The External Controls Draft Guidance provides FDA’s thinking specifically with regard to a trial that has a single treatment arm and single control arm. The draft guidance proposes that in addition to ...

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 ...

IMblaze370 evaluated atezolizumab with or without cobimetinib versus regorafenib in patients with mCRC. EC arms were constructed from the Flatiron Health (FH) EHR-derived de-identified database and ...

We all get tempted away from the task at hand. Who resists this temptation? Does external control help us resist temptation? How well we resist temptation and the effects of external control depend on ...

In 1954, Psychologist Julian B. Rotter proposed the concept of locus of control made up of two ends of a continuum. On one end of the continuum is the internal locus of control with the external locus ...

Control arms in randomized clinical trials (RCTs) have a key role in isolating the effects of the medical product from those caused by other factors. However, in some cases — such as phase II trials ...

As Mother Teresa famously said, "To work without love is slavery." She was speaking about those who work without satisfaction and pleasure. According to Gallup's State of the Global Workplace report, ...