'Although sponsors have conventionally focused on the development of a drug, the strategy of pursuing site-agnostic indications must focus on both drug and biomarker development,' FDA's Richard Pazdur and colleagues write in the New England Journal of Medicine.
The US FDA is advising sponsors to carefully consider the appropriateness for developing drugs across tumor types and to work collaboratively on biomarkers in the wake of the groundbreaking approval of Merck & Co. Inc.'s Keytruda for a "tissue-agnostic" indication.
Merck's PD-1 inhibitor Keytruda (pembrolizumab) won accelerated approval in May for any type of solid tumor that are microsatellite-high (MSI-H)...
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.
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.
A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges
