While recent FDA guidance speaks to the agency’s support of innovative trial designs—including the use of external ...

Many assays have integrated, built-in, or internal controls to demonstrate their operability at specific procedural steps. What role do these built-in controls play in quality control to assure ...

Clinical trials give patients hope — especially when all other available treatments have been exhausted. That hope compels patients to commit a substantial amount of time and effort for the chance to ...

To inform continued development of the novel immune agent GEN-1, we compared ovarian cancer patients' end points from a neoadjuvant single-arm phase IB study with those of similar historic clinical ...

Final meeting minutes rejected the external-control strategy for AMT-130 and recommended a prospective, randomized, double-blind, sham surgery-controlled confirmatory study. Agency rationale ...