The External Controls Draft Guidance provides FDA’s thinking specifically with regard to a trial that has a single treatment arm and single control arm. The draft guidance proposes that in addition to ...
(Nanowerk Spotlight) Controlling how electromagnetic waves behave as they move through space is essential for technologies like wireless communication, radar, and remote sensing. Engineers have ...
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 ...
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 ...
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 ...
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 ...
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