Posted by Michael Wonder on 05 Jun 2024
Why should the FDA focus on pragmatic clinical research?
3 June 2024 - Traditional randomised clinical trials have long been a key tool underpinning drug and device development.
The use of individual participant randomisation and active or placebo controls in randomised clinical trials, combined with comprehensive collection of highly structured data, supports assay sensitivity.
At the same time, focused enrolment criteria and careful attention to the collection of adverse events for specified follow-up periods promote detection of toxicities and risks.
