NASH Clinical Development During the COVID-19 (Coronavirus) Pandemic

The COVID-19 pandemic has brought unprecedented challenges in clinical development. Travel restrictions, social distancing and the fear of contracting the disease are impeding conventional trial conduct. Typically, routine patient and monitoring visits to healthcare facilities are now the exception, study coordinators and site staff have increased demands on their time and, in some cases, layoffs have rendered some sites incapable of continuing as usual. To help keep patients safe and allow trials to progress, regulatory authorities worldwide have issued guidance for industry, investigators and institutional review boards. Exceptional measures are rapidly being put in place in different countries. As a consequence, we have witnessed a range of responses from sponsors on clinical trial activity, such as delaying trial starts, halting screening/enrollment in most ongoing studies and changing Investigational Medicinal Product (IMP) distribution and site visits. Our ability to adapt our approach in this ever-changing environment is critical and as a company Covance is at the forefront of partnering with specific vendors who are able to assist us in virtual technologies. These technologies enable virtual patient visits through telemedicine and phone interviews, shipping, storage and self-administration of IMP at patients' homes and remote CRA monitoring visits. Trials that are targeting a Q3 or Q4 2020 start could accelerate the start-up period by activating all sites prior to First Person In (FPI), enabling a large proportion to start screening and enrolling simultaneously once the hold is lifted. These suggestions could help trials move forward in the face of quarantine and travel limitations, clinical site closures and altered supply chains. The objective of this webinar is to present a current perspective on how COVID-19 is creating challenges specifically for NASH clinical trials, and discuss advantages and limitations of the proposed methodologies to overcome these challenges.