We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Health care advocates and drugmakers are hoping to build patient engagement into an earlier, more integrated and standardized part of clinical trials, amid a torrent of patient-centric efforts taking over the industry. Read More
The European Medicines Agency has released draft guidance explaining how drugmakers can use pharmacodynamic and pharmacokinetic analyses to hasten the development and review of new antibiotics. Read More
A large-scale shift toward using electronic consent in clinical trials — rather than older, clunkier paper versions — could improve understanding of the process, speed up enrollment and enhance trial monitoring, but sponsors and sites must be willing to adapt to the changes, an expert says. Read More
As centralized risk-based clinical trial monitoring becomes the norm, sponsors are gaining access to broad overview data on research and compliance trends that can help them identify both real and potential problems across their trial locations. Read More
The European Medicines Agency is seeking feedback on the International Conference on Harmonization’s revised E6 guideline, which adds new recommendations for sponsors on developing risk-based quality management systems for clinical trials. Read More
Clinical trial patients are beginning to review their study sites on social media forums like Yelp, and one expert says sites should start thinking about how to manage their online reputations. Read More
The primary efficacy endpoint in clinical trials for uncomplicated gonorrhea should be a negative culture at the infection site three to seven days after receiving antibacterial drug therapy, the FDA says. Read More
A San Diego, Calif.-based clinical researcher received an FDA warning letter over its lack of documentation of standard operating procedures for overseeing studies and details of in-service protocol and specimen handling training in a Form 483 response. Read More
Drugmakers are seeking clarification on the use of in vitro studies to assess the effects of active pharmaceutical ingredients taken by men on their potential offspring. Read More
A first-of-its-kind “basket study” of responses to Daiichi Sankyo and Genentech’s Zelboraf on a host of cancer mutations is showing positive results, Memorial Sloan Kettering Cancer Center researchers report. Read More
All sponsors planning to conduct clinical trials in Saudi Arabia for the first time must register their studies through the Saudi Clinical Trials Registry, under new guidance released in late August. Read More
Drugmakers and patient groups are pressing the FDA for more leeway on approaches to developing drugs for Duchenne Muscular Dystrophy, saying a June draft guidance doesn’t go far enough. Read More