Clinical trials will enter the digital age according to Indian researchers who say the COVID-19 pandemic has finally convinced CROs to swap pen and paper for data.
The study published in Perspectives in Clinical Research looked at use of digital technologies in clinical trials which, the authors predicted, is likely to increase markedly over the next few years partly as a result of the pandemic.
“The site-based model of a clinical trial includes steps such as on-site patient visit, recruitment, interventions, or any diagnostic workups by investigators team at a specified time interval.
“Given the current COVID 19 pandemic crisis, such a conventional approach can be jeopardized due to restriction in travel, social distancing, and less physical contact.”
Many aspects of a clinical trial would benefit from a digital approach according to the authors, who also point out that the technologies needed to digitize a trial are already available.
“In any virtual clinical trial, such steps can be executed through novel technologies involving telemedicine, e consenting, or remote site monitoring methods such as apps or electronic devices. Therefore, the adoption of such digital health technologies would foster the transformation of a conventional design aided by necessary investment along with regulatory support.”
The researchers said while the digital concept is not new – citing Eli Lilly’s use of digital consent in a 2001 tadalafil study, Pfizer’s REMOTE and Sanofi’s VERKKO programs – COVID-19 has helped industry recognize its benefits.
“Due to the ongoing COVID-19 pandemics, there have been extensive reports of termination as well as delays in ongoing trials globally. Most of the impedance was attributed to postponement of enrolment followed by slow enrolment and delay in initiation.
“Paucity in the availability of research sites paved the way for slow enrolment due to the overwhelming presence of COVID-19 patients in many of the health-care facilities… Digitization of trial could well be utilized to counteract the aforementioned situation.”