The External Controls Draft Guidance provides FDA’s thinking specifically with regard to a trial that has a single treatment arm and single control arm. The draft guidance proposes that in addition to ...

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 ...

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 ...

In 1954, psychologist Julian B. Rotter proposed the concept of locus of control. He said it contained two ends of a continuum. On one end of the continuum is the internal locus of control. On the ...

This is the second article in Microbiologics’ series on Optimal QC in the Clinical Laboratory. In a previous article, we highlighted the importance of external quality control products for QC in the ...