Disparate inclusion of older adults in clinical trials: priorities and opportunities for policy and practice change.
Older adults are vastly underrepresented in clinical trials in spite of shouldering a disproportionate burden of disease and consumption of prescription drugs and therapies, restricting treatments' generalizability, efficacy, and safety. Eliminating Disparities in Clinical Trials, a national initiative comprising a stakeholder network of researchers, community advocates, policymakers, and federal representatives, undertook a critical analysis of older adults' structural barriers to clinical trial participation. We present practice and policy change recommendations emerging from this process and their rationale, which spanned multiple themes: (1) decision making with cognitively impaired patients; (2) pharmacokinetic differences and physiological age; (3) health literacy, communication, and aging; (4) geriatric training; (5) federal monitoring and accountability; (6) clinical trial costs; and (7) cumulative effects of aging and ethnicity.
The University of Texas MD Anderson Cancer Center, Houston, TX, USA. apherrera@ucsd.edu
Angelica P
AP
Herrera
Shedra Amy
SA
Snipes
Denae W
DW
King
Isabel
I
Torres-Vigil
Daniel S
DS
Goldberg
Armin D
AD
Weinberg
D000368:Aged; D015982:Bias; D002985:Clinical Protocols / Q000592:standards; D002986:Clinical Trials as Topic; D006801:Humans; D018579:Patient Selection; D011050:Policy Making; D014481:United States; D014486:United States Food and Drug Administration