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Comment & Response |

Underrepresentation of Older Adults in Cancer Trials

Jing Luo, MD1; Aaron S. Kesselheim, MD, JD, MPH2
[+] Author Affiliations
1Yale Primary Care Internal Medicine Residency Program, Yale School of Medicine, New Haven, Connecticut
2Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital, Boston, Massachusetts
JAMA. 2014;311(9):965-966. doi:10.1001/jama.2013.286454.
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To the Editor We share the concern expressed by Dr Hurria and colleagues1 in their Viewpoint regarding the underrepresentation of older adults in cancer trials submitted for registration with the US Food and Drug Administration (FDA). We disagree with the Institute of Medicine’s (IOM) recommendation to “amend patent law to provide patent extensions of up to six months for companies that conduct clinical trials”2 in this population. The Pediatric Research Equity Act, which provides 6 months of market exclusivity for manufacturers that study their products in children and which serves as the basis for this recommendation, has a more complex legacy than Hurria et al1 acknowledged.

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March 5, 2014
Harvey Jay Cohen, MD; Mary Naylor, PhD, RN; Arti Hurria, MD
1Center for the Study of Aging and Human Development, Duke University Medical Center, Durham, North Carolina
2New Cortland Center for Transitions and Health, University of Pennsylvania School of Nursing, Philadelphia
3City of Hope Comprehensive Cancer Center, Duarte, California
JAMA. 2014;311(9):966-967. doi:10.1001/jama.2013.286457.
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