The European Forum for Good Clinical Practice (EFGCP) Children’s Medicines Working Party (CMWP) has developed an open-access “Adolescent Inclusion Decision Tree” to be used by trial sponsors, trial investigators, IRBs/ethics committees, and health regulatory agencies, when a trial with age-inclusive trial design is being explored, developed or reviewed.
The tool outlines over-arching principles for consideration, and guides users through 5 categories to ascertain the appropriateness of the clinical trial for adolescent inclusion: (1) disease, (2) product, (3) statistical, (4) operational, and (5) legal & ethical.
This tool, which will be updated periodically, is intended to provide a general framework upon which trial sponsors, investigators, health agencies, and/or ethics committees can systematically and reliably evaluate areas of potential conflict within the development of the trial protocol and engage in robust conversation on the appropriateness of adolescent inclusion in relevant adult trials.
The “Adolescent Inclusion Decision Tree” is available here.