Protocol changes and deviations may be unavoidable to ensure the safety of trial participants during the COVID-19 crisis, the FDA says in a rare direct-to-final guidance released this week, and sponsors and investigators should examine alternatives to face-to-face trial procedures.
A survey conducted by Clinical Research IO has found that 24 percent of investigators across 73 different research sites have stopped new patient enrollment due to concerns about COVID-19. Another 37 percent of investigators who responded to the survey say they are considering ceasing new patient enrollment due to COVID-19 safety concerns. Read More
Regulators in the UK will only conduct essential on-site inspections of clinical trials, distribution, laboratories, manufacturing and pharmacovigilance during the COVID-19 outbreak, according to new guidances issued last week. Read More
Sponsors of clinical trials in the EU should create a systematic plan for their COVID-19 response that documents reasons for protocol deviations and other trial adjustments, according to a new draft guidance from the EMA. Read More
A meeting report from a regulatory workshop held virtually under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA) provides an overview of new regulatory considerations for the development of COVID-19 vaccines and data requirements for phase 1 COVID-19 vaccine trials. Read More
Patient centricity is truly coming to the forefront as sponsors and investigators search for ways to battle the effects of COVID-19 and keep their trials afloat while protecting their participants’ health and safety. Read More
Sponsors and sites must reassess the risks of all their ongoing trials in the face of the COVID-19 pandemic, looking for factors that may increase the severity of already-identified risks and new, unanticipated risks presented by the virus. Read More