Inclusion and diversity in clinical trials: Actionable steps to drive lasting change

Kelsey, Michelle D; Patrick-Lake, Bray; Abdulai, Raolat M.; Broedl, Uli C.; Brown, Adam; Cohn, Elizabeth; Curtis, Lesley H.; Komelasky, Chris; Mbagwu, Michael; Mensah, George A.; Mentz, Robert J.; Nyaku, Amesika; Omokaro, Stephanie O.; Sewards, Judy; Whitlock, Kendal; Zhang, Xinzhi; Bloomfield, Gerald S.

doi:10.1016/j.cct.2022.106740

Cited by 81 publications

(53 citation statements)

References 32 publications

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“…67 Such concerns may, in part, be mitigated by efforts such as the NIH Revitalization Act of 1993, the FDA's Drug Trials Snapshots Program, and the FDA's recent push for clinical trial sponsors to include diversity plans in clinical trial applications. 68,69 We hope this study encourages the scientific community to improve efforts to collect specimens from diverse populations irrespective of race, ethnicity, and socioeconomic status, perform inclusivity analyses as part of routine demographics analyses, and consider incorporation of molecular diagnostic testing into routine care. Collectively, these efforts would increase representation of real-world patient populations in genomics databases, which may enable more equitable representation in research studies and advance personalized care for all patients with cancer.…”

Section: Discussionmentioning

confidence: 99%

Comparison of PIK3CA Mutation Prevalence in Breast Cancer Across Predicted Ancestry Populations

Chen¹,

Murugesan²,

Newberg³

et al. 2022

JCO Precision Oncology

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PURPOSE Understanding the differences in biomarker prevalence that may exist among diverse populations is invaluable to accurately forecast biomarker-driven clinical trial enrollment metrics and to advance inclusive research and health equity. This study evaluated the frequency and types of PIK3CA mutations ( PIK3CAmut) detected in predicted genetic ancestry subgroups across breast cancer (BC) subtypes. METHODS Analyses were conducted using real-world genomic data from adult patients with BC treated in an academic or community setting in the United States and whose tumor tissue was submitted for comprehensive genomic profiling. RESULTS Of 36,151 patients with BC (median age, 58 years; 99% female), the breakdown by predicted genetic ancestry was 75% European, 14% African, 6% Central/South American, 3% East Asian, and 1% South Asian. We demonstrated that patients of African ancestry are less likely to have tumors that harbor PIK3CAmut compared with patients of European ancestry with estrogen receptor–positive/human epidermal growth factor receptor 2–negative (ER+/HER2–) BC (37% [949/2,593] v 44% [7,706/17,637]; q = 4.39E-11) and triple-negative breast cancer (8% [179/2,199] v 14% [991/7,072]; q = 6.07E-13). Moreover, we found that PIK3CAmut were predominantly composed of hotspot mutations, of which mutations at H1047 were the most prevalent across BC subtypes (35%-41% ER+/HER2– BC; 43%-61% HER2+ BC; 40%-59% triple-negative breast cancer). CONCLUSION This analysis established that tumor PIK3CAmut prevalence can differ among predicted genetic ancestries across BC subtypes on the basis of the largest comprehensive genomic profiling data set of patients with cancer treated in the United States. This study highlights the need for equitable representation in research studies, which is imperative to ensuring better health outcomes for all.

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Section: Discussionmentioning

confidence: 99%

Comparison of PIK3CA Mutation Prevalence in Breast Cancer Across Predicted Ancestry Populations

Chen¹,

Murugesan²,

Newberg³

et al. 2022

JCO Precision Oncology

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“…Recent guidance from the FDA [85] and funders such as the UK's NIHR launched the INCLUDE ethnicity framework and toolkit in 2020 [86] detailing more inclusive trial enrolment practices. While much is focused on steps to improve diversity of participants in clinical trials [87], those principles and approaches should be adopted in end-to-end PE practices, process, and organisational alignment towards them. It seems logical that the greatest chance of the success of a clinical development programme (from development to patient and population health improvements) is to have the bidirectional engagement, education and partnership with the patient communities that are likely to benefit the most from the innovation being developed.…”

