Disparate Inclusion of Older Adults in Clinical Trials: Priorities and Opportunities for Policy and Practice Change

Overview

Journal Am J Public Health

Specialty Public Health

Date 2010 Feb 12

PMID 20147682

Citations 135

Authors

Angelica P Herrera

Shedra Amy Snipes

Denae W King

Isabel Torres-Vigil

Daniel S Goldberg

Armin D Weinberg

Affiliations

Soon will be listed here.

Abstract

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.

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References

Heiat A, Gross C, Krumholz H . Representation of the elderly, women, and minorities in heart failure clinical trials. Arch Intern Med. 2002; 162(15):1682-8. DOI: 10.1001/archinte.162.15.1682. View

Stahl S, Hahn A . The Resource Centers for Minority Aging Research (RCMAR): community/researcher interaction and relationships. Ethn Dis. 2007; 17(1 Suppl 1):S1-2. View

Golden T, Hubbard A, Dando C, Herren M, Melov S . Age-related behaviors have distinct transcriptional profiles in Caenorhabditis elegans. Aging Cell. 2008; 7(6):850-65. PMC: 2613281. DOI: 10.1111/j.1474-9726.2008.00433.x. View

Palmer B, Dunn L, Appelbaum P, Mudaliar S, Thal L, Henry R . Assessment of capacity to consent to research among older persons with schizophrenia, Alzheimer disease, or diabetes mellitus: comparison of a 3-item questionnaire with a comprehensive standardized capacity instrument. Arch Gen Psychiatry. 2005; 62(7):726-33. DOI: 10.1001/archpsyc.62.7.726. View

Townsley C, Chan K, Pond G, Marquez C, Siu L, Straus S . Understanding the attitudes of the elderly towards enrolment into cancer clinical trials. BMC Cancer. 2006; 6:34. PMC: 1382233. DOI: 10.1186/1471-2407-6-34. View

Souder J . The consumer approach to recruitment of elder subjects. Nurs Res. 1992; 41(5):314-6. View

Long J, Chang V, Ibrahim S, Asch D . Update on the health disparities literature. Ann Intern Med. 2004; 141(10):805-12. DOI: 10.7326/0003-4819-141-10-200411160-00013. View

Pugh M, Hanlon J, Zeber J, Bierman A, Cornell J, Berlowitz D . Assessing potentially inappropriate prescribing in the elderly Veterans Affairs population using the HEDIS 2006 quality measure. J Manag Care Pharm. 2006; 12(7):537-45. PMC: 10437888. DOI: 10.18553/jmcp.2006.12.7.537. View

Marroum P, Gobburu J . The product label: how pharmacokinetics and pharmacodynamics reach the prescriber. Clin Pharmacokinet. 2002; 41(3):161-9. DOI: 10.2165/00003088-200241030-00001. View

10.

Schron E, Wassertheil-Smoller S, Pressel S . Clinical trial participant satisfaction: survey of SHEP enrollees. SHEP Cooperative Research Group. Systolic Hypertension in the Elderly Program. J Am Geriatr Soc. 1997; 45(8):934-8. DOI: 10.1111/j.1532-5415.1997.tb02962.x. View

11.

Jeste D, Palmer B, Appelbaum P, Golshan S, Glorioso D, Dunn L . A new brief instrument for assessing decisional capacity for clinical research. Arch Gen Psychiatry. 2007; 64(8):966-74. DOI: 10.1001/archpsyc.64.8.966. View

12.

Hutchins L, Unger J, Crowley J, COLTMAN Jr C, Albain K . Underrepresentation of patients 65 years of age or older in cancer-treatment trials. N Engl J Med. 1999; 341(27):2061-7. DOI: 10.1056/NEJM199912303412706. View

13.

. Health disparities experienced by Hispanics--United States. MMWR Morb Mortal Wkly Rep. 2004; 53(40):935-7. View

14.

Ramirez A, Wildes K, Talavera G, Napoles-Springer A, Gallion K, Perez-Stable E . Clinical trials attitudes and practices of Latino physicians. Contemp Clin Trials. 2007; 29(4):482-92. PMC: 2587358. DOI: 10.1016/j.cct.2007.11.001. View

15.

Yancey A, Ortega A, Kumanyika S . Effective recruitment and retention of minority research participants. Annu Rev Public Health. 2006; 27:1-28. DOI: 10.1146/annurev.publhealth.27.021405.102113. View

16.

Beglinger C . Ethics related to drug therapy in the elderly. Dig Dis. 2008; 26(1):28-31. DOI: 10.1159/000109382. View

17.

Trimble E . Concluding remarks: optimal treatment for women with ovarian cancer. Semin Oncol. 2007; 33(6 Suppl 12):S25-6. DOI: 10.1053/j.seminoncol.2006.11.004. View

18.

Turnheim K . When drug therapy gets old: pharmacokinetics and pharmacodynamics in the elderly. Exp Gerontol. 2003; 38(8):843-53. DOI: 10.1016/s0531-5565(03)00133-5. View

19.

Moreno-John G, Fleming C, Ford M, Lichtenberg P, Mangione C, Perez-Stable E . Mentoring in community-based participatory research: the RCMAR experience. Ethn Dis. 2007; 17(1 Suppl 1):S33-43. View

20.

Thompson L, Gallagher D, Nies G, Epstein D . Evaluation of the effectiveness of professionals and nonprofessionals as instructors of "coping with depression" classes for elders. Gerontologist. 1983; 23(4):390-6. DOI: 10.1093/geront/23.4.390. View