VIRTUAL TRIALS: HOW COVID-19 HAS TRANSFORMED CLINICAL RESEARCH

*Shaik Sana Shinine, Noorush Shifa Nizami, Priyanka Deepak Shinde, Mohammad Zehera Sulthana, Shriniwas Ramkrishna Kairamkonda

ABSTRACT

Clinical trials play a crucial role in assessing the safety and effectiveness of new medical treatments, devices, and healthcare interventions. Traditionally, these trials involve a series of in-person visits for eligibility checks, participant enrollment, administering interventions, collecting data, and conducting follow-ups—steps often requiring direct interaction between participants and researchers. However, the COVID-19 pandemic, and the resulting need for social distancing to limit virus spread, disrupted this model, causing many trials to suspend in-person activities except when essential for life-saving research. Despite these obstacles, clinical research continued as study teams swiftly adapted to virtual methods, allowing key trial activities to proceed remotely. This report focuses on the rapid shift to virtual practices within Clinical and Translational Science Awards (CTSA) centers and outlines key factors for further development. Looking to the future, a blended approach that combines virtual activities with necessary in-person visits is likely to become more common in clinical trials. While certain aspects of research will still require face-to-face interaction, future trial designs will need to incorporate remote options wherever possible.

Keywords: Clinical trials, virtual visits, remote methodologies, COVID-19, social distancing, hybrid approach, in-person visits.