FDA removes black box warnings for most MHT products, reflecting evidence that breast cancer risk varies by formulation, ...

Covariate-adaptive randomization represents an advanced methodology in the design of clinical trials, ensuring a balanced distribution of prognostic factors among treatment groups. This approach ...

An expert from the FDA explained the benefits and limitations of these two clinical trial formats and how the cancer field can learn from both. The use of single-arm trials, in which all patients ...