Using master protocols in pediatric clinical trials could speed the development of drugs for pediatric indications that already have development programs for adults, according to a recent paper written by industry representatives and published in Therapeutic Innovation & Regulatory Science.
A master protocol framework would potentially have “great benefit” because stakeholders could use shared control groups, operate more efficiently in the clinical setting and use Bayesian analysis to assess primary outcomes with a lower the number of enrolled participants, Robert M. Nelson, MD PhD, of Johnson & Johnson, and co-authors from Janssen Research & Development and Eli Lilly and Company, said.
The pediatrics space has seen little use of master protocols—usually in pediatric oncology, in rare, and ultra-rare diseases. However, master protocols could be applicable in other situations where clinical trials are conducted in small pediatric populations, they argued…
