The FDA and EMA have both published initial guidance for drug-makers on conducting clinical trials during the COVID-19 pandemic, with patient safety at the forefront of all considerations. Specific measures include the conversion of physical patient visits into virtual visits and offering additional safety monitoring options for patients who can no longer access the investigational product or trial site. The FDA and EMA both acknowledge that clinical trial protocol modifications are likely to occur as trials continue to be adversely affected by COVID-19 in the coming weeks and months, though it is not clear how such considerations might affect future review in regulatory filings.
Apart from the general guidance offered by the FDA and the EMA, several medical professional associations such as the American Society of Clinical Oncology (ASCO), the European Society for Medical Oncology (ESMO), and the National Comprehensive Cancer Network (NCCN) have all provided resources informing members as to the appropriate conduct of clinical study during the pandemic. These recommendations largely echo those set forth by regulatory agencies but also provide important context relevant to specific disease areas and include recommendations on restricting non-urgent diagnostic and screening tests, conducting patient safety follow-up visits by phone, and coordinating with study sponsors to arrange for research medications to be sent directly to subjects if feasible.
In addition to the recommendations of medical societies, individual hospitals, academic centres, and community practices have also implemented their own individual clinical care guidelines, each offering distinct patient screening and testing protocols, policies and procedures, and administrative and clinician tools. The common refrain across institutions is restriction of enrollment in clinical studies to those that are most likely to benefit patients. The extent to which clinical studies will ultimately be prioritized as the burden of the pandemic on the healthcare system increases is still to be seen, however we expect potential sites to become much more selective over trial participation in the short to medium term.