COVID-19 Clinical Trial Disruptions: A Real-World Test Of De-Centralized Techniques
US FDA asks oncology drug sponsors for information on the impact of modifications to clinical trials during the pandemic – with close attention to remote monitoring and data collection.
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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.
Under certain circumstances, potential clinical trial participants may be able to provide informed consent by writing on a blank piece of paper that they voluntarily agree to participate in a given protocol and texting or emailing a photo of the signed document to the investigator, US FDA says in latest guidance update.
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.