Virtual Patient-Doctor Interactions for Care and Clinical Trials Should Stay
(Thursday, February 3, 2022)
Remote care has arrived, thanks to the pandemic. For clinical trials also virtual or remote trials have become a necessity with all trials switching to remote trial management and operations to an extent unfathomable just two years ago. So, why do we even need to go back to the old 2019 methods? Perhaps this is how care and clinical trials should be always run. Patients are far more comfortable interacting with their doctors via emails and video meetings that going to a clinic to meet the doctor. Not just because of the ease of communicating but also savings on the cost and time fronts. Most of the medical care can be provided remotely such as diagnosis, prescription, and follow-up. Similarly, in clinical trials, all study operations starting from recruitment to study specific visits, follow-up, data collection and quality checks, most adverse event management, and project management can be and is being done remotely. For clinical trials, the biggest hurdle to moving virtual has been documentation processes. Sites that were used to collection huge troves of printed binders found it harder to move to electronic documents. Many of the electronic medical record systems are not designed for clinical trial operations, rather only for medical records and payor management. With regards to source documents and trial master file management, more than 60-80% of the clinical trials still use paper documents at least for critical documents. More importantly FDA auditors and monitors still expect to see physical binders at the site audits, which leads to unnecessary hard copies that need to be reconciled with the electronic documents. There are no formal studies and data to describe how widespread the issues with switching from conventional to electronic are, but conventional wisdom dictates that unlike clinical care, where the switch to remote was very rapid and effective, the same is not true for clinical trials. The main factor could be that while clinical care continued during the pandemic for obvious reasons, clinical trials were paused and then slowly restarted, which lead to delays in implementing, validating, and troubleshooting issues. But we have come a long way in this direction and there is no going back. There should not be.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC