A recent opinion piece in the New England Journal of Medicine discusses a European strategy for appropriate research, marketing, and authorization for geriatric medicines. The article identifies some policies and practices to address the fact that clinical drug trials may not provide sufficient evidence for the use of drugs by older patients, and that standards for drug education and packaging may not be adequate for the needs of many older adults.
As discussed previously in aging in action, clinical drug trials overwhelmingly do not include representative samples of older adults. This is true in the sense that older adults make up a disproportionately small percentage of clinical trial participants, despite being the largest group of users of medication, and in the sense that older adults who are included in clinical trials are significantly healthier and younger than the general older adult population. This is a problem because safety and clinical guidelines are based on how participants respond to drug trials, which then may not provide adequate information about how drugs affect older adult patients.
The authors point to the irony that older adults are often considered a “specialty” subpopulation in pharmaceutical research, despite being the largest group of medication users. There are legitimate concerns about how appropriate existing clinical research data are for older and frailer patients.
A few strategies suggested by the authors include the development of a consensus definition of frailty that can be used in place of chronological age for identifying who to enroll in clinical trials, and increased inclusion of drug study participants who use other common medications. These strategies would allow clinical trials to be more representative of the population of medicine users and encourage the positive trend against setting unjustified age limits on research participants.
The authors also address the need for drug dosage, design, and packaging to be conducive for older patients, who may struggle with drug compliance due to memory, visual, and motor impairments.