Formats
Registry-Based Clinical Trials: Expert Meeting Materials Now Available
On March 30, 2016, CTTI’s Registry Trials Project held a multi-stakeholder expert meeting to accomplish the following:
- Identify essential elements of registries needed to successfully embed and conduct registry-based clinical trials
- Present findings from the project’s literature review and expert interviews
- Receive feedback on potential benefits of and existing barriers to the use of registries in clinical trials
- Reach consensus on best practices to increase adoption of clinical trials within registries
The meeting included more than 40 participants from academia, government agencies, industry, and patient representatives. A key takeaway was that a role exists for registries in creating a sustainable infrastructure to conduct regulatory trials, including early development, pre-market, and post-approval investigations. Suggestions were generated around considerations including data quality, regulatory issues, governance, and registry design. Input from the meeting, along with evidence gathered through the CTTI project, will be used to develop recommendations and tools to increase the value, acceptance, and success of registry-based clinical trials.
CLICK HERE to access the meeting summary, slides, agenda, and other materials.
CTTI’s New Website Features Content to Improve Clinical Trials
In furtherance of our quest to drive adoption of practices that will increase the quality and efficiency of clinical trials, CTTI has launched a new website that provides easy access to recommendations and tools that can lead to better clinical trials.
What’s new?
- CONTENT NOW ORGANIZED BY TOPIC: The new website packages CTTI’s robust portfolio of work into intuitive, easy-to-navigate topics, such as central IRBs and recruitment.. Within each topic, the new layout gives prominence to critical content, including latest news and most used resources.
- OPTIMIZED, RESPONSIVE LAYOUT: The updated design features a responsive layout, which will optimize the visitor’s experience across devices and browsers.
- NEW URLs: New URLs will exist for the project and program pages, but don’t worry! We are setting up re-directs to make this transition as seamless as possible for you. This means that the old URLs will still work, but cleaner, more direct URLs will exist for content related to projects and programs.
If you are having issues locating content, you can:
- Try the search bar, located in the top right corner of our site
- Email our communications specialist, Noel Benedetti (noel.benedetti@duke.edu)
We welcome your feedback on the new site. If you have any suggestions for improvement, please send your thoughts to Noel. Thank you for your patience and input as we continue to improve your access to resources that help drive change 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)
FDA and CTTI to Collaborate on New Patient Engagement Initiative
The FDA and the Clinical Trials Transformation Initiative (CTTI) will be collaborating to establish a new external work group related to patient engagement at the FDA. The FDA has long involved patients and considered patient perspectives in its work. This new initiative is part of the FDA’s continued commitment to fostering greater patient participation and input in regulatory medical product matters. Stakeholders suggested an external work group as a way for FDA to enhance patient engagement (View Report).
The FDA will leverage CTTI’s strengths in multi-stakeholder engagement to coordinate the new work group. CTTI, a public-private partnership, has a strong community of patient advocates and caregivers within its membership. The new work group will create a forum to exchange information, ideas, and experiences on matters of interest to patients and patient advocates related to patient engagement at the FDA. The work group will be similar to the European Medicines Agency’s Patients’ and Consumers’ Working Party, which marks its 10th anniversary in June 2016.
Additional details will be released as the work group develops.