Remote and flexible trial approaches have been a hallmark of clinical trials during the pandemic and are widely believed to have been the primary factor in keeping trials open and operating. Now, there is evidence showing that such measures as telehealth visits, off-site diagnostic/monitoring procedures and remote consenting were at least partially responsible for the ability of lung cancer trials to weather the storm. Read More

Sites conducting pediatric research continue to hit two barriers, according to a new analysis of pediatric trials. Trials are too often abandoned by sponsors focused on commercial, rather than scientific, success. And a lack of data-sharing and reporting of results limits what sites can learn from each other. Read More

A record high number of U.S. trial starts combined with persistent site staffing shortages is creating a pileup of trials that sites are finding very difficult to wade through. The solution is a more selective approach to accepting trials that focuses limited resources on high-value targets to keep research moving forward in the most important areas. Read More

Faced with an injury in a trial, sites must walk a fine line to make sure the injured participant is reimbursed properly without billing the wrong responsible party for unexpected medical care or failing to bill at all. Read More

FDA inspectors are taking a closer look to confirm that quality management systems are being used in trials, experts say, citing the updated Bioresearch Monitoring Program (BIMO) inspection guide. Read More

The FDA is making moves to advance cancer research by finalizing three guidances aimed at encouraging trial designs that can deliver faster and better-quality results. Read More

Patient recruitment, not study startup, is the biggest obstacle in conducting central nervous system (CNS) trials, which increasingly use decentralized trial (DCT) methods to ease the way, a new survey shows. Read More