase migrant patients' participation in cancer clinical trials.

Background: Although a number of experimental therapies for spinal cord injury (SCI) have recently emerged, few authors have examined the goals of individuals with SCI considering experimental therapies, and none have determined whether sociodemographic and injury-specific characteristics influence that engagement. Objectives: To determine (a) the goals of individuals with SCI who are considering experimental therapies; (b) whether sociodemographic factors, injury-specific characteristics, and concerns over adverse events influence those goals and/or participation in experimental therapies and clinical trials; and (c) whether people with SCI feel they have adequate information about experimental therapies and clinical trials. Methods: An online survey that yielded 364 responses. Results: Most respondents (83.7%) had sought information about experimental therapies, and just under half (47.8%) had received one. The most frequently cited functional goals were improvement in bowel and bladder function and elimination of dysreflexia (60.4%). Several goals were influenced by age and level and completeness of injury, and most respondents (93.4%) wanted more information about experimental therapies. Just over one-third (34.6%) of respondents had participated in a clinical trial, and nearly all (96.9%) wanted more information about them. Having received experimental therapies and participated in clinical trials was positively correlated with seeking SCI-specific care from an SCI specialist rather than from a primary care physician. Most (83.9%) respondents would avoid or be reluctant to engage with a medical center if they were made aware of harm done to trial participants. Conclusion: This work suggests that there are unmet information needs among people with SCI, specifically pertaining to experimental therapies and clinical trials. It also reveals that improved access to SCI specialists may enhance access to novel treatments and research efforts. Being made aware of harm to trial participants may influence the decision of individuals with SCI to seek care at or enroll in trials at these clinical sites.

Having diverse participants in clinical trials ensures new drug products work well across different demographic groups, making health care safer and more effective for everyone. Information on the extent of Native Hawaiian and Pacific Islander participation in clinical trials is limited. To examine representation of Native Hawaiian and Pacific Islanders in clinical trials leading to the first US Food and Drug Administration (FDA) approvals for the 10 drug products with the top worldwide sales forecasts in 2024. Cross-sectional secondary analysis of existing data from clinical trials that took place from 2006 to 2021 in the US. All clinical trials that were included in the FDA first approval application for the 10 drug products were evaluated in this study. Data were analyzed from February to August 2024. Participation in a clinical drug trial. Comparison of the proportion of Native Hawaiian and Pacific Islander participation in clinical trials for the 10 drug products with top sales forecasts in 2024 to the Native Hawaiian and Pacific Islander population proportion. In this cross-sectional study of 139 062 individuals, Native Hawaiian and Pacific Islander participation in clinical trials for the 10 drug products with top sales forecasts was either unknown or low. For 6 of the 10 drug products (60%), the number of Native Hawaiian and Pacific Islander participants was not documented. All trials that reported Native Hawaiian and Pacific Islander participation had fewer Native Hawaiian and Pacific Islander participants than would be expected based on their US population proportion, with 2 of the differences being statistically significant. Of the trials that disaggregated Native Hawaiian and Pacific Islander participants from other racial groups, the number of Native Hawaiian and Pacific Islander participants was 8 for risankizumab-rzaa (0.38% of participants vs 0.49% of the population; percentage point difference, -0.11%; 95% CI, -0.37% to -0.15%), 7 for bictegravir/emtricitabine/tenofovir alafenamide (0.38% of participants vs 0.49% of the population; percentage point difference, -0.10%; 95% CI, -0.39% to 0.18%), 27 for 4vHPV/9vHPV (0.15% of participants vs 0.46% of the population; percentage point difference, -0.31%; 95% CI, -0.37% to -0.26%), and 90 for BNT162B2 COVID-19 vaccine (0.20% of participants vs 0.52% of the population; percentage point difference, -0.32; 95% CI, -0.36% to -0.27%). In this cross-sectional study, limited documentation and participation of Native Hawaiian and Pacific Islander individuals in clinical trials for drug products with top sales forecasts was found. This is especially concerning because Native Hawaiian and Pacific Islander individuals have a higher risk than other racial groups for type 2 diabetes, cancer, and several other conditions the products examined in this study treat. Given the importance of enrolling Native Hawaiian and Pacific Islander participants in clinical trials, sites should be established in key geographic regions, such as Hawai'i, and postmarket studies should be conducted within Native Hawaiian and Pacific Islander populations.

Racial Disparities and Their Impact on Knowledge, Behavioral Patterns, and Preferences Towards Participation in Clinical Trials Among Cancer Patients