The Clinical Trials Transformation Initiative: Methodology supporting the mission
| Autor: | Amy Corneli, Sara B. Calvert, Jennifer C. Goldsack, Zachary P Hallinan, Gerrit Hamre, Brian Perry, Annemarie Forrest |
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| Rok vydání: | 2018 |
| Předmět: |
Pharmacology
Clinical Trials as Topic Process management Information Dissemination United States Food and Drug Administration General Medicine 01 natural sciences Quality Improvement Transformation (music) United States Data Accuracy Food and drug administration Clinical trial 010104 statistics & probability 03 medical and health sciences 0302 clinical medicine General partnership Data Interpretation Statistical Humans 030212 general & internal medicine Multi stakeholder Business 0101 mathematics |
| Zdroj: | Clinical trials (London, England). 15(1_suppl) |
| ISSN: | 1740-7753 |
| Popis: | The mission of the Clinical Trials Transformation Initiative, a public–private partnership co-founded by the U.S. Food and Drug Administration and Duke University, is to develop and drive adoption of practices that will increase the quality and efficiency of clinical trials. The Clinical Trials Transformation Initiative works collaboratively with key stakeholders, implements “fit-for-purpose” evidence-gathering projects, and develops actionable recommendations and tools to address the challenges faced by the clinical trials enterprise. In pursuit of its mission, The Clinical Trials Transformation Initiative follows an innovative and collaborative, five-step methodology: (1) state the problem and identify impediments to research, (2) gather evidence to identify gaps and barriers, (3) explore results by analyzing and interpreting findings, (4) finalize solutions by developing recommendations and tools, and (5) drive adoption through disseminating and implementing recommendations and tools. This article describes each step of the Clinical Trials Transformation Initiative's methodology, with a specific focus on describing the evidence-gathering activities. |
| Databáze: | OpenAIRE |
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