25/26 October 2022
The FDA provides recommendations for sponsors, investigators, and other interested parties on the use of digital health technology (DHT) for remote data acquisition in clinical trials. According to the agency, a DHT is a system that uses computing platforms, connectivity, software, and / or sensors, for healthcare and related uses. In addition, the draft guidance addresses some of the information that should be contained in an investigational new drug application (IND) or an investigational device exemption (IDE) application for a clinical trial (CT) in which the sponsor plans to use one or more DHTs or in a marketing application that includes such a CT.
Sponsors should ensure that a DHT used for remote data collection in a CT is fit-for-purpose. Sponsors can use verification (i.e., confirmation that the DHT measures accurately and precisely over time) and validation data (i.e., confirmation that the DHT appropriately assesses the clinical event or characteristic in the proposed participant population) made available by DHT manufacturers or other third parties, when appropriate. Verification is often viewed as part of the validation process. In addition, usability studies should demonstrate that the DHT can be used as intended by the trial population, without serious errors or problems.
The FDA draft guidance Use of Electronic Records and Electronic Signatures in Clinical Investigations provides recommendations on the use of electronic records in CTs. The document addresses mobile technologies that allow for remote data capture directly from participants, as well as related issues pertaining to access controls, data sources, inspections, and audit trails. Sponsors should discuss with FDA the type of DHT data recorded from each participant to be submitted for FDA review. For data collected directly from study participants through DHTs, the agency would generally consider the data in the durable electronic data repository to constitute the source data.
Review of these data may be necessary to reconstruct and evaluate the CT, and the data should be available for inspection. When the protocol specifies review of the source data by the clinical investigator, the investigator must retain these source data as part of the adequate and accurate case histories required. The investigator must also permit FDA to access and copy these case history records.
Contingency plans should be made for changes to the DHT. Moreover, sponsors should:
More detailed information is provided in FDA´s draft Guidance Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.