In a new publication, CTTI applies expertise from industry sponsors, regulatory agencies, patient groups, and academic institutions to identify best practices for driving the widespread adoption of master protocols. Master protocol studies use a single protocol to guide the design and conduct of multiple sub-studies that can answer several questions at once—enabling patient-centric and efficient clinical research. Despite these benefits, adoption of master protocol studies remains limited. To facilitate broader adoption, CTTI conducted a landscape review and collected insights from multi-stakeholder expert meetings. Through these efforts, CTTI identified a broad set changes in the clinical trials ecosystem that would be needed for mainstream adoption master protocol studies: (1) the development of a harmonized global vision, (2) mobilization through the leadership of patients and academic groups, and (3) reinvention of operational processes and partnerships. The full publication, available in Clinical Trials, discusses the barriers to widespread adoption of master protocol studies and details potential solutions. The paper also highlights a suite of tools that CTTI has developed to support the design and conduct of high-quality, efficient master protocol studies.
Master Protocol Studies
Recording Now Available: The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies Public Summit
A recording for CTTI’s public summit, The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies, held Jan. 13, is now available. The summit, conducted as a webinar, opened with a welcome from Janet Woodcock, Operation Warp Speed; a call-to-action from Robert M. Califf, Verily and Google Health; and included three panel discussions focused on solutions related to scaling master protocols.
The first panel, Practical Solutions to Setting Up Master Protocol Sites, moderated by Pamela Tenaerts, CTTI, with panelists Derek Angus, REMAP-COVID; Laura Esserman, I-SPY-COVID; and Manizhe Payton, ACTIV-2, examined key challenges and potential solutions to starting up new sites including contracting, competing trials, staffing, and IRB submission.
The second panel, Increasing Participant Enrollment in Master Protocols, moderated by Esther Krofah, Faster Cures, with panelists Kousick Biswas, Veterans Health Administration; Dan Cooper, UC Irvine; and Martin Landray, RECOVERY Trial, examined the key challenges limiting participant enrollment including competition with other trials, burden on staff, and discussed potential solutions to overcome hurdles such as co-enrollment.
The final panel, Lessons for the Future, moderated by Mark McClellan, Duke-Margolis Center for Health Policy, with panelists Sam Brown, Intermountain Health System; Adrian Hernandez, PCORnet; and Saye Khoo, AGILE, discussed policy changes needed to improve future pandemic preparedness.
The public summit also addressed the status of COVID-19 clinical trials, including results from a recent CTTI analysis of data from ClinicalTrials.gov, and findings from a pre-summit survey of those involved in COVID-19 treatment master protocols, specifically those involved in setting up new sites or recruiting participants at existing sites.
View the full slide deck for the public summit to learn more from each presenter.
For additional information on CTTI’s master protocols work, please refer to this web page.
This public summit is part of a collaborative effort with the Duke-Margolis Center for Health Policy at Duke University and FasterCures, of the Milken Institute.
The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies
JANUARY 13, 2021
CTTI Project: Clinical Trial Issues Related to COVID-19
Meeting Overview:
CTTI hosted The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies Public Summit on Wed., Jan. 13. The summit, conducted as a webinar and moderated by Pamela Tenaerts, CTTI, included a welcome from Janet Woodcock, Operation Warp Speed; a call-to-action from Robert M. Califf, Verily and Google Health; and panel discussions moderated by Ester Krofah, FasterCures, and Mark McClellan, Duke-Margolis Center for Health Policy. The panel focused on solutions related to scaling master protocols, including:
- Overcoming barriers to starting up sites
- Increasing participants at existing sites
- Using the COVID experience to inform our preparedness for future pandemics
The public summit also addressed the status of COVID-19 clinical trials, including results from a recent CTTI analysis of data from ClinicalTrials.gov and findings of a pre-summit survey that offered best practices and insights from those involved in COVID-19 treatment master protocols, specifically those setting up new sites and recruiting participants at existing sites.
This public summit is part of a collaborative effort with the Duke-Margolis Center for Health Policy at Duke University and FasterCures, a Center of the Milken Institute.
