Clinical research during coronavirus disease pandemic: Challenges and way forward

Abstract

With the novel coronavirus disease (COVID-19) being declared a global pandemic by the World Health Organization, the Indian health-care sector is at the forefront to deliver optimal care but with constrained resources and several challenges. The pandemic has also brought about a state of urgency to develop suitable management principles for COVID-19 with the help of suitably designed clinical trials. However, the pandemic along with the lockdown and other restrictions has affected the conduct of clinical trials in terms of restrictions on travelling, trial site staff availability, investigational product availability, and medical oversight among others. This article provides structured recommendations for sponsors, investigators, clinical trial personnel to adapt to the situation by identifying potential risks and challenges and mitigating them to conduct clinical trials well within the ambit of local regulatory guidelines and requirements during the COVID-19 pandemic.