Transparency in clinical trials is continually changing, and to stay on top of the news, TrialAssure brings a weekly round-up of some of the key stories surrounding disclosures in clinical trials. This week’s stories are as follows:
FDA Commissioner Warns of Shutdown’s Impact on Clinical Trials – CenterWatch
As the partial government shutdown entered a record-setting fourth week, FDA Commissioner Scott Gottlieb said it was no longer “business as usual” at the agency — calling the shutdown “one of the most significant operational challenges in FDA’s recent history.”
Get the details on CenterWatch.
FDA is urged to mandate disclosure of clinical trial summaries as pilot program stalls – STAT
Since launching a pilot program to release clinical study reports (CSRs) one year ago, only one organization has submitted information. Critics are labeling the program as stalled and calling for this program to become a mandatory requirement.
Read the full article here.
Trial Transparency: NIH Says Final Rule From 2017 has Helped – RAPS.org
One year ago to the day – January 18, 2017 – the Final Rule took effect, and since then, the National Institutes of Health (NIH) said that progress has been made as “registration and results submissions to ClinicalTrials.gov continues to grow.” They go on to say that “with continued outreach and education and additional organizational efforts, rates of reporting will continue to increase.”
Read the full article by Zachary Brennan.