Today, CTTI unveiled new recommendations on best practices for the use of Data Monitoring Committees (DMCs), an important approach to ensure the validity and integrity of a clinical trial when there is a need to periodically review accumulating safety and efficacy data and advise on whether to continue, modify, or terminate a trial based on the benefit-risk assessment.

CTTI recommendations are intended to enhance the functioning of a DMC, beginning with the training of members. Other issues addressed by CTTI include the role and responsibilities of the DMC, composition of members, development of a charter, and communication with the trial sponsor and others. The recommendations were presented during a session at the Society of Clinical Trials (SCT) annual meeting. Dr. David DeMets, a thought leader on DMCs, chaired a session that also included project team members Karim Calis of FDA, Raymond Bain of Merck Research Laboratories, and Annemarie Forrest of CTTI.

As noted by Dr. Calis,
“DMCs play a unique and critical role in trial oversight. The clinical trial enterprise–including investigators, sponsors, trial participants, and other stakeholders–benefits greatly from having strong, independent DMCs that have adequate resources and sufficient flexibility to carry out their important mission.”

The full recommendations are available on the CTTI website and will also be presented in a CTTI-hosted free, public webinar on June 16, 2016 from 12:00 – 1:00 PM EST (New York, GMT-04:00). See below for additional details on this upcoming webinar:

Speakers:

• Dave DeMets, PhD, Professor and Chair of the Department of Biostatistics and Medical Informatics, University of Wisconsin – Madison
• Jane Perlmutter, PhD, Patient Advocate
• Karim Calis, PharmD, MPH, FASHP, FCCP, Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

Meeting Link:  Click here to join WebEx meeting on June 16
Meeting number: 732 840 380
Meeting password: DMCctti

Or join by phone only:
1-855-244-8681 Call-in toll-free number (US/Canada)
1-650-479-3207 Call-in toll number (US/Canada)
Access code: 732 840 380

Data Monitoring Committees (DMCs) play a critical role in clinical trial conduct; however, the definition and role of a DMC are often misunderstood, even among stakeholders in the clinical trial enterprise. CTTI recommends that DMCs should be used when there is a need to periodically review the accumulating unmasked safety and efficacy data by treatment group, and advise the trial sponsor on whether to continue, modify, or terminate a trial based on benefit-risk assessment. Jane Perlmutter, patient advocate and team leader for the DMC Project, elaborates on this central theme of CTTI’s DMC recommendations:

“DMCs are something most clinical trial participants are unaware of. Yet, once a trial is approved by an IRB, DMCs are an important way to ensure that trials are proceeding in an orderly and ethical way and that the accumulating data do not suggest that the trial poses undue harm to patients.”

Given this important role of the DMC, it is imperative that they function optimally. The conduct of the DMC is largely dictated by a charter, which outlines the roles, responsibilities, and operational structure of the DMC, and should be agreed to by the sponsor and the DMC members prior to patient enrollment. Knowledge and experience of DMC members are other critical factors. New members would benefit greatly from apprenticeship or mentoring, as well as provision of case studies that illustrate challenging DMC scenarios.

The above-mentioned insights are just the beginning of a thorough examination on best practices for DMCs. CTTI’s full recommendations will be unveiled at this year’s Society for Clinical Trials (SCT) meeting. Join us for Invited Session 3 on Monday, May 16, where speakers Karim Calis, Raymond Bain, and Annemarie Forrest will reveal our recommendations. Dr. David DeMets, one of the thought leaders within the field of DMCs, will be the chair for this session. Following the unveiling, we hope you share Jane’s sentiments on the impact of our work:

“CTTI’s guidelines will help trial sponsors to follow best practices in regard to DMCs and also spur stakeholders to take measures to engage an adequate supply of diverse DMC members.”