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
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
The FDA issued a 49-page draft guidance on how industry should go about asking patients what’s most important to them about how they are dealing with their disease and its treatment, to help companies better develop new drugs.
The second in a series of four planned guidances on facilitating a systematic approach towards collecting and using patient and caregiver input, the draft goes into detail on various research methods and notes how those methods can help in the development of clinical outcome assessments and the generation of patient preference information.
Using real-world data (RWD) and real-world evidence (RWE) in clinical trials is growing in popularity among both industry and the FDA, but both groups agree that all stakeholders need to be on the same page when it comes to definitions and ways to measure results.
“There is a tremendous interest in making use of the vast amount of data that’s already been collected in healthcare systems to more efficiently generate evidence,” the FDA’s Robert Temple told participants at a joint FDA and Duke University workshop last week.
Sponsors recognize the advantages of using a single system to handle all trial operations, but progress from theory to practice has been slow, a new survey shows.
Software company Veeva Systems’ recent survey of clinical trial professionals about the benefits of unified clinical operations — single centralized technology systems that handle all operations tasks — points out the major problems created by using disconnected systems for individual functions.