The External Controls Draft Guidance provides FDA’s thinking specifically with regard to a trial that has a single treatment arm and single control arm. The draft guidance proposes that in addition to ...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 ...
Racial Disparities in Receipt of Guideline-Concordant Care for Early-Onset Colorectal Cancer: We Must Do Better The treatment options for children with brain tumors are limited, and more clinical ...
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 ...
Investigational RGX-202 continues to demonstrate evidence of positively changing disease trajectory for Duchenne Pivotal dose participants exceeded external controls across functional ...
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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