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Last week, the U.S. Food and Drug Administration (FDA) published a draft guidance on the use of data monitoring committees (DMCs) in clinical trials entitled “Use of Data Monitoring Committees in ...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FDA Issues Draft Guidance on Use of Data Monitoring Committees in Clinical Trials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

Drug Monitoring Committee Authorizes Continuation of Intensity Therapeutics' Ongoing Global Randomized Phase 3 Sarcoma Trial ("INVINCIBLE-3 Study") Following Periodic Review

INVINCIBLE-3 Study continues to recruit patients with leiomyosarcoma, liposarcoma and undifferentiated pleomorphic sarcoma; authorizations for the INVINCIBLE-3 Study have been received in the U.S., ...
Morningstar

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

Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company specializing in the development of novel therapies to restore, treat and prevent hearing loss disorders, today ...
National Institute for Health and Care Excellence

Pulmonary artery pressure technologies for remote monitoring of chronic heart failure

The diagnostics advisory committee considered evidence on pulmonary artery pressure (PAP) technologies for remote monitoring of chronic heart failure from several sources. This included evidence ...