Nature

Data Monitoring Committees in Clinical Trials

Data Monitoring Committees (DMCs) play a pivotal role in safeguarding participant safety and ensuring the integrity of clinical trials. Operating independently from trial sponsors and investigators, ...
Seeking Alpha

Theriva™ Biologics Announces Positive Outcome of Data and Safety Monitoring Committee (DSMC) Review in Phase 1b/2a Clinical Trial of SYN-004 (ribaxamase) in Allogeneic ...

ROCKVILLE, Md., Oct. 03, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics, Inc. (NYSE American: TOVX), (“Theriva” or the “Company”), a diversified clinical-stage company developing therapeutics designed to ...
JD Supra

FDA Releases Guidance on Data Monitoring Committees for Clinical Trial Management

The US Food and Drug Administration (FDA) recently issued draft guidance with recommendations to help clinical trial sponsors determine when a data monitoring committee (DMC) would be beneficial for ...
Nasdaq

Achieve Life Sciences Announces Positive Outcome of Second Data Safety Monitoring Committee Review for the ORCA-OL Clinical Trial

SEATTLE and VANCOUVER, British Columbia, Feb. 10, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development ...
JD Supra

FDA Releases New Draft Guidance Regarding Clinical Trial Data Monitoring Committees

The U.S. Food & Drug Administration (FDA) released a new proposed draft guidance in February that would change the FDA’s outlook on the engagement of a data monitoring committee (DMC) in clinical ...