The External Controls Draft Guidance provides FDA’s thinking specifically with regard to a trial that has a single treatment arm and single control arm. The draft guidance proposes that in addition to ...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