By Simonetta Alvino, M.D., Senior Medical Director, INC Research/inVentiv Health
Typically, clinical trials conducted in adult populations include patients between the ages of 18 and 65. This is a broad range, but arguably no longer broad enough. In most therapeutic categories, this upper age cutoff is too low, given that:
Regulators have, in fact, offered guidance on the subject, stating that study participants should be representative of the patient population and that protocols should not set an arbitrary upper age limit.