Using Master Protocol Studies to Drive Medical Product Development
Enthusiasm for master protocol studies is growing, but 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.
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.
|Project Manager||Kim Fisher||Clinical Trials Transformation Initiative|
|Team Member||Debra Michaels||DIA|
|Team Member||Antonia Valakas||EMD Serono|
|Team Member||Ritesh Jain||EMD Serono|
|Team Member||Dionne Price||Food and Drug Administration|
|Team Member||Rajeshwari Sridhara||Food and Drug Administration|
|Team Lead||Nicholas Richardson||Food and Drug Administration|
|Team Member||Karen Dimick||Genentech - a member of the Roche Group|
|Team Member||Alain Vuong||GlaxoSmithKline|
|Team Member||Sabrina Paganoni||Harvard University|
|Team Lead||Marianne Chase||Harvard University|
|Team Member||Jane Perlmutter||Individual Patient/Caregiver|
|Team Member||Barbara LeStage||Individual Patient/Caregiver|
|Team Lead||Daniel Millar||Janssen Pharmaceuticals|
|Team Member||Amy Burd||Leukemia & Lymphoma Society|
|Team Member||Sumithra Mandrekar||Mayo Clinic|
|Team Member||Kirsty Wydenback||Medicines and Healthcare Products Regulatory Agency (MHRA)|
|Team Member||Natasha Phrsai||Northwell Health|
|Team Member||Hans-Juergen Fuelle||Novartis|
|Team Member||Emma Healy||Novartis|
|Team Lead||Abby Bronson||Parent Muscular Dystrophy Project|
|Team Member||Paulina Selaru||Pfizer, Inc.|
|Team Member||Paul Bycott||Pfizer, Inc.|
|Team Member||Gene Vinson||Syneos Health|
|Team Member||Nicholas Kenny||Syneos Health|
|Team Member||Roger Lewis||UCLA/Berry Consulting|
|Team Member||Sharon Love||University College London|
|Team Member||Louise Brown||University College London|
|Team Member||Greg Licholai||Yale University|