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
Okada K, Sengoku S. Entry into new therapeutic areas: the effect of strategic alliance on clinical trials. TIRS 2018;
Background. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/about-site/background. Accessed July 3, 2018.
History, policies, and laws. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/about-site/history. Accessed July 3, 2018.
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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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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