US FDA Outlines Wishlist For Decentralized Clinical Trials
Companies Need Not Have An ‘All Or Nothing’ Approach
As interest in conducting remote decentralized clinical trials grows, a senior US regulator explains what companies should consider when planning such trials.
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A new multi-stakeholder alliance wants to improve the adoption of decentralized clinical trials that have already drawn much attention during the COVID-19 pandemic. There are plans to aggregate best practices, share evidence and information, and identify and address key barriers.
Work on guidance that was originally expected in 2020 continues as the agency and industry learn more about the utility and spectrum of decentralized trials as a result of the novel coronavirus pandemic.
Robert Califf, a former FDA commissioner turned Verily Life Sciences exec, is just one of the voice predicting a long-term impact on clinical trial processes from the COVID-19 outbreak.