To get through the COVID-19 crisis with their trials intact, sponsors and sites should take a new look at their data and data collection methods, including evaluating whether a trial will have enough reliable data to support a positive decision, finding ways to collect more data or using data monitoring committees (DMCs) to help assess and modify studies. Read More
The FDA has updated its guidance on conducting clinical trials during the COVID-19 pandemic with an extensive Q&A section, including a long list of factors to consider when deciding the status of ongoing trials and ones soon to be initiated, as well as how to obtain informed consent remotely. Read More
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their COVID-19 response that documents reasons for protocol deviations and other trial adjustments, according to a new draft guidance from the EMA.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