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
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
WCG Clinical hosted a widely listened-to webinar last week to discuss the impact of COVID-19 on trials. The questions and answers are edited excerpts… 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. 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
Sponsors are reacting rapidly to the coronavirus outbreak and trials are being delayed, especially those that take place in hospital or emergency care settings, while a significant number are shifting toward the use of remote patient interactions over traditional visits. Read More
Designers of precision medicine trials need access to more data sources than traditional trials to refine the parameters of their studies and boost enrollment. Read More
The number of women who participated in clinical trials that led to FDA drug approvals increased dramatically in the past year, rising from 56 percent of trial participants in 2018 to 72 percent in 2019, driven more by an increase in testing drugs specifically aimed at women than gender diversity. Read More
Calling an HHS interpretation of a final rule on a 2007 law “unlawful,” a federal judge ruled last week that the results from up to 12,000 trials not reported to ClinicalTrials.gov will have to be added to the trial database. Read More