article thumbnail

How using AI in clinical trials accelerates drug development

Pharmaceutical Technology

During these phases, data is obtained from participants and monitored for adverse reactions or changes to health indicators, such as blood pressure or heart rate. For example, important information may be locked in knowledge silos or gained through experience, making it difficult to find or document.

article thumbnail

How to Run DMC? It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials

The FDA Law Blog

Other Oversight Groups Both documents described the role of other oversight groups, in addition to DMCs, that may be involved in a clinical trial in similar, sometimes overlapping, roles such as IRBs, trial steering committees, and site monitors. Increased Connections Between a DMC and FDA?