21 March 2016 - In the November 10, 2015 issue of Journal of Clinical Oncology, the American Society of Clinical Oncology released a series of recommendations (by Hurria et al) to improve the generation of evidence in older adults with cancer. The authors cited an aging US population, underrepresentation of older adults in clinical research, and a lack of evidence in older adults about the quality of care.

The third recommendation calls on the US Food and Drug Administration (FDA) to incentivize and require research that includes older adults. The article correctly acknowledges the limited authority of the FDA and encourages additional data gathering and recommendations on safety, efficacy, and dosing in older adults.

The FDA recognizes this issue and, in 2014, released the report, FDA Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data. One priority stated in the report is to make demographic data from clinical trials more available and transparent. To help achieve this priority, the FDA implemented an initiative called Drug Trials Snapshots. Aimed at increasing transparency, Snapshots provide two general areas of information: who participated in clinical trials, by age, sex, and ethnicity; and descriptions of any differences in efficacy and safety among subgroups. As of January 1, 2015, a Snapshot is written and published for every approved new molecular entity and original biologic product.

For more details, go to: http://jco.ascopubs.org/content/early/2016/03/17/JCO.2015.64.7099?cmpid=jco_pap_21Mar2016