International – How regulators have adapted globally to clinical trials for drugs and biologics during the COVID-19 crisis

The COVID-19 pandemic has disrupted clinical trials globally and has resulted in a 65% worldwide decrease in new patient enrollment year-over-year during March 2020. As a result, regulators across the globe have issued new guidances to support the industry in their hour of need.

The US Food and Drug Administration (FDA) has launched a special emergency program for possible therapies for COVID-19 – the Coronavirus Treatment Acceleration Program (CTAP), which combines elements of multiple existing review pathways. It was under CTAP, for example, that the FDA issued the emergency use authorization (EUA) for remdesivir. While there are over 50 regulatory pathways available for sponsors to get their drugs or biologics approved, there are 22 pathways that the FDA would be most likely to leverage under CTAP. Under CTAP, FDA will be providing “ultra-rapid, interactive input”, completing protocol reviews within one day, and “round-the-clock” single patient expanded access request review within three hours. This is a striking reduction in the standard protocol review timelines of 30 days for a Phase 1 protocol, to up to 90 days for a Phase 3 protocol, the four days response time for non-emergency requests and less than one day for emergency requests for expanded access.

The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) consortium launched by the National Institutes of Health (NIH), in collaboration with 16 biopharma companies, FDA, Centers for Disease Control and Prevention (CDC), Health and Human Services (HHS) and European Medicines Agency (EMA) represents an unprecedented collaborative framework between industry and regulators to support and  prioritize the global development of therapeutics and vaccine for COVID-19. Of 39 prioritized agents, ACTIV has chosen six agents to be moved ahead into the master protocol clinical trial(s) and has supported the use of platform trials and master protocols to enable the simultaneous testing of multiple therapies. Sponsors planning on implementing platform and adaptive designs should discuss their trial’s plans in advance with the agency…