Data Monitoring Committees

Participate in CTTI’s Survey on Data Monitoring Committees

Posted on by Lorri Bingham

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

Posted on by Lorri Bingham

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:

  1. 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.
  2. 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.
  3. 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.