For the first time ever, the FDA has threatened enforcement and fines against a sponsor for failing to submit trial results to ClinicalTrials.gov by required deadlines. Read More
As clinical trial professionals prepare for postpandemic operations, they see technology adoptions and hybrid protocol designs as the innovations most likely to be continued after the crisis ends. Read More
After a two-year collaboration, two industry nonprofits have unveiled an approach for safety reporting that will help sites reduce the amount of duplicate adverse event (AE) data entry they currently do to meet sponsor and regulatory requirements. Read More
One research institution has hit on a formula to upgrade its business operations that has helped open it to more trial opportunities and made it more competitive, particularly in COVID-19-related trials. Read More
The FDA conducted about 34 percent fewer clinical investigator (CI) inspections in fiscal 2020 compared to the prior year, dropping from 516 to 338. Read More
More than 60 percent of current drug submissions to the FDA include real-world data (RWD) in some form, and agency officials are saying the FDA needs to expedite honing its skill set in regulating the use of it in trials. Read More
Sponsors are overwhelming sites with a growing volume of safety reports, and sites are fighting back. The magnitude of the problem of unnecessary and overly burdensome safety reporting is getting worse; in the past three years, some sponsors of oncology drugs have unleashed a five-fold increase in safety reports. Read More
Sites are facing a bottleneck in trial operations as they juggle restarting nonCOVID-19 trials, continuing ongoing COVID-19 trials and returning to their prepandemic plans for new trials. Read More
As clinical trials have increasingly become more global, researchers are realizing that underrepresentation of Blacks in U.S. trials is not addressed simply by adding more Blacks to trials from overseas, particularly in oncology trials. Read More
Creating a national community-based trial network would allow sponsors to tap into new investigators and reach a wider pool of participants, easing up on the industry’s reliance on larger research institutions. Read More