Overview
Using Master Protocol Studies to Drive Medical Product Development
Amid the COVID-19 pandemic, the value of master protocol studies has become clear: we need agile clinical trials that foster collaboration to address major public health threats and ongoing research challenges. However, the clinical research community needs more practical, detailed resources to support the design and conduct of such studies.
Working with stakeholders across the clinical trials ecosystem, CTTI is developing resources that will guide the appropriate use of master protocols, including nomenclature documents, lessons learned, and other useful materials for collaborating on, communicating about, and designing master protocol studies.
Now, through April 24, we invite members from across the clinical trials ecosystem to view and provide feedback on these draft resources. Your feedback will help shape the final materials that we make available to the public this summer. Thank you!
Quick Links to Top Deliverables
In Detail
Master protocol studies offer innovative opportunities in the design and conduct of clinical trials. The term master protocol is generally used to describe clinical trials that use one overarching protocol to guide multiple, simultaneously occurring sub-studies. Master protocol studies can be used to study multiple diseases, multiple therapies, or both.
While enthusiasm for master protocol studies is growing, the number of organizations that have sufficient experience designing and implementing master protocol studies remains critically low. Several organizations have provided opportunities for stakeholders to learn general information about master protocol studies. Efforts are needed to build off this important work to create practical, detailed resources to support the design and conduct of master protocol studies.
Master Protocol Studies: Opportunities, Challenges, and Emerging Best Practices (“Master Protocol Studies”) (2019 – ongoing)
- Compare and contrast the distinct design and operational features of basket, umbrella, and platform trials.
- Identify emerging best practices for the design and conduct of master protocol studies.
CTTI’s work will increase the appropriate use of master protocol studies.
- A landscape review – Expert interviews and a literature scan will be used to develop a high-level roadmap that details strategies to address common roadblocks that inhibit the development of master protocol studies at the pre-planning, planning, or execution stage.
- An Expert Meeting series – This will be used to identify emerging best practices and prioritize the creation of tools to support stakeholders’ efforts to address common challenges related to the design and implementation of master protocol studies.
Project Team Members
Role |
Name | Affiliation |
|---|---|---|
| Team Member | Sabrina Paganoni | Harvard University |
| Team Member | Jane Perlmutter | Individual Patient/Caregiver |
| Team Member | Natasha Phrsai | Feinstein Institute for Medical Research |
| Team Member | Dionne Price | Food and Drug Administration |
| Team Member | Paulina Selaru | Pfizer, Inc. |
| Team Member | Antonia Valakas | EMD Serono |
| Team Member | Gene Vinson | Syneos Health |
| Team Member | Alain Vuong | GlaxoSmithKline |
| Team Member | Kirsty Wydenback | Medicines and Healthcare Products Regulatory Agency (MHRA) |
| Team Member | Kert Viele | Berry Consultants |
| Team Member | Michelle Detry | Berry Consultants |
| Team Member | Elena Kovalenko | Novartis |
| Team Member | Abby Bronson | Parent Project Muscular Dystrophy |
| Team Member | Christine Mayer-Nicolai | EMD Serono |
| Team Member | Nina Selaru | Pfizer, Inc |
| Team Member | Pamela Tenaerts | Clinical Trials Transformation Initiative |
| Team Member | Angie Botto-van Bemden | Arthritis Foundation |
| Team Member | Louise Brown | University College London |
| Team Member | Amy Burd | Leukemia & Lymphoma Society |
| Team Member | Paul Bycott | Pfizer, Inc. |
| Team Member | Karen Dimick | Genentech - a member of the Roche Group |
| Team Member | Hans-Juergen Fuelle | Novartis |
| Team Member | Emma Healy | Novartis |
| Team Member | Ritesh Jain | EMD Serono |
| Team Member | Nicholas Kenny | Syneos Health |
| Team Member | Barbara LeStage | Individual Patient/Caregiver |
| Team Member | Roger Lewis | University of California, Los Angeles |
| Team Member | Greg Licholai | Yale University |
| Team Member | Sharon Love | University College London |
| Team Member | Sumithra Mandrekar | Mayo Clinic |
| Team Member | Debra Michaels | DIA |
| Team Lead | Rajeshwari Sridhara | Food and Drug Administration |
| Team Lead | Marianne Chase | Harvard University |
| Team Lead | Daniel Millar | Janssen Pharmaceuticals |
| Team Lead | Shenghui Tang | Food and Drug Administration |
| Team Lead | Nicholas Richardson | Food and Drug Administration |
| Project Manager | Kim Fisher | Clinical Trials Transformation Initiative |