Inclusion of older people in interventional clinical trials

Author(s): Prabhath Fernando, Amit Arora, Peter Crome

The population growth and demographic changes have been remarkable in the past century, leading to a massive growth in the older population. Older people constitute the largest group of consumers of medications globally and will continue to be so for the foreseeable future. There has been chronic and unjustifiable underrepresentation of older people in interventional clinical trials, as has been evident in the majority of landmark studies that have been designed to address questions very pertinent to older people as well in many different medical specialties. Chronological age itself or comorbidity, or both in combination, have been instrumental directly or indirectly for systematic exclusion of older people from these clinical trials. Hence the evidence base for treating older people with medical conditions that usually tend to coexist in a given older person is rather patchy and dubious, leading to speculation of benefit from interventions as a result of extrapolation of inferences from trials in younger populations and also placing older people at risk of harm from dreadful adverse effects of medications of which the benefits for them are unproven. There are many expressed and unexpressed reasons for existence of direct and indirect age discrimination in interventional clinical trials. Researchers and pharmaceutical companies along with inertia of research ethic committees and professional bodies, which play a role of advocacy for older people, will have to share the blame and responsibility for the current state of deplorable affairs pertinent to medical research in older people. Answers to the lack of enthusiasm for including older people in clinical trials would be many, but will definitely involve changes in the attitudes of researchers. It will also require enforcement of legislations for proportional representation of older people in clinical trials in keeping with incidence and prevalence of diseases amongst them.