Clinical trial activity picking back up will likely be dependent on regional factors and sponsors should not expect to see a “day one” for recovery — but they should keep an eye out for certain recovery indicators. Read More
While some sponsors are pulling back on enrollment and site activation, others are expressing confidence that they can continue their trial activities with adjustments to avoid the risk of COVID-19 exposure. Read More
WCG Clinical has launched a new COVID-19 online patient resource center to help trial participants understand how the pandemic may affect their trials and to help prospective participants match to clinical trials via CenterWatch iConnect. Read More
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