Patient perspectives on research gaps in cluster headache.

AIDS Clinical Trials Is There Access for All?

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% > 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

Motivation and frustration in cardiology trial participation: The patient perspective

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.

In its publication ‘Best Research for Best Health’1 the UK government has emphasised the fundamental importance of high-quality clinical research relevant to patient needs within the NHS. The present day framework of NHS Research & Development began some 15 years ago with the Culyer Report2 when a strategy for ring-fenced funding and support for research in the NHS was determined. Since then the terms and conditions for the conduct of research and its governance have evolved,3 with the national health strategy now firmly directed at improving the research culture within the NHS environment as part of the Department of Health's 10-year Science and Investment Framework 2004–2014. ‘Best Research for Best Health’ states that ‘people should be placed at the centre of the research system’ and that patients should be encouraged to engage in the research process at all levels, including ‘identification, design, recruitment to and dissemination of research projects’. In essence, a partnership should take place between the patient and the investigator enabling a better understanding of the needs of people affected by medical conditions and ensuring early access to new interventions and prevention strategies through high-quality protocols. The National Institute for Health Research (NIHR) manages a Clinical Research Network (UKCRN) providing support and coordination for research within the NHS and, of eight Topic-Specific Clinical Research Networks (TCRNs) that have been prioritised, the Diabetes Research Network (DRN) serves to improve integration of research and to encourage a wider participation in diabetes-related clinical trials. Presently, the DRN has incomplete distribution across the UK geographical land-scape, but in areas without coverage, in England at least, alternative provision is being taken on by separate Comprehensive Local Research Networks (CLRNs). So far it is early days, but already the Network is supporting a number of peer-reviewed multi-centre projects considered to have potential clinical benefits to people with diabetes. It is anticipated that the majority of research within the NHS environment, be it portfolio, joint academic or commercial studies, will be channelled through the Network and ongoing local ‘own account’ research will be encouraged to secure ‘adoption’ by a central Network peer review panel including lay advisors. Multi-centre studies frequently involve a partnership between the NHS and the pharmaceutical industry. Involvement in such commercial research has always been an important part of a local diabetes service activity, enabling early, cutting edge experience of new therapeutic developments. However, there have been concerns4 that the UK investigator may be becoming less competitive with a slowness to initiate trials, a failure to meet recruitment targets and excessive costs compared to the international market—all adversely affecting the UK as a source of favoured trial sites. An advantage of the various Networks should be to address these issues, identifying ‘good sites’ and supporting a greater efficiency of trial conduct. One crucial issue determining the success or otherwise of clinical trial outcome is very much the good-will of patients prepared to be involved in research studies. The importance of securing patient motivation and participation is recognised both by the UK Diabetes Research Network5 and by INVOLVE,6 a national advisory group funded by the NIHR to support and promote active public involvement in NHS research. Endeavouring to understand which factors most influence a patient's decision to participate in research studies, using a Lickert scale-based questionnaire,7 we have found that people with diabetes have various reasons for participating in clinical trials. Significant motivating factors included improving their own health, helping relatives and advancing science. Of particular note was the finding that a face-to-face discussion with the diabetes consultant proved to be the most influential means of achieving patient participation emphasising the responsibility of trust that rests with the investigator. Recognising this invaluable need for patient and public involvement in clinical trials, the UK Diabetes Research Network has established a dedicated Advocacy Group,8 combining health care professionals and several lay members, to champion all these matters and to share the patient perspective of participation. In this issue (p 216), the Advocacy Group reports an innovative practical resource in the form of an educational DVD which, based on video interview of patients with positive previous clinical trial experience, is being used to recruit patients from primary care, where care for the majority of people with diabetes is now provided. A large proportion of future trials in diabetes will need to seek patient participation from general practice, with integrated research adapting along similar lines to present integrated clinical care models of service. This Diabetes Network Advocacy Group resource provides a useful means of promoting research understanding and facilitating patient participation within the new NHS research framework.

Cluster headache (CH) is intricately linked to diverse risk factors, spanning hereditary, environmental, and lifestyle elements. This systematic study, guided by PRISMA guidelines, delves into the prevalence, risk factors, and management of CH. Examining English-language articles from 2010 to 2023 via PubMed/Medline, Scopus, and Embase, our findings reveal a significant association between cluster headaches and factors including family history, smoking, alcohol consumption, male predominance, and head trauma. Notably, a reevaluation of sex discrimination in familial cases is warranted, given the observed female predominance in familial history and CH association studies. Reviewing 739 studies, 7 met inclusion criteria, predominantly utilizing surveys and national database analyses (n=7). Improving our grasp of diagnosis and treatment holds promise for future evaluation and management. Our conclusion underscores global variability in CH prevalence, urging more rigorous population-based surveys. The substantial and persistent burdens associated with CH, from suicidality to economic stress, underscore the need for comprehensive research and intervention. CH transcends the label of a mere \"trigeminal autonomic headache,\" showcasing a diverse spectrum of attack and bout characteristics across countries and ethnicities. Despite the global efficacy of current diagnostic criteria, CH emerges as a dynamic illness, demonstrating progression or regression over time. This underscores the necessity for further research in comprehending its trajectory.

