Compliance and Data Integrity Issues with Remote Clinical Trials
(Thursday, May 27, 2021)
The pandemic necessitated remote clinical trials where almost all the trial activities were done at the home of participants rather than in clinics. Remote clinical trials while being quite efficient and productive raise new questions about data integrity and reliability. How does one monitor data collected and submitted by the patient remotely? Several trial specific activities are easy to transition to remote interactions. Informed consent, physical health data, patient reported outcomes, study drug dispensing and accountability, and follow-ups can be easily done remotely. Some outcomes can be collected at participants’ homes by study staff, and the blood or biospecimen testing samples can be collected at home and send to central labs or the patients can be sent to the labs for tests. Trials can also use smart- and wearable device to capture several data elements from study participants. However, with wearable devices, the issues to accurate attribution of the data becomes an issue. Study staff need to find ways to verify that the data is coming from the study participants. For example, unless the device carries biometric identity information, it is hard to verify that the participants did not cheat such as having someone else wearing the device. Behavioral data are less reliable when collected remotely. Study operations that involve special skills or equipment such as sterile technique for sample collection, biopsies cannot be collected remotely. The pandemic offered an unparalleled opportunity to work out the kinks in remote clinical trial operations. Most of these practices are here to stay after the pandemic. Measures for the reliability, accuracy and integrity of remotely collected data have also been developed and will likely need greater consideration.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC