Those of use who are involved in the care of the elderly often question whether we can apply the results of clinical trials to our patients. We know that organ function typically declines with age, making them more susceptible to adverse reactions. They typically use more medications, increasing the likelihood of drug interactions.
I have been monitoring this issue for several decades. Several studies seem to support the fact that the elderly are misrepresented in clinical trials.
An analysis of the Food and Drug Administration database looked at the initial documents submitted by manufacturers for approval. A majority of the documents did include pharmacokinetic data in the elderly (62%); however, information on safety (42%) and efficacy (45%) was less available. This trend has not improved over time.
Ruiter R, Burggraaf J, Rissmann R. Under-representation of elderly in clinical trials: An analysis of the initial approval documents in the Food and Drug Administration database. Br J Clin Pharmacol. 2019 Apr;85(4):838-844. doi: 10.1111/bcp.13876.
Even though cancer disproportionately affects the elderly population, they are typically under-represented in trials. The Southwest Oncology Group only enrolled 25% of their population >65 years. Barriers cited were concerns about treatment tolerance, drug metabolism, quality of life and logistics. Overcoming these barriers may improve the treatment options for these patients.
Denson AC, Mahipal A. Participation of the elderly population in clinical trials: barriers and solutions. Cancer Control. 2014 Jul;21(3):209-14. doi: 10.1177/107327481402100305.
A cross-sectional analysis of 80,965 registered interventional clinical trials found that only 1.4% of them focused on the elderly. Most studies were small (median sample size 122 participants) and single-center (67%).
Bourgeois FT, Olson KL, Tse T, Ioannidis JP, Mandl KD. Prevalence and Characteristics of Interventional Trials Conducted Exclusively in Elderly Persons: A Cross-Sectional Analysis of Registered Clinical Trials. PLoS One. 2016 May 19;11(5):e0155948. doi: 10.1371/journal.pone.0155948.
Until we have better representation of older adults in clinical trials, drug therapy selection should be approached with special consideration of risk/benefit analysis and a recognition that lower starting dosages are almost always the safest course of action.
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