My first exposure to telemedicine was in 2012 when a close family friend, a 27-year old male with severe, chronic health conditions, was taken by ambulance to the hospital, where he was immediately admitted to the ICU. Via a telemedicine visit, the physician told us that my friend was going to die. I remember being appalled. How dare this doctor have the audacity to tell us something so earth-shattering over a video chat session? I stood fast against all telemedicine for several years until my thinking eventually took a complete 180 degree turn. Fast forward to March 2020 when I encountered my second telemedicine visit, this time with my PCP to discuss some abdominal pain I’d been having. The visit could not have gone better. I didn’t have to drive to and from the doctor’s office. I didn’t have to wait in the uncomfortable waiting room chairs. I didn’t then have to wait even longer in the exam room. The video visit with my PCP went smoothly, and a few days later, I was in another virtual visit with a GI specialist—again, receiving the care I needed without any of the inconveniences. (Readers, don’t worry, I did go into the clinic for lab tests.) Today, I think telemedicine is a hugely valuable service that provides myriad benefits to patients, clinicians, and the healthcare system at large.
As we all know, these types of remote interactions—often termed eClinical Technology—are making their way into clinical trials, too. Precipitated by the COVID-19 pandemic, we have seen an uptick in the adoption of televisits, remote monitoring, and eConsent in clinical trials. With the advantage of hindsight, it is fascinating to do an internet search on the “demand for eConsent in clinical trials over time.” You’ll find articles: “What Is Holding Back the Adoption Of eConsent?” (January 2019), “Is eConsent Adoption Poised to Grow?” (September 2017), and “The Journey To Global eConsent Adoption: Where Do We Currently Stand?” (September 2019).
Spurred by COVID-19, sponsors, IRBs, and other governing bodies are now allowing adoption of eClinical Technology in clinical trials more broadly than they otherwise would have. In the near future, all stakeholders are going to be able to look back at this “natural experiment” and analyze actual data on the benefits and detriments of eClinical Technology in clinical trials. Advocates of eClinical Technology in clinical trials purport that it improves efficiency, lowers costs,1 enhances patient participation, accelerates recruitment, and improves data quality and early signal detection.2 Skeptics reason that it introduces privacy concerns, presents the challenge of keeping up with technological advancements, introduces biases based on factors such as demographic or socioeconomic status,1 leads to data interpretation issues, and is burdensome for patients and providers.2 I, personally, suspect that the benefits of eClinical Technology in clinical trials will far outweigh the disadvantages, but now that data is being collected on an unprecedented scale, I can’t wait to find out what the evidence says!
- 1Carmen Rosa, Aimee N. C. Campbell, Gloria M. Miele, Meg Brunner, and Erin L. Winstanley. Using e-technologies in clinical trials. Contemp Clin Trials. 2015 Nov; 45(0 0): 41–54.
- 2Ashish Kumar Kakkar, Phulen Sarma, and Bikash Medhi. mHealth technologies in clinical trials: Opportunities and challenges. Indian J Pharmacol. 2018 May-Jun; 50(3): 105–107.