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The Clinical Trials Transformation Initiative: innovation through collaboration

Nature Reviews Drug Discovery volume 13, pages 797–798 (2014)Cite this article

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he Clinical Trials Transformation Initiative (CTTI) identifies and promotes practices to increase the quality and efficiency of clinical trials through projects that generate empirical data on how trials are currently conducted, leading to recommendations for improvement.

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References

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Author information

Authors and Affiliations

  1. Clinical Trials Transformation Initiative, Duke Translational Medicine Institute, 300 West Morgan Street, Suite 800, Durham, 27701, North Carolina, USA

    Pamela Tenaerts & Leanne Madre

  2. Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, 20993, Maryland, USA

    Patrick Archdeacon

  3. Duke Translational Medicine Institute, Durham, 27710, North Carolina, USA

    Robert M. Califf

Authors
  1. Pamela Tenaerts
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  2. Leanne Madre
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  3. Patrick Archdeacon
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  4. Robert M. Califf
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Corresponding author

Correspondence to Pamela Tenaerts.

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Competing interests

R.M.C has received research grants from Amylin, Bristol-Myers Squibb, Eli Lilly, Janssen Research and Development, Merck and Novartis, and consultancy fees from Medscape, Amgen and Novartis. He also has ownership interest in N30 Pharma and Portola. P.T., L.M. and P.A. declare no competing interests.

Supplementary information

Supplementary information S1 (figure)

Clinical Trial Transformation Initiative member organizations (PDF 167 kb)

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FURTHER INFORMATION

Clinical Trials Transformation Initiative. CTTI Quality by Design Workshops Project — critical to quality (CTQ) factors. Version 06JAN14

European Medicines Agency. Reflection paper on risk based quality management in clinical trials

Mini-Sentinel and Clinical Trials Transformation Initiative. Developing approaches to conducting randomized trials using the Mini-Sentinel distributed database

US Food and Drug Administration. Guidance for industry: Oversight of clinical investigations — a risk-based approach to monitoring (draft)

US Food and Drug Administration. Guidance for industry — using a centralized IRB review process in multicenter clinical trials

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Tenaerts, P., Madre, L., Archdeacon, P. et al. The Clinical Trials Transformation Initiative: innovation through collaboration. Nat Rev Drug Discov 13, 797–798 (2014). https://doi.org/10.1038/nrd4442

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