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The Clinical Trials Transformation Initiative: Methodology supporting the mission.

Publication ,  Journal Article
Corneli, A; Hallinan, Z; Hamre, G; Perry, B; Goldsack, JC; Calvert, SB; Forrest, A
Published in: Clin Trials
February 2018

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.

Duke Scholars

Published In

Clin Trials

DOI

EISSN

1740-7753

Publication Date

February 2018

Volume

15

Issue

1_suppl

Start / End Page

13 / 18

Location

England

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Statistics & Probability
  • Quality Improvement
  • Information Dissemination
  • Humans
  • Data Interpretation, Statistical
  • Data Accuracy
  • Clinical Trials as Topic
  • 5203 Clinical and health psychology
 

Citation

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Corneli, A., Hallinan, Z., Hamre, G., Perry, B., Goldsack, J. C., Calvert, S. B., & Forrest, A. (2018). The Clinical Trials Transformation Initiative: Methodology supporting the mission. Clin Trials, 15(1_suppl), 13–18. https://doi.org/10.1177/1740774518755054
Corneli, Amy, Zachary Hallinan, Gerrit Hamre, Brian Perry, Jennifer C. Goldsack, Sara B. Calvert, and Annemarie Forrest. “The Clinical Trials Transformation Initiative: Methodology supporting the mission.Clin Trials 15, no. 1_suppl (February 2018): 13–18. https://doi.org/10.1177/1740774518755054.
Corneli A, Hallinan Z, Hamre G, Perry B, Goldsack JC, Calvert SB, et al. The Clinical Trials Transformation Initiative: Methodology supporting the mission. Clin Trials. 2018 Feb;15(1_suppl):13–8.
Corneli, Amy, et al. “The Clinical Trials Transformation Initiative: Methodology supporting the mission.Clin Trials, vol. 15, no. 1_suppl, Feb. 2018, pp. 13–18. Pubmed, doi:10.1177/1740774518755054.
Corneli A, Hallinan Z, Hamre G, Perry B, Goldsack JC, Calvert SB, Forrest A. The Clinical Trials Transformation Initiative: Methodology supporting the mission. Clin Trials. 2018 Feb;15(1_suppl):13–18.
Journal cover image

Published In

Clin Trials

DOI

EISSN

1740-7753

Publication Date

February 2018

Volume

15

Issue

1_suppl

Start / End Page

13 / 18

Location

England

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Statistics & Probability
  • Quality Improvement
  • Information Dissemination
  • Humans
  • Data Interpretation, Statistical
  • Data Accuracy
  • Clinical Trials as Topic
  • 5203 Clinical and health psychology