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Last week, the U.S. Food and Drug Administration (FDA) published a draft guidance on the use of data monitoring committees (DMCs) in clinical trials entitled “Use of Data Monitoring Committees in ...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 [email protected]. 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FDA Issues Draft Guidance on Use of Data Monitoring Committees in Clinical Trials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 ...
Business Insider

Actinogen receives positive Interim Analysis recommendation from its independent Data Monitoring Committee to continue the XanaMIA pivotal Alzheimer’s disease trial

SYDNEY, Feb. 03, 2026 (GLOBE NEWSWIRE) -- Actinogen Medical Limited (ASX: ACW) announces that the XanaMIA pivotal Alzheimer’s disease (AD) trial’s independent Data Monitoring Committee (DMC) has ...
Seeking Alpha

Independent Data Monitoring Committee Recommends Initiation of Cohort 2 at the Increased Dose of 12 mg/kg in Entrada Therapeutics’ ELEVATE-44-201 Study

-- Company on track to report ELEVATE-44-201 Cohort 1 data in Q2 2026, with Cohort 2 data by end of year -- “We are pleased that after reviewing the Cohort 1 data from our ELEVATE-44-201 study, the ...
Seeking Alpha

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. (SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel ...
RAPS

Q&A on Data Monitoring Committees: EMA Drafts Consultation

The European Medicines Agency (EMA) last week opened a consultation on a new question and answer document on data monitoring committees. The seven questions and answers deal with whether DMC ...
RAPS

EMA offers new Q&A on data monitoring committees

The European Medicines Agency (EMA) on Thursday released a new guideline offering nine questions and answers on issues related to the role of data monitoring committees (DMCs) in the conduct and ...
Nasdaq

SELLAS Life Sciences Announces Positive Recommendation from the Independent Data Monitoring Committee of the Phase 3 REGAL Trial in Acute Myeloid Leukemia

NEW YORK, June 17, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of ...
MedPage Today on MSNOpinion

Real-time trial review needs a response plan, not just a data feed

Three recommendations for response-side standards before the pilot is scaled ...
Business Wire

Sensorion Receives Positive Recommendation from Data Monitoring Committee of SENS-501’s Audiogene Phase 1/2 Clinical Trial

MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News: Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company specializing in the development of novel therapies to restore, ...