COVID-19 pandemic has caused a major disruption in clinical trials worldwide. The disruption of clinical trials could be either due to delayed initiation of planned trials, temporary suspension of enrolment or slow recruitment of participants, and may potentially impact regulatory approval of innovative and lifesaving drugs for other diseases.
In the wake of these disruptions, the pharmaceutical industry is moving towards adapting new models to conduct clinical trials, including, but not limited to remote patient monitoring, adapting to virtual or decentralized clinical trials model and direct-to-patients drug delivery. The movement towards decentralized trials has been evident for several years, but COVID-19 has been a catalyst to enhance this movement. Decentralized clinical trials allow the collection of safety and efficacy data from study participants by using a range of digital technologies that require a minimum number of site visits. This can include telemedicine, wearable devices, eConsent, electronic clinical outcome assessments, and electronic health records. However, there are several challenges and changes that are required for successfully conducting decentralized clinical trials. This includes changing procedures, processes, and systems integration, as well as keeping up with the latest regulatory requirements. Moreover, decentralized trial models can be easily implemented only for certain diseases.
Based on B2B surveys and the clinical trials data, increased use of decentralized clinical trials is expected to be one of the emerging trends, not only to combat the disruptive impact of COVID-19 on clinical trials, but also to improve enrollment in clinical trials. However, this will require overcoming challenges and adapting to newer protocols to ensure that trial integrity and patient safety are maintained.
In this webinar Revati Tatake, Global Director at GlobalData, will present an analysis of clinical trial disruption due to COVID-19, how is pharma responding to the disruption of clinical trials and movement towards decentralized trials. Bonnie Bain, Global Head and EVP of Healthcare Operations and Strategy at GlobalData, will moderate a Q&A session following the presentation.
Key Learning Objectives
- Learn how COVID-19 has impacted clinical trials worldwide.
- Understand how the industry is finding ways to mitigate clinical trial disruption.
- Learn benefits and challenges for adapting to decentralized clinical trials model.
- Learn emerging trends and the outlook for clinical trials beyond the pandemic.