News

For years, Duchenne muscular dystrophy drug trials included a specific endpoint requiring that they enroll only patients who were still able to walk. That changed when a DMD-focused advocacy organization took the matter up with the FDA and helped develop new trial guidelines.

The festivities marking the late 2019 holiday season in Europe have been spoiled by a disconcerting message about the declining efficiency of investments in pharmaceutical research, in the shape of a lengthy report from the European Union on industry’s innovative capacity.

The need for efficient and timely development of new treatments for multiple serious conditions will drive efforts to modernize clinical research in the coming year.

The European Union system for pharmacovigilance “is operating effectively and efficiently” concludes a report.

The latest happenings in the clinical trials industry from the past month, all in one place.

FDA has an official new leader, following a Senate vote to confirm Stephen Hahn as the agency’s next commissioner.

David Arthur, CEO of Salarius, discusses how companies like Salarius are incorporating endpoints into early-stage clinical trials that could offer a glimpse into efficacy.

Doug Manion, CEO of Kleo, explains how platform technology essentially involves the engineering of antibodies and biologics using linear process chemistry to enhance drug effectiveness.

CISCRP – in partnership with 10 leading pharmaceutical companies and clinical research service providers – has launched a new consortium that will focus energy and resources on community-based education to improve clinical trial diversity.

How sharing patient data drives trial engagement and honors patient contributions to the research process.