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How Did These Data Get Here? Recommendations for the Analysis of Data From ClinicalTrials.gov

  • Clinical Trial: Commentary
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Abstract

A paper by Drs Okada and Sengoku that appears in this issue of TIRS shows how data from Clinicaltrials.gov can be used for research on the pharmaceutical industry. This commentary identifies several challenges associated with using these data for research and concludes with 3 recommendations from a statistical perspective.

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References

  1. Okada K, Sengoku S. Entry into new therapeutic areas: the effect of strategic alliance on clinical trials. TIRS 2018;

  2. Background. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/about-site/background. Accessed July 3, 2018.

  3. History, policies, and laws. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/about-site/history. Accessed July 3, 2018.

  4. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/home. Accessed July 3, 2018.

  5. Tse T, Fain KM, Zarin DA. How to avoid common problems when using ClinicalTrials.gov in research: 10 issues to consider. BMJ. 2018;361:k1452. doi: https://doi.org/10.1136/bmj.k1452.

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Authors and Affiliations

  1. Therapeutic Innovation and Regulatory Science Editorial Board Member, 4804 American Drive, Durham, NC, 27705, USA

    Todd A. Durham MS, PhD

Authors
  1. Todd A. Durham MS, PhD
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Correspondence to Todd A. Durham MS, PhD.

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Durham, T.A. How Did These Data Get Here? Recommendations for the Analysis of Data From ClinicalTrials.gov. Ther Innov Regul Sci 53, 639–640 (2019). https://doi.org/10.1177/2168479018811825

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  • DOI: https://doi.org/10.1177/2168479018811825

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