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.

Introduction Cluster headache (CH) is the most common trigeminal autonomic cephalalgia with a significant need for novel treatment options. While the use of most of the acute CH medications is supported by clinical trials and based on a pathophysiological concept for the generation of pain, the scientific evidence for preventive CH medications is very limited. Areas covered This article reviews acute and preventive substances for the pharmacological treatment of CH with a focus on the mode of action of these drugs. We also summarized the clinical trial evidence and discuss future research directions. Expert opinion Recommendations for current pharmacological CH therapies, in particular for CH prevention, are often based on small open label studies with inconclusive results. Larger trials are missing. A shared pathophysiological mechanism of action of these preventatives does not exist. Future studies with CGRP(R) antibodies and novel substances with specific actions are needed and will thereby help to understanding the pathophysiology of CH.

In this secondary analysis of the Clusterbusters® Medication Use survey, the use, effectiveness, and tolerability of inhaled oxygen were investigated and compared with injectable sumatriptan. We also sought to understand the predictors of medication response. Inhaled oxygen is a mainstay abortive intervention in cluster headache but is not approved by the Food and Drug Administration (FDA). Unlike injectable sumatriptan, the only FDA-approved pharmacologic intervention for cluster headache, oxygen can be used multiple times a day, which is highly relevant for a condition with numerous daily attacks. In addition to obstacles in obtaining oxygen therapy, optimal oxygen delivery (ie, mask, flow rate) is not uniformly employed in cluster headache. These factors lead to underuse and imprecise therapeutic response rates. A secondary analysis was conducted using deidentified data from the Clusterbusters® Medication Use survey, which was modeled after previously published surveys and available online. Subjects were recruited from headache clinics and cluster headache websites. Most responses were chosen from a list; others were free-texted. The final analysis included responses from 493 adult participants with a validated diagnosis of cluster headache. This analysis of deidentified data from the Clusterbusters® Medication Use survey received institutional approval. The most commonly used delivery system used by subjects was a non-rebreather-type mask. The use of oxygen flow rates >10 L/min was a positive predictor of medication response (OR=2.36, P=.016). Among those who used flow rates >10 L/min, both inhaled oxygen (81.5%) and injectable sumatriptan (80.5%) were efficacious and did not differ significantly from each other in any specific group examined. At flow rates >10 L/min, positive predictors of oxygen response were male gender (OR=2.07, P=.031) and cigarette smoking (current or historical; OR=2.25, P=.017). Among the groups examined, there were no predictors of sumatriptan response. Most comments about side effects and concerns were directed at triptans. Therapeutic response to inhaled oxygen at sufficiently high flow rates (>10 L/min) had comparable efficacy to that of injectable sumatriptan for the acute treatment of cluster headache. Other factors in oxygen delivery (ie, flow rate changes) should be explored for optimization of therapy. The reasons for improved oxygen response in males and those with a cigarette smoking history require further exploration. While both oxygen and sumatriptan can be effective in the management of cluster headache, patient-reported side effects and concerns were more commonly directed at triptan medications. Current restrictions on access to inhaled oxygen, which exist at many levels, limit the therapeutic options available for patients with cluster headache, thereby doing a disservice to this patient population and the providers who deliver their care.

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.

