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 ...

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 ...

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 ...

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 ...

As compared to conventional, stand-alone clinical trials in advanced non-small cell lung cancer (NSCLC), the biomarker-driven Lung Cancer Master Protocol (Lung-MAP) has enrolled higher percentages of ...

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance, “Master Protocols for Drug and Biological Product Development”, that echoes and builds on principles that the Agency ...

SJ: Amgen has been doing innovative trial designs for well over 5-6 years. We incorporate innovative designs in probably at least 70-80% of our protocols. The therapeutic area where we use them the ...