Rapid, uncoordinated growth has turned the PD-1/L1 inhibitor pipeline into a global stampede, FDA’s Pazdur and Beaver say. Solutions like a unified submission pathway and coordinated trial design pose challenges requiring international cooperation among governments and industry alike.
International regulatory coordination toward a “unified regulatory submission pathway” for immuno-oncology drugs could foster more rational use of resources, two FDA Oncology Center of Excellence officials propose in the New England Journal of Medicine – but they note that the US FDA lacks the ability to enforce changes unilaterally.
The “unbridled and rapid growth” of the PD-1/L1 inhibitor class has resulted in “a stampede of commercial sponsors, clinical trials...
The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.
Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.
The UK government is making it easier for millions of people to participate in clinical trials and is boosting transparency around how studies are delivered across the National Health Service.
The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.
