FDA issued three draft guidance documents on eligibility criteria in cancer clinical trials to address performance status, washout periods and concomitant medications, and laboratory values.
NIH announced Jan. 29 that “Basic Experimental Studies Involving Humans,” also called BESH, will no longer be considered clinical trials and will therefore no longer be subject to the requirements under the NIH definition of a clinical trial, including registration and reporting requirements in ClinicalTrials.gov.
