keyword fda-approvals 
Rethinking Clinical Trials
JUNE 29, 2022
Food and Drug Administration (FDA). Big data; Real-word evidence; Real-world data; 21st Century Cures Act; FDA Draft Guidance. With the 21st Century Cures Act of 2016, the FDA established a program to evaluate the potential use of real-world evidence to support new indications for drugs and satisfy post-approval study requirements.
Rethinking Clinical Trials
JULY 27, 2022
ACTIV-6 is testing medication doses approved by the FDA for other purposes, i.e., repurposed drugs. Participants test positive for COVID-19 with a FDA-authorized test, register from home, are randomized remotely, receive study medication through the central pharmacy, and follow instruction until their clinical symptoms improve.
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Rethinking Clinical Trials
MAY 25, 2023
The study required an FDA exemption because Aspirin is not approved for this indication. The primary hypothesis was that all-cause mortality is non-inferior with Aspirin compared to LMWH among orthopedic trauma patients. The pragmatic randomized control trial was designed from a hospital policy perspective.
Rethinking Clinical Trials
MARCH 1, 2023
For the investigational ramucirumab plus pembrolizumab arm, the drugs are administered per FDA package insert and institutional standard in a 21-day cycle under one of the criteria for removal is met. They are both approved and used widely in lung cancer, and combining two existing agents is logistically and clinically simpler.
Roots Analysis
NOVEMBER 3, 2023
As a starting point, the information on terminated, suspended and withdrawn trials was collated from clinicaltrials.gov and PubMed using relevant search keywords. This lack of drug efficacy has been a significant factor in drug failure, as it has prevented NAMPT inhibitors from receiving regulatory approval.
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