Using Master Protocol Studies to Drive Medical Product Development
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.
Working with stakeholders across the clinical trials ecosystem, CTTI developed a robust set of resources that guide the appropriate use of master protocols, including a:
Additionally, specific to the pandemic, CTTI led a panel discussion, “The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies," highlighting results from an analysis of data from ClinicalTrials.gov, as well as best practices and insights from those involved in COVID-19 treatment master protocols.
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)
CTTI’s work will increase the appropriate use of master protocol studies.
Role |
Name![]() |
Affiliation |
---|---|---|
Team Member | Abby Bronson | Edgewise Therapeutics |
Team Member | Alain Vuong | GlaxoSmithKline |
Team Member | Amy Burd | Leukemia & Lymphoma Society |
Team Member | Angie Botto-van Bemden | Arthritis Foundation |
Team Member | Antonia Valakas | EMD Serono |
Team Member | Barbara LeStage | Individual Patient/Caregiver |
Team Member | Christine Mayer-Nicolai | EMD Serono |
Team Lead | Daniel Millar | Janssen Pharmaceuticals |
Team Member | Debra Michaels | DIA |
Team Member | Dionne Price | Food and Drug Administration |
Team Member | Elena Kovalenko | Novartis |
Team Member | Emma Healy | Novartis |
Team Member | Gene Vinson | Syneos Health |
Team Member | Greg Licholai | Yale University |
Team Member | Hans-Juergen Fuelle | Novartis |
Team Member | Jane Perlmutter | Individual Patient/Caregiver |
Team Member | Karen Dimick | Genentech - a member of the Roche Group |
Team Member | Kert Viele | Berry Consultants |
Project Manager | Kim Fisher* | Clinical Trials Transformation Initiative |
Team Member | Kirsty Wydenback | Medicines and Healthcare Products Regulatory Agency (MHRA) |
Team Member | Louise Brown | University College London |
Team Lead | Marianne Chase | Harvard University |
Team Member | Michelle Detry | Berry Consultants |
Team Member | Nicholas Kenny | Syneos Health |
Team Lead | Nicholas Richardson | Food and Drug Administration |
Team Member | Pamela Tenaerts | Clinical Trials Transformation Initiative |
Team Member | Paul Bycott | Pfizer, Inc. |
Team Member | Paulina Selaru | Pfizer, Inc. |
Team Lead | Rajeshwari Sridhara | Food and Drug Administration |
Team Member | Ritesh Jain | EMD Serono |
Team Member | Roger Lewis | University of California, Los Angeles |
Team Member | Sabrina Paganoni | Harvard University |
Team Member | Sharon Love | University College London |
Team Lead | Shenghui Tang | Food and Drug Administration |
Team Member | Sumithra Mandrekar | Mayo Clinic |
Project Manager | Zachary Hallinan | Clinical Trials Transformation Initiative |