The External Controls Draft Guidance provides FDA’s thinking specifically with regard to a trial that has a single treatment arm and single control arm. The draft guidance proposes that in addition to ...

Advances in genomics have enabled anticancer therapies to be tailored to target specific genomic alterations. Single-arm trials (SATs), including those incorporated within umbrella, basket, and ...

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 ...

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 ...

Results from single-arm clinical trials can be contextualized by comparing against external controls (ECs) derived from real-world data (RWD). However, lack of randomization and differences in ...

Delandistrogene moxeparvovec showed significant long-term stabilization or slowed progression in DMD patients over 3 and 5 years compared to external controls. Clinical trials demonstrated ...

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 ...