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

Purpose African American breast cancer patients remain significantly underrepresented in clinical trials, despite experiencing more aggressive disease and disproportionately worse outcomes. While awareness of clinical trials has increased, there is still a gap between awareness and participation, especially due to limited access to personalized support and actionable next steps. BreastCancerTrials.org and Sisters Network® Inc. partnered to assess attitudes, knowledge, beliefs, and experiences related to clinical trials as part of a larger initiative to improve trial awareness and enrollment in African American women. Methods Sisters Network® Inc distributed a survey to over 100 African American breast cancer survivors affiliated with the organization to gather insights on their knowledge, experiences, and beliefs about clinical trials. As the largest national African American breast cancer survivorship organization with more than 30 chapters across the U.S., Sisters Network® Inc utilized its extensive network to reach a broad and diverse community of survivors. The survey asked about participants demographics, breast cancer details, and familiarity with clinical trials. It covered communication with healthcare providers, trial eligibility and experience, barriers to participation, challenges finding trial information, and interest in using clinical trial navigation for support. Results Preliminary findings show that more than 65% of respondents were familiar or somewhat familiar with clinical trials. When asked about participation, 44% said they would join a trial if their healthcare provider offered it as an option. Most participants lived in urban (51%) or suburban (46%) areas and were early-stage breast cancer survivors. Specifically, 14% were diagnosed at stage 0, 34% at stage 1, 46% at stages 2 or 3, and 3% had metastatic cancer. Regarding biomarker status, 34% reported being ER/PR positive, 21% had Triple Negative breast cancer, and 22% were unsure of their status. Thirty percent of respondents had discussed clinical trial participation with their healthcare team. Of those, 67% said the healthcare team initiated the conversation, while 16% reported bringing it up themselves. Key barriers to clinical trial participation included difficulty determining eligibility, challenges finding a trial, and limited understanding of how trials work. Despite these challenges, most respondents expressed interest in learning more. Over half indicated they would be interested in clinical trial navigation services, with 52% identified as having interest in receiving education and support from a clinical trial navigator. Conclusion This study further demonstrates the barriers that African American breast cancer patients experience, and the fact that they could benefit from culturally competent, personalized navigation. This survey was the first step in a broader effort to build trust and increase clinical trial knowledge, awareness, and participation among African American breast cancer patients through the development of customized, culturally responsive education programs and navigation support. BreastCancerTrials.org and Sisters Network® Inc. efforts to improve access and diversity in clinical trials will support broader initiatives within both organizations. Insights from this study will also help refine our enrollment strategies for the I-SPY clinical trials. Citation Format: S. Mayhew, S. Colen, L. Patel, S. Horton, K. E. Jackson, C. Allen, O. Akanni, J. LaCoursiere, T. Heather, E. Laura. Listening to the Community: Barriers and Beliefs About Clinical Trials Among Black Women with Breast Cancer [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS4-09-01.

Background: African Americans (AA) populations are among the most impacted by different types of cancers in the U.S. compared to other racial/ethnic groups. Among them, cancer clinical trials enrollment rates continue to be disproportionally low. Whites/Caucasian individuals comprise about 67% of the US population although having a 75% enrollment rate in clinical trials. Black/AA individuals comprise 13.4% of the US population although having a clinical trial enrollment rate of less than 5%. Participation of African Americans and African Nationals (AN) will significantly increase the state of knowledge regarding cancer treatment, survival, behavioral and pharmaceutical therapeutics, precision medicine, and increase access to the newest cancer therapies and can help improve cancer outcomes. Therefore, improving clinical trial participation among AA/AN patients is fundamental to reduce cancer health disparities. However more culturally focused information is needed addressing barrriers to clinical trials participation in these groups. Methods: We conducted 6 focus groups with 42 participants and two Town hall meetings with 120 participants targeted to AA/AN communities, where we gathered information about barriers to participation in research and clinical trials. We also reached out to 48 Black churches to discuss partnerships for dissemination and listen to concerns regarding AA participation in research. We leveraged our experience at USC NCCC where we have seen an increase of 147% in AA participation in clinical trials since 2015. Utilizing lessons learned and strategies identified we developed an AA/AN Clinical Trials Toolkit for CT outreach to inform about CT enrollment in Los Angeles County. The manual was culturally adapted to convey messages on clinical trials, using infographics and educational videos by cancer researchers, guided by persons living with cancer and other key stakeholders. Results: More than 160 stakeholders provided information in the creation of the AA/AN manual to include pastors, and other additional stakeholders. The manual was culturally adapted to convey lay messages on clinical trials addressing barriers to participation, using infographics and educational videos by cancer researchers. We found that partnering with pastors in the faith-based community was one of the most trusted ways of approaching this topic in the AA/AN community. Once the AA/AN manual was developed, stakeholders were asked to contribute to community wide dissemination and uptake. To date (6/6/2022), 62 churches in Los Angeles County serving AA/AN communities have been provided with a virtual copy of the Clinical Trials manual to be disseminated among their communities. The manual was launched and widely disseminated between November and March of 2022 and is currently available for public use. Our Tool Kit can be downloaded for free here: https://tinyurl.com/yey9hjpa Citation Format: Carolina Aristizabal, Fern Webb, Sandra Suther, Eduardo Ibarra, Cynthia Quince, Rosa Barahona, Mariana C. Stern, Lourdes A. Baezconde-Garbanati. Addressing cancer clinical trials lack of enrollment among African Americans and African Nationals [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr B016.