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.
The FDA is working on a number of projects designed to lower clinical trial costs and speed up trial times, a top FDA official told conference-goers at the Society for Clinical Research Sites’ 2014 Site Solutions Summit. Read More
Sponsors seeking to enroll patients in studies of treatments for invasive aspergillosis may use the presence of the molecule galactomannan as a probable indicator of the infection, under an FDA program to qualify biomarkers used in drug development.
Read More
Drug sponsors need to find more thoughtful, comprehensive ways of recording and integrating patient outcomes data into their efficacy analyses, but long questionnaires may not be the solution, a top FDA official says.
Read More
Manufacturers of interventional cardiovascular devices may benefit from holding their first clinical trials in Europe, a clinical research organization advises. Read More
Sponsors need to do a better job of understanding disease and disability conditions and aligning that knowledge with measures for patient-reported outcomes. Read More
Sponsors of clinical trials for new migraine therapies should focus on enrolling more women of childbearing age, as more women than men suffer from migraines, according to FDA draft guidance on trial design expectations for the pain drugs. Read More
A new Society for Clinical Research Sites white paper outlines a set of best practices that members of industry group TransCelerate hope will eventually help clinical trial sites improve their compliance. Read More
Clinical trial sites need to brush up on their good clinical practice training specs and shouldn’t expect sponsors to compensate them for doing so, says Christine Pierre, president of the Society for Clinical Research Sites. Read More
The FDA is strengthening its bioresearch monitoring program as part of a sweeping plan to overhaul its approach to inspections and regulatory monitoring. Read More
Access to a forthcoming clinical trials portal and database would be limited to authorized users and “super users,” under draft specifications released by the European Medicines Agency. Read More
Researchers looking to study the safety and effectiveness of medical devices should tailor their trials to the requirements of the specific technology, a report by the Dutch Royal Academy of Sciences concludes. Read More