FDA approvals for pediatric cancer indications using children’s oncology group associated trials data
Margaret E. Macy·Douglas S. Hawkins·Brenda J Weigel·Jennifer H. Foster·Thalia Beeles·Mary Beth Sullivan·Nicole D. Towcimak·L. Gore·Malcolm A. Smith·Elizabeth Fox
Almost half of FDA approved pediatric indications for oncology therapeutics were supported by data from COG trials, highlighting the effectiveness of this public-private partnership model in producing the level of clinical evidence required for regulatory success.
