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Strategies to optimize expedited investigational new drug safety reports

Nature Reviews Clinical Oncology volume 13, pages 207–208 (2016)Cite this article

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Accurate and efficient expedited investigational new drug (IND) reporting is a crucial component of clinical research. The FDA, pharmaceutical companies, institutional review boards, and clinical investigators should develop dynamic standardized electronic forms with preferred, predetermined terms to harmonize their practices and to help optimize the quality of clinical research and maximize patient safety.

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References

  1. US Food and Drug Administration. Investigational new drug (IND) application. [online], (2014).

  2. Jarow, J. P., Casak, S., Chuk, M., Ehrlich, L. A. & Khozin, S. The majority of expedited investigational new drug safety reports are uninformative. Clin. Cancer Res. http://dx.doi.org/10.1158/1078-0432.CCR-15-2082, (2016).

  3. US Department of Health and Human Services. Guidance for industry and investigator safety reporting requirements for INDs and BA/BE studies. US Food and Drug Administration [online], (2012).

  4. [No authors listed.] Investigational new drug safety reporting: advancing CTTI recommendations. Clinical Trials Transformation Initiative [online], (2016).

  5. US Department of Health and Human Services. Safety assessment for IND safety reporting guidance for industry. US Food and Drug Administration [online], (2015).

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Authors and Affiliations

  1. Apostolia M. Tsimberidou is at the Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Unit 455, 1515 Holcombe Boulevard, Houston, Texas 77030, USA.,

    Apostolia M. Tsimberidou

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  1. Apostolia M. Tsimberidou
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Correspondence to Apostolia M. Tsimberidou.

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Competing interests

A.M.T. receives research funding from Baxalta, Bayer, EMD Serono, Foundation Medicine, and Onyx Pharmaceuticals.

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Tsimberidou, A. Strategies to optimize expedited investigational new drug safety reports. Nat Rev Clin Oncol 13, 207–208 (2016). https://doi.org/10.1038/nrclinonc.2016.42

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