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.
Establishing a fair market value for a clinical trial that both sponsors and sites can agree on often is easier said than done. There is little or no consensus on the “fair” price to be paid for clinical trial services. Instead, sites should focus on providing a solid defense for each expense they expect a sponsor to foot. Read More
A sponsor chooses a site based on its ability to conduct the research, not on its financial management skills. But poor money management can sink a trial regardless of how well the site conducts the research. Read More
Collaboration, integration and data-sharing are popular concepts in a life sciences industry focused on finding novel treatments to meet critical healthcare needs. But are clinical trials really ready to “walk the walk” when it comes to making their data accessible to other sponsors and researchers? Not just yet, say industry experts. Read More