What the Pandemic Taught Us About Decentralizing Clinical Trials
In Regulatory Rapporteur, PPD’s Ilse-Maria Nolan, senior director of regulatory affairs, and Aneta Tsolovska, principal regulatory affairs specialist, reflect on lessons learned from the pandemic and explore future possibilities of flexible decentralized clinical trial models.
COVID-19 proved disruptive to the traditional clinical trial model of in-person and on-site visits. With the pressure of the pandemic looming, sites began to suspend or significantly decrease research activities at the agreement of regulatory authorities (RAs) and ethics committees.
Adaptation to this new normal required a shift to decentralized clinical trial (DCT) models and digital solutions that brought the study to the patient. DCTs offer benefits such as greater patient access and patient diversity and could also lead to permanent changes in the future.
In 2020, RAs provided initial support by approving digitally enabled activities to ensure that important clinical trials were able to safely move forward despite COVID-19. Pharmaceutical and biotechnology companies are increasingly shifting to flexible, digital trial solutions, and now, there are indications that RAs are willing to further adopt DCT strategies following the pandemic.
In this article from Regulatory Rapporteur, PPD experts look back at some of the lessons learned from the pandemic and explore future possibilities of flexible DCT models.