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Researchers planning trials on the use of convalescent blood plasma to treat COVID-19 must submit an investigational new drug (IND) application, according to a new FDA final guidance that will remain in effect only for the duration of the public health emergency. Read More
Year-over-year global clinical trial enrollment dropped nearly 65 percent per study site in March because of COVID-19, especially in trials focused on endocrine disorders and trials conducted in India. Read More
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
Applications for clinical trials in Belgium can now receive the go-ahead from the government within four days rather than the two to four weeks sponsors previously had to wait. 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
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