JD Supra

How to use a Data Monitoring Committee in clinical trials: FDA invites industry comment

Last week, the U.S. Food and Drug Administration (FDA) published a draft guidance on the use of data monitoring committees (DMCs) in clinical trials entitled “Use of Data Monitoring Committees in ...
Healio

Data monitoring committee OKs continuation of phase 3 trial for vidofludimus calcium

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. An independent data monitoring committee has ruled that ...
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, ...
JD Supra

FDA Issues Draft Guidance on Use of Data Monitoring Committees in Clinical Trials

A major shift in FDA’s current thinking, in comparison with the 2006 guidance, is heightened emphasis in the Agency’s view that DMC assessment of interim safety data alone is not sufficient. FDA ...
Nasdaq

SELLAS Life Sciences Announces Independent Data Monitoring Committee Periodic Review and Positive Recommendation to Continue Pivotal Phase 3 REGAL Trial of GPS in AML Without ...

NEW YORK, Aug. 07, 2025 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of ...
Seeking Alpha

Relmada Therapeutics Reports That Data Monitoring Committee (DMC) Assessment Indicates That the Phase 3 Reliance II Trial is Futile at its Interim Analysis and is Unlikely to ...

Relmada is well capitalized with approximately $54.1 million in cash and cash equivalents as of September 30, 2024 CORAL GABLES, Fla., Dec. 04, 2024 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc.
Business Wire

Independent Data Monitoring Committee Recommends Continuing the Trial Evaluating Temelimab in Long COVID Without Any Modifications

GENEVA--(BUSINESS WIRE)--Regulatory News: GeNeuro (Euronext Paris: CH0308403085 - GNRO), a biopharmaceutical company focused on stopping causal factors driving the progression of neurodegenerative and ...
Nasdaq

Theriva Biologics Announces Positive Recommendation from the Independent Data Monitoring Committee of VIRAGE, the Phase 2b Clinical Trial of VCN-01 in Combination with ...

The independent data monitoring committee (IDMC) recommended the continuation of VIRAGE with no safety concerns raised; VIRAGE remains on track to complete enrollment in the first half of 2024 ...