The issues posed by the COVID-19 pandemic have led to a roughly 30 percent increase in site costs, with much of the increase stemming from sites being forced to quickly adopt remote monitoring and other measures in response to the crisis, experts say. Read More

The outbreak of COVID-19 had an immediate negative impact on cancer research, causing confusion, trial closings and a need for hasty adaptation to protect its vulnerable patient population, but it’s also ushered in important changes in oncology trials that could have long-term positive effects. Read More

The severity of the COVID-19 pandemic could justify the use of human challenge studies in vaccine development, and their careful use may be worth considering if they’re conducted the right way, a medical ethics expert argued. Read More

The worldwide rush demanded by the pandemic to develop and/or identify a potential treatment or vaccine has culminated in remarkable success in expediting COVID-19 trials, and the lessons learned are likely to be applied even after the pandemic is over. Read More

Although FDA regulations require sponsors to disclose significant trial changes to participants and obtain their permission to continue in the trial, “reconsent” is not an official regulatory term and there are no specific rules on how to convey those changes. Read More

As the COVID-19 pandemic pushes sponsors toward conducting remote outcome measures, it’s important for them to ensure that data they gather and the conclusions drawn from them are still valid and reliable. 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

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

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

Former FDA Commissioner Scott Gottlieb said he expects the U.S. to become capable of conducting broad screenings this week due to the FDA’s emergency approval of Roche’s coronavirus test. When those capabilities are realized — enabling tens of thousands of patients to be tested daily — “we’re going to turn up a lot of new cases,” he said. Read More