Workshop on Designing Clinical Trials for Age-Related Functional Decline
Join the Aging Initiative and the Boston Pepper Center on November 20th at 6:30-8:30pm at Harvard College for an exclusive workshop on the future of clinical trial design for new therapeutics addressing key aspects of aging, emphasizing academia-industry collaborations. The event will be led by Dr Bhasin, the author of the TRAVERSE trial and a world-leading expert in clinical trials for function-promoting therapies in older adults. The event will serve to catalyze discussion in designing pivotal trials for new medicines addressing age-related functional decline and is open to clinicians, industry professionals, researchers as well as medical, graduate and undergraduate students.
Developing therapeutics to address functional decline in aging is highly desirable, but validating their clinical efficacy and attaining regulatory approval requires a Phase 3 pivotal trial. Lifespan-extension trials are cost-prohibitive owing to a low mortality event frequency, requiring large cohorts and potentially decades-long follow-up. Trials addressing multimorbidity (disease incidence, composite hard endpoints) appear to be the way forward; yet, choosing the specific endpoints, patient population and therapeutic indication to demonstrate efficacy and attain regulatory approval remains challenging. Addressing this challenge is a key requirement to enable development of broadly applicable function-promoting therapeutics.
The Boston Pepper Center is the leading group of clinical researchers in Boston conducting translational studies with the goal of developing function-promoting therapies, having performed some of the largest cardiovascular outcome and frailty-related trials. The TRAVERSE trial of testosterone in older adults, led by Pepper Center Director Dr Shalender Bhasin, offers a concrete case study. It incorporates composite measures like cardiovascular outcomes, fractures, diabetes incidence, mental well-being and beyond across over 5,000 patients, serving as a template for a function-promoting therapeutic trial.