Supporting Data Monitoring Committees
Use of independent Data Monitoring Committees (DMCs) for clinical trials has grown dramatically and continues to expand. Sponsor companies - in all therapeutic areas - are increasingly tasked to form committees, write then adhere to a charter, the study protocol and all regulatory requirements.
The FDA Guidance for the Establishment and Operation of Clinical Trial Data Monitoring Committees recommends the formation of DMCs for studies with possible early termination for efficacy or futility, studies with invasive treatments, studies with serious toxicities or mortality endpoints, studies involving fragile populations, and large long-term multi-center studies.
[fa icon="thumb-tack"] Current FDA guidance on Independent Data Monitoring Committees
Cytel supports independent DMC's by:
- Providing qualified statisticians to serve on the DMC
- Recommending committee personnel with the necessary therapeutic expertise, experience
- Assisting with the creation of the DMC charter
- Serving as the Independent Statistical Center producing unblinded DMC safety and efficacy reports
Cytel has provided and continues to support DMCs across a wide range of therapeutic areas including oncology, cardiology, CNS, metabolic disease, infectious disease, pain and arthritis.
Our customers have also implemented ACES regulatory compliance assurance system to comply with FDA and EMA guidelines by securing communications and data access between sponsor and independent committee.
With a combination of interim analysis process knowledge, wide experience, and proven technology, Cytel's expertise in this crucial area is unrivalled.