Elderly Representation In Clinical Trials: Not A Gray Area

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:

• Trial participants should be representative of the patient population receiving the therapy in daily medical practice.
• People over age 65 make up the majority of patients for many medications treating chronic conditions.
• The over-65 segment is the fastest growing segment of the world's population. By 2050, the number of people ages 65+ will be 16 percent of the global total, up from 5 percent in 1950

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.