ClinicalTrials.gov users will have a chance to weigh in on strategies for improving the database at a public meeting scheduled for April 30, which is likely to be held virtually because of the COVID-19 outbreak. Read More
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their COVID-19 response that documents reasons for protocol deviations and other trial adjustments, according to a new draft guidance from the EMA.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