Virtual Clinical Trails and Reshaping Research Delivery

Abstract

The global clinical research is transforming with the integration of digital technologies and giving rise to Virtual Clinical Trials (VCT). This system allows participants to engage remotely through technology rather than traditional site based trails. By giving them flexible, patient centric approach to drug development and collection of data. In covid-19 pandemic time, this way of conducting the trails has gained significant attention, where physical interaction between the patient and clinical trial co-ordinator is neglected. And also during the pandemic time different terms are used in different jurisdictions including teletrials, networked trails, digital trails and decentralized clinical trials (DCT). Virtual clinical trials also use variety of tools that include Electronic informed consent(eConsent), Remote monitoring devices, mobile health applications, telemedicine etc. These technologies are mainly used for transmission of real-time data, reducing the need for in-person visits while involving in data collection, patient adherence, and overall trail efficiency. Virtual clinical trials are mainly involving in following the guidelines that are issued by authorities like the Food and drug administration (FDA), European medicine agency (EMA), International council for harmonization of technical requirements for pharmaceuticals for human use(ICH). However, to ensure trail integrity and participant safety the challenges such as data privacy, platform interoperability, cyber security, validation of digital endpoints must be carefully addressed. To ensure equitable access to virtual research platforms, especially in developing countries, there is a need for robust digital infrastructure. For combining both the virtual and in-person components, the pharmaceutical companies and contract research organizations are increasingly investing in hybrid models.