Current State and Future Improvement of the Elderly Participation in Clinical Trials

Abstract

Background: Clinical trials are widely used to approve the efficacy and discover adverse reactions of new drugs. However, there has been much concern about the unjustified exclusion of the older adults in clinical trials. The purpose of this study was to assess ageism in clinical trials and to find solution to any discovered discrimination. Methods: An online questionnaire was completed by 1,650 experts including doctors, pharmaceutical staff, and contract research organization members. An offline inquiry was conducted by 250 experienced professors from a single tertiary hospital and other allied professions. The questions covered the current state of elderly participation, possible reasons for under-representation, and plans for its solution. Results: Among 1,900 subjects, 246 (12.9%) individuals completed the survey. We excluded the six subjects who did not answer more than 10 questions, and analyzed the remaining 240 respondents. They agreed that there are tendencies to exclude the aged from clinical trials (69.2%), and that under-representation would cause difficulties for doctors and geriatric patients. Most people (84.6%) thought that treating older adults with the results from trials which exclude aged participants is inappropriate. Because respondents had difficulties explaining the trial process and obtaining informed consent, they thought establishing a geriatric clinical trial team would be highly effective. Experts also believed that financial inducements and legal regulations are required to increase elderly enrollment. Conclusion: Because the elderly have a unique physiology, the participation of older adults in clinical research is indispensable for verifying efficacy and determining potential adverse reactions. Consequently, clinical research professionals should be concerned about the participation of older subjects, and the authorities must begin to care about age discrimination in research fields.