In the second edition of our blog series on decentralized clinical trials (DCTs), we address U.S. Food and Drug Administrations' (FDA) expectations of investigators articulated in the recently released draft guidance. Investigators continue to be responsible for overseeing the conduct of clinical trials, including DCTs, and the supervision of individuals delegated to perform trial-related activities. Such responsibilities include ensuring that delegated activities and/or tasks are conducted according to the investigational plan, and in compliance with applicable regulations, and relevant laws. Additionally, investigators continue to be responsible for obtaining informed consent from clinical trial participants, overseeing the administration of the investigational product (IP), and entering trial-related data for inclusion in trial records, when needed.
The key difference for investigators between DCTs and traditional site-based trials is the extent to which the investigator and/or sub-investigators use telehealth, trial personnel work remotely, local health care providers (HCPs) are leveraged, and/or digital health technologies (DHTs) are utilized in the conduct of the trial. Investigators may be required to perform additional training, coordination, and implement additional standard operating procedures (specific to telehealth, remote data capture and use of DHTs) to ensure consistent implementation of processes and procedures utilized in DCTs.
Specific Considerations
FDA notes that investigators may consider telehealth visits instead of in-person visits with trial participants if no in-person interaction is needed. Alternatively, investigators may use local HCPs to perform certain trial-related activities when permitted by the protocol. Such activities provided by HCPs should not differ from those that they are qualified to perform in their standard clinical practice, nor should the services require a detailed knowledge of the protocol or the IP.
Investigators must maintain a task log of local HCPs who perform trial-related activities as part of preparing and maintaining adequate case histories. The task log should include: (1) the names and affiliations of the local HCPs, (2) a description of their roles and assigned tasks, (3) the dates these local HCPs are added to the log, and (4) the locations where these activities are conducted. Trial personnel who contribute directly and significantly to the trial data should be included on the Form FDA 1572 as sub-investigators. Other HCPs not involved in the clinical trial who deliver care to trial participants but not as part of the trial should not be listed on Form FDA 1572, the task log, or a medical device sponsor's current list of investigators.
FDA specifies that investigators may use videoconferencing and other technologies to oversee/supervise trial personnel performing activities described in the protocol (e.g., photographing lesions, fitting wearable sensors) at trial participants' locations. Moreover, FDA encourages investigators to put in place quality control measures to help reduce variability, including a regular review of participant data entered by local HCPs, to assess consistency and completeness of required procedures.
Importantly, investigators should only enroll as many trial participants as they can appropriately manage to ensure adequate supervision of DCT-related activities, and investigators should take steps to help ensure that participants have access to an appropriate level of local care.
FDA further states that investigators must ensure that remote clinical trial visits conducted via telehealth comply with laws governing telehealth in the relevant U.S. States or territories and other countries, as applicable. FDA notes that investigators should confirm the trial participant's identity during each remote trial visit. We note that many states have specific identity verification requirements specific to use of telehealth. This is also true for informed consent. Investigators should be familiar such state-level requirements. Foley is an industry leader in the telehealth space and can assist research teams ensure compliance with these state laws and regulations.
DCT Series
For additional resources on how decentralized clinical trials will impact the world of health care and life sciences, click here to read the other articles in our series.
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