The FDA has issued a final guidance that describes the use of digital health technologies (DHT) for remote patient data collection from participants in clinical trials. The guidance uses the term 'fit-for-purpose' for ensuring the device will be appropriate for the study and notes in the guidance that this means "that the level of validation associated with the DHT is sufficient to support the use, including the interpretability of its data in the clinical investigation), which involves considerations of both the DHT's form (i.e., design) and function(s) (i.e., distinct purpose(s) within an investigation". With the recent expansive use of decentralized clinical trials and their expected increase, this guidance will need to be read and complied with by anyone running or supporting a clinical trial using a DHT to ensure that the data collected and used within the trial meets these new standards.
Link to final guidance.
#FDA #DigitalTechnologies #clinicaltrials #RemoteDataAquisition
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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