title: A New Ethical Challenge for Institutional Review Boards (IRBs)/Ethics Committees (ECs) in the Assessment of Pediatric Clinical Trials.
abstract: Both the US and EU have introduced pediatric pharmaceutical legislation to facilitate clinical trials in children and development of better medicines for children. The first concerns were published in 2014 that the European Medicines Agency (EMA)'s Pediatric Committee (PDCO) may be over-enthusiastic and has compelled questionable pediatric clinical trials from pharmaceutical companies. Numerous clinical trials are mandated in rare conditions for which not enough patients exist for even one trial. Furthermore, where these trials are mandated in adolescent patients, the legal age limit of the 18th birthday is confused with a medical age limit and can result in separate clinical trials in adolescent patients that neither make medical nor scientific sense nor will ever recruit enough patients for a meaningful outcome. To confirm our concerns we searched the registry clinicaltrials.gov and found examples for PDCO-triggered unethical trials. We conclude that such trials should not be accepted by institutional review boards (IRBs)/ethics committees (ECs) and that clinical trials resulting from negotiations with EMA's PDCO need extra careful scrutiny by IRBs/ECs in order to prevent unethical studies and damage to pediatric research and unnecessary risks to pediatric patients.
authors.affiliation: Consulting, Pediatric Drug Development &#38; More, Aeussere Baselstrasse 308, 4125 Riehen, Switzerland. klaus.rose@klausrose.net.
authors.forename: Klaus
authors.initials: K
authors.lastname: Rose
authors.affiliation: University of Basel, Im Kirsgarten 57, 4106 Therwil, Basel-Landschaft, Switzerland. hmkummer@bluewin.com.
authors.forename: Hans
authors.initials: H
authors.lastname: Kummer
keywords: Better Medicines for Children; Ethics Committee (EC); Institutional Review Board (IRB); ethical clinical trials; ethics; ghost studies; pediatric drug development; therapeutic hostages; therapeutic orphans; unethical clinical trials