FDA has issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice,” which, when finalized, will support the conduct of randomized controlled trials with streamlined protocols and procedures that focus on essential data collection, allowing integration of research into routine clinical practice.
A group of melanoma experts, joined by three advocacy groups focused on melanoma, has engaged FDA in a public discussion of the challenges of developing new drugs in the refractory setting and the role crossover can play in such trials.
