Data Monitoring Committees

CTTI Data Monitoring Committees Project Expert Meeting

JULY 28, 2015 TO JULY 29, 2015

CTTI Project: Data Monitoring Committees (DMCs)

Meeting Objectives

  • Present findings and conclusions from the project survey and focus groups
  • Share and solicit feedback on proposed Data Monitoring Committees (DMCs) recommendations

Meeting Location:

DoubleTree by Hilton Hotel Washington, D.C., Silver Spring, MD

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

Click here to view the presentation slides from this meeting.

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

CTTI Recommendations on Best Practices for the Use of DMCs

CTTI Project: Data Monitoring Committees (DMCs)

Webinar 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

Webinar Objectives:

This webinar covers CTTI's 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.

CTTI Publishes Recommendations to Enhance Data Monitoring Committees

Posted on by Lorri Bingham

Improve trial oversight by applying best practices for DMC setup and operation

CTTI has published recommendations to enhance the functioning of data monitoring committees (DMCs) for clinical trials. Sponsors, DMC members, and all those involved in clinical trial design and conduct can apply CTTI’s recommendations to improve DMC operation and the quality of trial oversight, which ultimately benefits patients.

The monitoring of accumulating data in a clinical trial helps to ensure participant safety, as well as the validity and integrity of the trial. For an increasing number of trials, this is accomplished through an independent DMC that can advise on whether to continue, modify, or terminate a trial based on a benefit-risk assessment. Though DMCs play an important role in the oversight of clinical trials, there is considerable variability in how they are composed and operate.

CTTI’s recommendations, which appear in the journal Clinical Trials, address the following areas:

  • Clarifying the role of DMCs
  • Best practices for DMC conduct
  • Effective communication practices
  • Strategies for preparing the next generation of DMC members

The recommendations were developed through a consensus of experts from multiple stakeholder groups after collecting and analyzing data on DMC practices.

Learn more about CTTI’s Data Monitoring Committees Project.

CTTI Leads Workshop and Shares Findings at International Meeting on Clinical Trials

Posted on by Lorri Bingham

LOOK FOR US AT SCT ICTMC 2017 IN LIVERPOOL FOR STRATEGIES TO IMPROVE THE QUALITY AND EFFICIENCY OF CLINICAL TRIALS

You’re headed to Liverpool, take this printable one page schedule of CTTI’s presentations at the meeting. See you there!

CTTI will present its recommendations and latest findings in five sessions at the International Clinical Trials Methodology Conference (ICTMC) and Society for Clinical Trials (SCT) Annual Meeting, May 7-10, 2017. We will lead a hands-on workshop on best practices for Data Monitoring Committees, and share our evidence and strategies on embedding randomized clinical trials within registries, developing novel endpoints generated by mobile technology, and more.

Session Title: Formative Research Findings on the Design of an Early Enrollment Clinical Trial on Hospital Acquired Bacterial Pneumonia (HABP) and Ventilator Associated Bacterial Pneumonia (VABP) (Parallel Session 1.5 – Qualitative Research)
Date & Time: Monday May 8 from 1:30–2:30 p.m.
Speaker: Amy Corneli, Duke University
Related CTTI Project: HABP/VABP Studies

Post/our-work/novel-clinical-trial-designs/antibiotic-drug-development/abdd-habp-vabp-studies/er Abstract: Embedding Randomized Clinical Trials within Registries: How Feasible? (Poster Board #152)
Date & Time: Monday, May 8 from 3:40–4:25 p.m.
Speaker: Ted Lystig, Medtronic
Related CTTI Project: Registry Trials

Poster Abstract: Developing Novel Endpoints Generated by Mobile Technology for Use in Clinical Trials: A Clinical Trials Transformation Initiative (CTTI) Project (Poster Board #153)
Date & Time: Monday, May 8 from 3:40–4:25 p.m.
Speaker: Martin Landray, University of Oxford
Related CTTI Project: MCT Novel Endpoints

Workshop Title: Data Monitoring Committees: Multi-stakeholder Recommendations and Hands-on Experience from CTTI and the MRCT Center (Workshop 3)
Date & Time: Tuesday, May 9 from 8:30–10:00 a.m.
Speaker: Annemarie Forrest, CTTI
Related CTTI Project: DMCs

Panel: Clinical / Outcomes Registry-Based Randomised Controlled Trials – The Future for Clinical Trials? (Invited Session 3.5)
Date & Time: Tuesday, May 9 from 8:30–10:00 a.m.
Speaker: Ted Lystig, Medtronic
Related CTTI Project: Registry Trials

Happy Holidays from CTTI – Gifts you can use

Posted on by Lorri Bingham

Happy Holidays

If quality, efficient trials are on your wish list, we’ve got you covered.

CTTI’s latest recommendations and tools:

In 2016, there were over 30,000 downloads from the CTTI website. Popular favorites include our evidence-based recommendations on trial quality, informed consent, and patient group engagement.

By engaging all stakeholders to develop actionable solutions, we are creating a better system for clinical trials. Thank you to all of our members and contributors for their efforts this past year, and best wishes for a successful 2017!

JAMA Publishes CTTI’s Recommendations for Data Monitoring Committees

Posted on by Lorri Bingham

New PublicationsAn article describing key points from CTTI’s Recommendations for Data Monitoring Committees (DMCs) appears in this week’s edition of JAMA. As independent bodies able to review accumulating data for ongoing clinical trials, DMCs fulfill a unique and vital role in ensuring the scientific integrity and safety of clinical trials.

The article details the following:

  • The unequivocal need for DMCs to review unmasked data
  • The importance of DMCs reviewing safety and efficacy data together
  • Appropriate qualifications for DMC members

With the growing use of DMCs for trial oversight, these evidence-based best practices for DMC establishment and conduct can help ensure proper DMC functioning to fulfill their mission. CTTI is pleased to see these recommendations reach a broad audience and is encouraging widespread implementation.

View CTTI’s complete recommendations for additional consensus-driven best practices for DMCs.

To learn more about CTTI’s DMCs Project, CLICK HERE.

New Insights on Data Monitoring Committees Published in Clinical Trials

Posted on by Lorri Bingham

New PublicationCTTI has published a new article in Clinical Trials, Understanding the Functions and Operations of Data Monitoring Committees: Survey and Focus Group Findings.

This article shares insights gathered from research with clinical trial sponsors, data monitoring committee (DMC) members, regulators, and other stakeholders. The results were used in the development of CTTI’s official recommendations to improve the functioning of DMCs and quality of trial oversight.

Read this publication for key findings in the areas of:

  • The role of DMCs and when they are needed
  • Typical DMC composition and methods for identification of members
  • Practices for DMC charters, member contracts, and meetings
  • Methods for enhancing DMC communications
  • Views on DMC member qualifications and ways to develop training

To learn more about CTTI’s DMCs Project, CLICK HERE.