Assessing Interim Trial Safety, Efficacy and Integrity

Clinical Trial Decision Making with DMC's (DSMB's)

Independent of the sponsor, Data Monitoring Committees (DMCs, aka, Data Safety Monitoring Boards or DSMBs) makes assessments of interim trial safety, efficacy and integrity information.

Comprised of a team of trial experts, the DMC is charged with examining the interim clinical data and making unbiased recommendations for the continuation, alteration and termination of the trial.

Increasingly requested by regulators, DMC use is on the rise with drug, biologic and device study sponsors to ensure study validity. Incorporating a DMC further protects against proceeding with an unsafe product or futile trial, mitigating the risks to trial patients and optimizing resource utilization for the sponsor.

DMCs are most common in late stage, confirmatory trials, but can also be instituted in earlier studies and seamless trials, especially when safety or population concerns warrant.

Cytel's DMC Membership Experience

A DMC's ability to provide the anticipated additional assurance of patient safety and trial integrity depends greatly on the knowledge of the committee members.

Cytel's biostatisticians have served on DMC committees for numerous pharmaceutical and biotechnology companies for trials in oncology, cardiology, arthritis, multiple sclerosis, dermatology, metabolic diseases and bone fracture.

DMC Services

In addition to DMC committee membership, Cytel's Clinical Research Services helps sponsors successfully establish and manage DMCs by providing:

• An independent statistical center providing unblinded data analyses and summary reports for the DMC closed sessions
• Committee charter preparation: DMC-sponsor interaction protocols, review of committee structure, meeting logistics, ethical and patient considerations
• DMC structure and function guidance: based on the trial's statistical design and the study objectives, who should serve and what are their duties?
• Communication of trial design concepts and study objectives, including stopping boundary definitions and rules for futility
• Strategies for data access and analyses standard procedures (SOP formulation)
• Management of potential interactions with IRBs, safety, regulatory or regional authorities
• Effective implementation of DMC recommendations to the on-going trial

Adaptive Trials and DMC's: Invited Talks by Cytel Experts

"Data Monitoring Committees in the Adaptive Era - Practical and Statistical Implications"
2008 US DMC Conference session presentations by Cytel President and Co-Founder Cyrus Mehta

"MAKNG DECISIONS FROM DMC RECOMMENDATIONS: Evaluating the DMC Recommendations and Effectively Incorporating them into the Clinical Trial"
October 2008 European DMC conference invited speaker Judith Quinlan, Cytel VP Adaptive Trials