Articles of Interest
- Duke-Margolis Paper Details Strategies to Treat COVID-19
- Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both (The New England Journal of Medicine)
- Complete, Rapid Reporting of Clinical Trials: A Necessary Component of the Pandemic Response (Medium)
Master Protocol COVID Treatment Resources
- Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)
- I-SPY COVID Trial
- RECOVERY - Randomised Evaluation of COVID-19 Therapy
- REMAP-CAP: A Randomised, Embedded, Multi-factorial, Adaptive Platform Trial for Community-Acquired Pneumonia
- “Solidarity” Clinical Trial for COVID-19 Treatments
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 to Host Jan. 13 Public Summit, The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies, Featuring Research & Healthcare Leaders
CTTI will host a public summit, The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies, on Wednesday, January 13. The summit, conducted as a webinar and moderated by CTTI Executive Director Pamela Tenaerts, will include a welcome from Janet Woodcock, Operation Warp Speed; a call-to-action from Robert M. Califf, Verily and Google Health; remarks from Mark McClellan, Duke-Margolis Center for Health Policy; and a panel discussion moderated by Esther Krofah, FasterCures. The panel discussion will focus on solutions related to scaling master protocols, including:
- Overcoming barriers to starting up sites
- Increasing participants at existing sites
- Using the COVID experience to inform our preparedness for future pandemics
“As we’ve learned in the global pandemic, the faster we have reliable answers, the better,” said Tenaerts. “As we look to successfully accelerate progress for COVID-19 treatments, the need for collaborative trials that supply reliable insights has never been greater and in many cases, master protocol studies can provide the solution.”
This public summit will also address the status of COVID-19 clinical trials, including results from a recent CTTI analysis of data from ClinicalTrials.gov and other research, and examine the use of common platforms to optimize the design of master protocols for multiple therapies attempting to treat the same diseases or specific health problems.
The free public summit will be held from 10:30am until noon EST.
This public summit is part of a collaborative effort with the Duke-Margolis Center for Health Policy at Duke University and FasterCures, a Center of the Milken Institute.
Recording Now Available: CTTI’s New Robust Set of Resources to Assist with Designing and Running Master Protocols
A recording is now available of the public webinar held on Tues., Oct. 13, to launch CTTI’s new set of resources that can be used to collaborate, communicate, and design master protocol studies. The webinar was led by Abby Bronson, Edgewise Therapeutics; Marianne Chase, Massachusetts General Hospital; Daniel Millar, Janssen R&D; and Nick Richardson, FDA, CDER.
While the interest in master protocol studies is growing, many organizations—particularly non-traditional drug developers such as patient advocacy groups and other nonprofits—lack the experience to design and implement this kind of study. In response to these challenges, through a high-level landscape review, a series of expert meetings, and a public open comment opportunity, CTTI developed a set of resources that include frameworks, case studies, and other interactive materials to assist in the planning and development of master protocols.
“With the success of master protocols in COVID-19 trials, there’s never been a better time to rethink the way you’re doing clinical trials in other disease areas,” said Pamela Tenaerts, executive director at CTTI. “In many cases, a well-designed and well-planned master protocol approach is an ideal way to get answers to scientific questions faster and serve patients better. Our new set of resources give sponsors, non-profit groups, and others a starting point and pathway for designing and conducting a successful master protocol study from start to finish in your disease area.”
The specific resources that CTTI released in conjunction with this webinar include:
- Value Proposition Guide: outlines key considerations for presenting the value proposition of the master protocol to stakeholders such as collaborators and vendors
- Study Simulation Tool: provides an overview of key modules that should be simulated in order to optimize master protocol design
- Protocol Development Map: describes the unique aspects of developing a master protocol from the academic or nonprofit organization perspective
- Operations Partner Assessment Tool: outlines considerations for engaging and selecting vendors as partners in master protocols
- FDA Engagement Tool: describes the formal mechanisms that facilitate early interaction with the FDA and provides a general timeline for development of an FDA engagement strategy
Both the webinar and latest resources can be found on the CTTI website.
New Resources for Designing and Running Master Protocols
CTTI Project: Master Protocol Studies
Webinar Presenters:
- Abby Bronson, Edgewise Therapeutics
- Marianne Chase, Massachusetts General Hospital
- Daniel Millar, Janssen R&D
- Nick Richardson, FDA, CDER
Webinar Resources:
- Master Protocol Design & Implementation: Charting Multi-Stakeholder Pathways to Success
- Master Protocol Content Development Guide
- Master Protocol Value Proposition Guide
- Statistical Simulation in Master Protocols: Components & Communications Considerations
- Master Protocol FDA Engagement Tool
- Master Protocol References & Resources
- Case Study: Using Central Labs in Master Protocols
- STAMPEDE Case Study: Using a Master Protocol Approach to Improve Outcomes in Prostate Cancer
- Master Protocol Studies: Emerging Best Practices to Drive Multi-Stakeholder Collaboration & Mobilization
- Master Protocol High Level Project Image
