By Rajneesh Patil, BDS, MBA, FPH, Head – Digital Strategy & Innovation, Clinical Operations and Christopher Varner, Project Manager, IQVIA Virtual Trial Solutions
We have entered a new era of clinical development. In response to COVID-19, the industry took a great leap forward to bring clinical trials closer to patients – most of whom had to stay at home – and at a scale never achieved before. Site access constraints and elevated concerns about patient safety in the pandemic environment sparked regulatory agencies to expand their guidance to include the use of virtual clinical trial tools – from remote monitoring to telemedicine, direct-to-patient shipment of investigational medicines to the use of home health nurses in clinical research. Many sponsors and clinical research organizations embraced this opportunity to innovate and use this newfound urgency to utilize innovative, flexible clinical trials models and approaches to ensure critical drug development continued through the pandemic.
Through this experience, as drug developers more readily adopted remote, patient-centric tools to keep patients safe and studies progressing, technology-enabled clinical trials solutions, including virtual trial models and remote clinical monitoring, are providing a much-needed lifeline to trial continuity and priming the drug development ecosystem for greater adoption of patient-centric clinical trials in the future.
This paper will discuss how clinical trial models are evolving as sponsors rethink the traditional research paradigm and adopt patient-centric clinical technologies and approaches, including telemedicine and remote clinical monitoring. With COVID-19 giving urgency to this transformation, the scope of this discussion will focus on two priority areas for sponsors and researchers alike: better understanding the need for potential shifts to decentralized trial models and what sponsors need to consider as well as a deeper look into key components of virtual trials.