US drug discovery consortia

The Clinical Trials Transformation Initiative: innovation through collaboration

Journal name:
Nature Reviews Drug Discovery
Volume:
13,
Pages:
797–798
Year published:
DOI:
doi:10.1038/nrd4442
Published online

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.

References

  1. Landray, M. J. et al. Clinical trials: rethinking how we ensure quality. Drug Inf. J. 46, 657660 (2012).
  2. Archdeacon, P. et al. Optimizing expedited safety reporting for drugs and biologics subject to an investigational new drug application. Ther. Innov. Regul. Sci. 48, 200207 (2013).
  3. US FDA. Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Fed. Regist. 75, 5993559963 (2010).
  4. Menikoff, J. The paradoxical problem with multiple-IRB review. N. Engl. J. Med. 363, 15911593 (2010).
  5. Flynn, K. E. et al. Using central IRBs for multicenter clinical trials in the United States. PLoS ONE 8, e54999 (2013).

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Author information

Affiliations

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

    • Pamela Tenaerts &
    • Leanne Madre
  2. Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, USA.

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

    • Robert M. Califf

Competing interests statement

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.

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Supplementary information

PDF files

  1. Supplementary information S1 (figure) (167 KB)

    Clinical Trial Transformation Initiative member organizations

Additional data