In an article published Thursday in the New England Journal of Medicine, two top officials from the US Food and Drug Administration (FDA) say that "master protocols" for studies involving multiple ...

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 ...

Why do you believe master protocols are so important to the future of clinical research? A master protocol approach can provide inferential benefits and operational efficiency. Clinical development is ...

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance, “Master Protocols for Drug and Biological Product Development”, that echoes and builds on principles that the Agency ...

Timing of Adjuvant Chemotherapy After Gastrectomy in Patients With Stage II to III Gastric Cancer: A Target Trial Emulation Study Master protocols represent transformations, enabling multiple ...

The US Food and Drug Administration (FDA) has issued new guidance describing its current recommendations with respect to master protocols for the evaluation of drugs and biologics to treat or prevent ...

Bortezomib, lenalidomide, and dexamethasone (VRd) ± daratumumab (DARA) in patients (pts) with newly diagnosed multiple myeloma (NDMM) for whom transplant is not planned as initial therapy: A ...