Age-based disparities in clinical trials: Barriers and multi-level policy solutions

Background: Clinical trials offer important therapeutic options and test the safety and efficacy of new treatments. Equal access to clinical trials by diverse populations ensures a treatment's generalizability or limitations. Older adults are vastly underrepresented in clinical trials in spite of suffering the greatest burden of ill health, spending 36% of total personal healthcare dollars, and consuming 34% of all prescriptions. Objectives: We reviewed older adults' and minority elders' individual, community, and system-level barriers to clinical trial participation, identified weaknesses in existing health policies, and explored opportunities for policy-driven change to increase elders' clinical trial participation and retention. Methods: The Policy Research arm of the Eliminating Disparities in Clinical Trials (EDICT) initiative has nine cross-disciplinary teams of policy experts, federal agents, community advocates, academics, and clinical researchers. The teams convene at national meetings and ongoing Web-based teleconferences to devise practical solutions to clinical trial disparities across racial/ethnic, gender, and age groups. Results: The EDICT project has winnowed and deliberated over policies that address: (a) study design modifications and clinical trial eligibility criteria, (b) age-friendly approaches to health illiteracy and seniors' social support needs, (c) the FDA's Guidance for the Industry and geriatric use labeling, (d) NIH oversight, monitoring, and enforcement, (e) the ethics of informed consent with cognitively impaired older adults, (f) Medicare coverage of clinical trials, and (g) requirements in medical and pharmacy education to reduce ageism. Conclusion: The proposed policy changes offer promising solutions to significantly diminish age-based disparities in clinical trials at multiple levels.