Novel Endpoints
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 Presents on Patient & Provider Attitudes on Streamlined Antibacterial Drug Development at ATS 2016
Resistance to available antibiotics is increasing. Despite the critical need for novel antibacterial therapies, their development is lagging. At the 2016 American Thoracic Society (ATS) International Conference, Deborah Collyar, a project team member for CTTI’s Unmet Need in Antibiotic Development Project, will present results from interviews and focus groups on patient and provider attitudes toward using streamlined approaches for antibacterial drug development. These findings will be used to develop recommendations to improve the uptake and appropriate use of antibacterial therapies that are developed through streamlined approaches to address the critical unmet need for novel antibacterial therapies.
If you are attending the conference, please stop by to learn more:
ATS 2016 International Conference Conference
Location: San Francisco, California
Poster: Streamlining Antibacterial Drug Development Programs to Address Unmet Medical Need: Patient and Provider Attitudes on a Modified Benefit-Risk Calculus
Date & Time: Sunday, May 15, 2016, from 9:00 AM-4:15 PM PT
Presenter: Deborah Collyar
CTTI Reveals Findings from Pediatric Antibiotic Trials Project at PAS 2016
Conducting antibacterial trials in pediatric populations has unique challenges, which have contributed to the overall complexity of antibacterial drug development. CTTI’s Pediatric Antibiotic Trials Project aims to identify barriers related to scientific and operational issues in the design and conduct of clinical trials of antibacterial drugs for children, as well as develop recommendations to address these challenges.
After conducting surveys with investigators of pediatric antibiotic clinical trials and community providers, conducting qualitative interviews with parents and industry representatives, and reviewing information in the ClinicalTrials.gov database, we now have a body of evidence to inform this discussion. Findings indicate a multiplicity of real and perceived modifiable barriers to participating in or conducting pediatric antibacterial clinical trials, the need for deeper engagement with parents, and the necessity of effective recommendations to improve the design and conduct of these trials. These findings will be presented at the Pediatric Academic Societies (PAS) 2016 Meeting in Baltimore, MD on April 30 – May 3, 2016.
Poster Topic: Pediatric Trials in Antibacterial Drug Development: Findings from the Clinical Trials Transformation Project
Location: Exhibit Hall F
Date & Time: Saturday, April 30, 2016, from 1:30 – 2:45 PM EST
Speaker: Brian Smith, Duke University School of Medicine
CTTI Acknowledged for Contributing to FDA Sentinel Program in Applied Clinical Trials News Article
The Food and Drug Administration’s (FDA) Sentinel program was launched in 2008 and has been a considerable investment for the FDA, as indicated by Janet Woodcock in a recent Applied Clinical Trials news article. The Sentinel system is an important part of routine safety surveillance for pharmaceuticals and other medical products. The FDA plans to expand use of the Sentinel system to public health and quality improvement activities as well as effectiveness research in its “Guardian” system.
CTTI supported FDA efforts to explore the potential for using the Sentinel database beyond safety surveillance previously; CTTI and FDA’s Mini-Sentinel jointly published a report describing the capability and willingness of Mini-Sentinel’s Data Partners to collaborate in a variety of types of randomized trials, using the Mini-Sentinel (now Sentinel) Distributed Dataset. CTTI and Sentinel are now collaborating to design and implement a trial based on findings in the report. As mentioned in the recent Applied Clinical Trials news article, CTTI will facilitate the development and execution of a protocol for a randomized trial (IMPACT-AF) to study an educational intervention to improve the appropriate use of anti-coagulation for atrial fibrillation. This trial is a proof of concept study intended to determine whether it is possible to conduct a trial within the “Guardian” system. CTTI is proud to support the FDA’s efforts to expand their safety monitoring system to become a national resource with broader applications, specifically in more real-world clinical studies.
A Brave New World: Registry-Based Clinical Trials
MARCH 30, 2016
CTTI Project: Registry Trials
Meeting Objectives
- Identify essential elements of registries needed to successfully embed and conduct registry-based clinical trials
- Present findings from CTTI’s Registry Trials Project: 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
Meeting Location:
DoubleTree Silver Spring Hotel by Hilton, 8727 Colesville Road, Silver Spring, MD 20910
Meeting Presentations:
- Introduction by Stephen Mikita, JD
- Introduction to CTTI by Sara Calvert
- Registry Trials Project Overview and Scope by Stephen Mikita, JD
- Regulatory Pathways: Devices vs. Drugs Are there roles for registries? by John Laschinger, MD
- CTTI Registry Trials Project: Literature Review by Sara Calvert
- Registry Trials Project Expert Interviews by Ted Lystig
- Registry-based RCTs: What we learned from the TASTE Trial by Ole Fröbert, MD, PhD, FESC
- Utility of Industry-Sponsored Oncology Registries For Clinical Trials – A Perspective by E. Dawn Flick, RPh MPH ScD
- Registry Trials VA Point of Care Trial and Precision Oncology Programs by Louis Fiore
- Registry Trials Breakout Sessions Report Outs
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.
Materials from CTTI’s Unmet Need in Antibiotic Development Meeting Now Available
On March 1, 2016, CTTI hosted an expert meeting entitled, The Use of Antibacterial Drugs Developed via Streamlined Approaches for Serious Infections Where There is Unmet Need: Understanding Patient and Physician Perspectives and Considerations to Take Forward. We are pleased to now share the meeting materials online, including the presentations, agenda, and attendee list.
This meeting was associated with the Unmet Need in Antibiotic Development Project. A variety of stakeholders attended, including academia, clinical experts, patient advocates, regulators, pharmaceutical companies, and others involved in the clinical research enterprise. The meeting objectives were to:
- Present perspectives from patients, caregivers and physicians on antibacterial drugs developed using streamlined approaches
- Identify focus group themes and discuss topics which should be further explored or where draft recommendations could be made
- Obtain feedback to improve labeling, risk communication, public understanding and stewardship
Now Available: Poster on Cost Drivers of HABP/VABP Phase 3 Clinical Trials
On October 9, 2015, results from CTTI’s Streamlining HABP/VABP Trials Project were presented in the poster session, Cost Drivers of Hospital Acquired Bacterial Pneumonia and Ventilator Associated Bacterial Pneumonia (HABP/VABP) Phase Three Clinical Trials, at ID Week 2015 in San Diego, CA. This poster explores the drivers of HABP/VABP direct and indirect clinical trial costs and identifies opportunities to lower these costs.