A wide cross-section of industry players have praised the FDA’s recent draft guidance on using electronic health records (EHRs) and medical claims data in clinical trials, but they hope the agency will acknowledge issues inherent to real-world data (RWD), offer clarity in certain areas and be flexible as sponsors adjust to the new guidance. Read More
As the digital therapeutics/software as a medical device sector continues its significant growth, clinical trials for the products are projected to expand logarithmically. Read More
Protocol complexity is continuing to climb, adding unplanned time and cost to clinical trials, according to a new report that found the number of deviations and substantial amendments has increased almost four percentage points in the past decade. Read More
Decentralized trials (DCT) are becoming more dominant in clinical research, but it’s critical for sites to realize the key differences between DCTs and traditional trials and have the right metrics in place. Industry isn’t quite there yet, experts say. Read More
In response to criticism over its user privacy practices, Facebook will soon tighten up its options for reaching people through ad campaigns, a move that may dampen recruitment efforts for some trials. Read More
For the first time in 30 years, the number of novice investigators — those who conduct only one trial — is declining and the pool of experienced investigators is growing, leading to a drop in investigator burnout and turnover rates, particularly in the U.S. and Canada. Read More
Oncology trials are bogged down by a number of serious challenges that significantly impact sites and research timelines. Decentralized trial (DCT) approaches could simplify many of these complexities, but hesitancy about adoption still remains. Read More
Efforts to improve diversity in research appear to be paying off for Black Americans, but other minorities still aren’t being adequately represented in trials, a new FDA analysis shows. Read More