Trial Design

EMA Clarifies Requirements for Heart Failure Studies

The European Medicines Agency released final guidance June 10 on the primary and secondary endpoints sponsors should use to evaluate drugs to treat acute heart failure — along with recommendations on designing and conducting such studies in children. Read More

FDA Finalizes Guidance on CGT Early-Stage Trials

Because cellular and gene therapy products can have more severe effects than other types of drug products, potentially leading to organ failure, tumors or death, sponsors should include these as primary safety objectives when designing early-phase clinical trials, the FDA says. Read More