Section: Broadening Inclusivity In Clinical Research and Pementioning

confidence: 99%

Using Patient Perspectives to Inform Better Clinical Trial Design and Conduct: Current Trends and Future Directions

Faulkner¹,

Somers²,

Boudes³

et al. 2023

Pharm Med

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The approach to patient engagement (PE) in drug development has changed rapidly due to many factors, including the complexity of innovative drugs and the need to demonstrate outcomes of relevance to patients, the desire to show ‘value add’ of PE, and the pandemic-related changes to how clinical trials are run, e.g., decentralised studies. In parallel, there have been changes in technology-assisted ways of running clinical trials, capturing patient health outcomes and preferences, an increasing societal demand for diversity and inclusion, and efforts to improve clinical trial efficiency, transparency, and accountability. Organisations are beginning to monitor PE activities and outcomes more effectively to learn and inform future PE strategies. As a result, these factors are facilitating the incorporation of patients’ lived experience, preferences and needs into the design and running of clinical trials more than ever before. In this paper, the authors reflect upon these last few years, the emerging trends and their drivers, and where we may expect PE in clinical research to progress in the near future.

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“…28 Solutions often remain theoretical and large-scale, such as countering community mistrust stemming from historical atrocities, leveraging community engagement between the government and research institutions, or expanding clinical research operations outside of academic medical center clusters. 14,29,30 Further, recent regulatory guidance, such as the FDA's guidance on "Enhancing the Diversity of Clinical Trial Populations…" and "Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials" present actions as recommendations rather than requirements. 3 Whereas the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act was introduced in February 2022 as legislation requiring more stringent race and ethnicity reporting as well as a required Diversity Action Plan, the DEPICT Act remains unapproved as of December 2022.…”

Section: Articlementioning

confidence: 99%

Clinical Trial Site Perspectives and Practices on Study Participant Diversity and Inclusion

MacLennan

Plahovinsak

MacLennan

et al. 2023

Clin Pharma and Therapeutics

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Clinical trial participant populations fail to adequately represent target populations that drugs are intended to serve. Improving racial and ethnic diversity of clinical trial participants is essential for generalizable, quality clinical research results and ensuring social and medical equity. Site-level clinical research professionals (CRPs) have unique insights on diversity improvement strategies for clinical trial enrollment. A survey was distributed to current CRPs working at clinical research sites in the United States to describe current practices and perceptions of the impact these practices have on participant diversity. Subsequently, descriptive quantitative analysis and inductive content analysis were performed. For the practices surveyed, there are discrepancies between frequency of use and perceived impact on diversity enrollment. Common current practices include phone-based or telemedicine study visits, electronic/digital data collection, and participant compensation. However, we report travel reimbursement and services, translated documents and translator services, and adequate participant compensation as most impactful on diverse enrollment. A multistakeholder approach is necessary to enhance diversity and inclusion (D&I) of study participants. Besides large-scale solutions such as countering community distrust, actionable steps are needed by sponsors and study sites to improve D&I of trial participants. Study leadership at the sponsor, contract research organization (CRO), and site-level should create diversity plans prior to study start, and CRO and sponsor budgets should consider D&I strategies during study planning. Planning should incorporate strategies to improve D&I including adequate participant compensation, translated documents and translator services, and travel reimbursements.

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Inclusion and diversity in clinical trials: Actionable steps to drive lasting change

Cited by 81 publications

References 32 publications

Comparison of PIK3CA Mutation Prevalence in Breast Cancer Across Predicted Ancestry Populations

Comparison of PIK3CA Mutation Prevalence in Breast Cancer Across Predicted Ancestry Populations

Using Patient Perspectives to Inform Better Clinical Trial Design and Conduct: Current Trends and Future Directions

Clinical Trial Site Perspectives and Practices on Study Participant Diversity and Inclusion

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