Oversight of data monitoring committees (DMC) and endpoint adjudication committees (EAC) can be handled most effectively by specialty third-party providers that can help bolster trial credibility and productivity while cutting down on risk, bias and perceptions of bias, says one expert. Read More
With the help of a multistakeholder task force that included the FDA, sponsors, sites, ethics committees and patient advocates, the Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women’s Hospital and Harvard has published a toolkit that lays out critical ethical considerations for decentralized trials (DCT). Read More
Application of risk-based quality management (RBQM) is still limited in trials, according to new data that show sponsors and CROs use RBQM elements in about half of trials overall and hold varying perceptions of their benefits. Read More
CROs’ performances in areas pivotal to sites have been on a notable decline since at least 2019, sites reported in WCG’s 2023 Global Site Relationship Benchmark Survey, echoing a similar downward trend for sponsors. Read More
Sponsor performance on attributes critical to sites continues a downward slope across the board, according to findings from WCG’s latest Global Site Relationship Benchmark Survey that spotlight key improvements sites feel sponsors still need to make. Read More
Fewer than one-in-five sites strongly feel trials are being crafted with them in mind, highlighting an unmet need for greater engagement by sponsors, a new survey finds. Read More
A clear-cut tech strategy is critical for sites in this technology-heavy climate, yet many function without one, opening them up for inefficiencies, extra burden, disconnects and overall fatigue, warns one site network expert whose organization developed an approach that systematically evaluates, implements and cyclically reassesses its tech solutions. Read More
In this time of growing trial complexity, the use of patient advisory boards is critical to improving the patient and site trial experience — but just a small fraction of protocols currently use them, according to two WCG experts. Read More
The top challenges named by sites in a recent WCG Clinical survey — staffing, recruitment, trial complexity and others — are not new but are increasingly impacting sites’ ability to take on new trials, the survey says. Read More
The FDA’s long-awaited draft guidance on decentralized trials (DCT) is finally out and industry has been abuzz with discussion. Experts feel it has arrived at a pivotal moment for clinical research and does many things right, but some recommendations may draw industry pushback. Read More