NIH Collaboratory Grand Rounds Webinar on CTTI’s DMC Project
Data Monitoring Committees
Recording Now Available: Webinar on Best Practices for DMCs From CTTI’s Latest Recommendations
On June 16, 2016, CTTI hosted a webinar on its new recommendations on best practices for the use of Data Monitoring Committees (DMCs). This webinar provided an opportunity to learn about ways to enhance the functioning of DMCs through member training, clear roles and responsibilities, charter development, communication practices, and more. The recommendations resulted from CTTI’s DMCs Project.
We encourage you to share this recording with your colleagues in the clinical trials enterprise.
Best Practices for the Use of DMCs: Join Us for a Webinar Unveiling CTTI’s Latest Recommendations
The Clinical Trials Transformation Initiative (CTTI) invites you to participate in a webinar to learn about its new recommendations on best practices for the use of Data Monitoring Committees (DMCs), intended to enhance the functioning of a DMC, beginning with 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. CTTI’s recommendations can help 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.
- Topic: DMC Project Recommendations
- Date: Thursday, June 16, 2016
- Time: 12:00 p.m. – 1:00 p.m. EST (New York, GMT-05:00)
- Presenters:
- Karim Anton Calis, PharmD, MPH, FASHP, FCCP, Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
- Jane Perlmutter, PhD, Patient Advocate
- Dave DeMets, PhD, Professor, Department of Biostatistics and Medical Informatics, University of Wisconsin – Madison
This webinar is open to the public. We encourage you to share this invitation with others who may be interested in learning more about CTTI’s DMCs Project Recommendations.
To join:
Meeting Link: Join WebEx meeting
Meeting Number: 732 840 380
Meeting Password: DMCctti
After you connect to the website, please follow step-by-step instructions for connecting to the audio.
If you prefer to connect to audio only, you can join by phone at:
1-855-244-8681 Call-in toll-free number (US/Canada)
1-650-479-3207 Call-in toll number (US/Canada)
CTTI’s New Recommendations for Data Monitoring Committees
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
CTTI Recommendations for Data Monitoring Committees to be Unveiled at the Society for Clinical Trials (SCT) Annual
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.”
Recently Released: Expert Meeting Summary on DMC’s
On July 28 – 29, 2015, CTTI’s Data Monitoring Committee Project hosted an expert meeting. The objectives of this multi-stakeholder meeting were to:
- Present findings and conclusions from the project survey and focus groups
- Share and solicit feedback on proposed Data Monitoring Committees (DMCs) recommendations
The summary is now available online.
Participate in CTTI’s Survey on Data Monitoring Committees
We are inviting participants to a survey from the Clinical Trials Transformation Initiative (CTTI) to gather information about the current use and conduct of Data Monitoring Committees (DMCs). We aim to gain a deeper understanding of the purpose and rationale for using DMCs, goals and responsibilities of DMCs and current conduct and communications between stakeholders using this survey and future focus groups. Your input is critical as the survey results will be considered in developing recommendations on best practices for DMC use and conduct.
WHO IS BEING ASKED TO PARTICIPATE
Current and former DMC members; and representatives of research sponsors (government, industry and academic), clinical and academic research organizations (CROs/AROs) and statistical analysis centers who directly interact with DMCs. We encourage you to forward this email to qualified colleagues.
WHAT WE ARE ASKING OF YOU
You will be asked to complete one brief, electronic survey that should take less than 15 minutes to complete. The survey is anonymous; no unique identifier will link you to your responses. In this format, please note that it is therefore necessary that you finish the survey completely before exiting out of your web browser, as the survey will not save partial responses.
PLEASE CLICK ON THIS LINK TO COMPLETE THE ANONYMOUS SURVEY.
YOUR ANSWERS WILL BE TREATED CONFIDENTIALLY
We will not be able to link your personal information such as email address and name with your answers. Your answers will be combined with those from others, and we will report answers only in aggregate.
HOW YOUR INPUT WILL BE USED
The study results will be used by CTTI to develop additional investigational activities, such as focus groups and an expert meeting. Evidence gathered from these activities will support recommendations on best practices for DMC use and conduct, to be published and used to develop toolkits for the various stakeholder groups. For more information, go to https://ctti-clinicaltrials.org/our-work/ethics-and-human-research-protection/data-monitoring-committees/.
WHO WE ARE
CTTI is a public-private partnership, established by the US Food and Drug Administration (FDA) and Duke University, whose membership includes representatives from academic institutions, clinical research organizations, institutional review boards, patient groups, pharmaceutical, biological and device companies, professional societies, US government and other stakeholders within the clinical trials enterprise. CTTI conducts projects in support of its mission to identify and promote practices that will increase the quality and efficiency of clinical trials.
WHO TO CONTACT FOR QUESTIONS
You should direct any questions or concerns regarding your survey participation to CTTI (ctti-dmcproject@duke.edu). For questions or concerns about your rights as a research subject, you can also contact the Duke Institutional Review Board (IRB) at 919-668-5111.
Thank you for your consideration,
The Clinical Trials Transformation Initiative Data Monitoring Committee Project Team Leaders:
Patrick Archdeacon
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
Raymond Bain
Merck Research Laboratories
Karim Calis
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
David DeMets
University of Wisconsin-Madison
Jane Perlmutter
Patient Representative
CTTI Tackles 3 Issues in Clinical Trials with New Projects
At CTTI, we are continuously looking for practices that will increase the quality and efficiency of clinical trials. In 2014, three new topics have been added to our portfolio:
- Conducting Trials Using Data Registries: Demographic, disease, and outcome data collected in clinical observational registries often overlap with data gathered for clinical trials. Integrating clinical trials within observational data registries may offer opportunities to avoid duplicative data collection and increase efficiency while decreasing clinical trial costs. Objectives for this project include identifying upfront costs and operational adjustments required to utilize a data registry for a clinical trial, as well as recommending best practices for conducting randomized registry trials.
- Data Monitoring Committees (DMCs): As the use of DMCs has increased and evolved over the past 40 years, critical issues have emerged. A few of these issues include differences in DMC roles and responsibilities, which contributes to confusion and unclear expectations, as well as a lack of a clear plan for preparing the next generation of DMC members. Objectives for this project include understanding the current landscape of DMC use and conduct, clarifying the purpose of and rationale for using a DMC, and describing effective communication practices between independent DMCs and other trial stakeholders.
- Investigator Turnover: While an enormous amount of time and resources are spent initiating new investigators into the clinical trial process, there continues to be a high turnover rate for investigators. As many as 40% of investigators annually choose not to participate in another FDA-regulated trial. This high rate of attrition impacts site and overall trial performance. Objectives for this project include obtaining a more thorough understanding of the factors that influence investigators’ decisions to leave the clinical research practice, as well as defining the impact of investigator turnover on industry and society.