Mobilizing the clinical trial ecosystem to drive adoption of master protocols.
Clin Trials
; 19(6): 690-696, 2022 Dec.
Article
in English
| MEDLINE | ID: covidwho-2138991
ABSTRACT
Master protocol studies typically use an overarching protocol to answer several questions by guiding a variety of sub-studies. These sub-studies can incorporate multiple diseases, therapies, or both. Although this innovative approach offers many benefits, including the ability to deliver clinical research that is more patient-centric and efficient, several common barriers curtail widespread adoption. The Clinical Trials Transformation Initiative (CTTI) convened industry representatives, regulatory agencies, patient groups, and academic institutions to identify emerging best practices and develop resources designed to help sponsors and other stakeholders overcome these challenges. We first identify some broad changes needed in the clinical trials ecosystem to facilitate mainstream adoption of master protocol studies, and we subsequently summarize CTTI's resources designed to support this effort.
Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Ecosystem
Type of study:
Experimental Studies
/
Prognostic study
/
Randomized controlled trials
Limits:
Humans
Language:
English
Journal:
Clin Trials
Journal subject:
Medicine
/
Therapeutics
Year:
2022
Document Type:
Article
Affiliation country:
17407745221110199
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