FDA Releases Guidance for Wearables and Apps in Clinical Trials
(Thursday, January 6, 2022)
FDA would like clinical trials using remote data collection devices such as wearable gadgets and phone apps to consider five factors that may influence the reliability and acceptability of the data generated. The devices or apps (software) must be diligently selected to assure it is suitable for the expected data, it should be verified and validated for the trial before implementation, the data collected must be linked to specific study endpoints, written risk management plans should be created to preempt any risk, and any risk events related to the use of smart technology must be appropriately managed and documented. As always FDA wants the sponsor to discuss the appropriateness of the devices and technologies with the regulators prior to use but allows common sense measures irrespective. The guidance discusses these five criteria with examples and suggestions to address potential issues. The most important aspect of device selection that might often get overlooked is the Usability studies that are needed to validate a given technological platform in clinical trials. Once implemented in a clinical trial privacy protection and appropriate informed consent process dominates the risk of a data collection device in clinical trials. The guidance also provides a checklist of sorts in the end to assist sponsors considering digital health technologies in their trial. Overall the guidance provides an elaborate discussion on topics relevant to clinical trial sponsors, investigators and patients alike and should be one of the first must read documents for clinical trial professionals.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC