Ethics
JAMA Publishes CTTI’s Recommendations for Data Monitoring Committees
An 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
CTTI 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.
New NIH Policy Aligns With CTTI’s Work to Increase Adoption of Central IRBs
The NIH has issued a final policy requiring the use of a single institutional review board (IRB) for multi-center NIH-funded clinical trials. The policy will take effect May 25, 2017.
Since 2010, CTTI has been working to address barriers to the adoption of central IRBs for multi-center clinical trials through its Central IRB and subsequent Central IRB Advancement projects. The draft NIH policy released in 2014 referenced CTTI’s recommendations, and the final policy reflects CTTI’s shared goal to increase the efficiency of clinical trials through the use of central IRBs.
With the NIH mandate now finalized, CTTI’s tools are available to help with implementation. These include the following:
- a template IRB authorization agreement
- an evaluation checklist with considerations for 1) assessing an institution’s readiness for central IRB adoption, 2) selecting a central IRB, and 3) deciding when a central IRB should work with a specific institution
- a considerations document to address the often blurred distinctions between responsibilities for ethics review and other institutional obligations
According to the new policy, “while the NIH anticipates that there will be challenges associated with implementation, we expect these to be short-lived. Once the transition to the new way of operating is made, the benefits of widespread use of [single IRBs] will outweigh any costs and, ultimately, reduce burdens to the research process.”
CTTI applauds this important progress for the clinical trials enterprise.
Recording Now Available: Webinar on IND Safety Reporting
Are you confused about how best to comply with the FDA final rule on IND safety reporting? Would you like to hear more about how to handle common, yet challenging, safety reporting situations?
We invite you to view the recording from CTTI’s webinar, which explored challenging safety reporting scenarios using case studies. Presenters from CTTI’s IND Safety Advancement Project Team included representatives from CTTI, FDA, and industry.
To view recommendations and publications from CTTI’s IND Safety Advancement Project, CLICK HERE.
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)