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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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.
A US National Academies meeting on digital health technology showcased the communication gap between regulators and tech developers when it comes to important concepts like “digital biomarkers.”