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A cancer trial scandal and its regulatory backlash

Regulatory fallout from a scandal surrounding the fabrication of data used to support a molecular test in a Duke University cancer trial is exacting an unjustifiable toll not only on health economics but also on patient lives.

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References

  1. Hart, P.K. Houston docs found leak in Holy Grail of cancer treatment. Houston Chronicle http://www.chron.com/news/kilday-hart/article/Hart-Houston-docs-found-leak-in-Holy-Grail-of-3341794.php (18 February 2012).

    Google Scholar 

  2. Institute of Medicine. Evolution of translational omics: lessons learned and the path forward. http://www.iom.edu/Reports/2012/Evolution-of-Translational-Omics/Report-Brief.aspx (23 March 2012).

  3. US Food and Drug Administration. Device advice: investigational device exemption (IDE). http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance /HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/default.htm (updated 23 December 2013).

  4. Kim, E.S. et al. Cancer Discov. 1, 44–53 (2011).

    Article  CAS  Google Scholar 

  5. Beckloff Associates, Inc. The regulatory paradox of laboratory developed tests. http://cardinalhealth.com/beckloff/documents/pdf/TheRegulatoryParadoxofLaboratoryDevelopedTests.pdf (accessed 12 December 2013).

  6. Non-Small Cell Lung Cancer Collaborative Group. Br. Med. J. 311, 899–909 (1995).

  7. National Cancer Institute. Non-small cell lung cancer treatment. http://www.cancer.gov/cancertopics/pdq/treatment/non-small-cell-lung/healthprofessional/page11#Section_48414 (updated 30 May 2013).

  8. Laack, E. et al. J. Clin. Oncol. 22, 2348–2356 (2004).

    Article  CAS  Google Scholar 

  9. Monnerat, C. & Le Chevalier, T. Ann. Oncol. 17 (suppl. 5), v86–v90 (2006).

    Article  Google Scholar 

  10. Spigel, D.R. et al. J. Thorac. Oncol. 5, 841–845 (2010).

    Article  Google Scholar 

  11. D'Addario, G. et al. J. Clin. Oncol. 23, 2926–2936 (2005).

    Article  CAS  Google Scholar 

  12. Rajeswaran, A., Trojan, A., Burnand, B. & Giannelli, M. Lung Cancer 59, 1–11 (2008).

    Article  Google Scholar 

  13. Pujol, J.L., Barlesi, F. & Daurès, J.P. Lung Cancer 51, 335–345 (2006).

    Article  Google Scholar 

  14. Verma, S. et al. N. Engl. J. Med. 367, 1783–1791 (2012).

    Article  CAS  Google Scholar 

  15. US Food & Drug Administration. FDA approves new treatment for late-stage breast cancer http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm340704.htm (22 February 2013).

  16. Burris, H.A. III et al. J. Clin. Oncol. 29, 398–405 (2011).

    Article  CAS  Google Scholar 

  17. F. Hoffman-La Roche Ltd. Roche provides update on FDA application for T-DM1. http://www.roche.com/media/media_releases/med-cor-2010-08-27.htm (27 August 2010).

  18. Stewart, D.J., Whitney, S.N. & Kurzrock, R. J. Clin. Oncol. 28, 2925–2935 (2010).

    Article  Google Scholar 

  19. Westin, J.R. & Kurzrock, R. Mol. Cancer Ther. 11, 2549–2555 (2012).

    Article  CAS  Google Scholar 

  20. Kantarjian, H. et al. N. Engl. J. Med. 362, 2260–2270 (2010).

    Article  CAS  Google Scholar 

  21. Behazin, N.S. Gastrointestinal stromal tumors. Medscape http://emedicine.medscape.com/article/179669-overview (updated 11 March 2013).

  22. Stewart, D.J. & Kurzrock, R. J. Clin. Oncol. 27, 328–333 (2009).

    Article  Google Scholar 

  23. Schulman, K.A. J. Investig. Med. 58, 31–32 (2010).

    Google Scholar 

  24. Most clinical trials done abroad. Wall Street Journal http://online.wsj.com/news/articles/SB123499424805316443 (18 February 2009).

  25. Janku, F. et al. Clin. Cancer Res. 18, 6356–6363 (2012).

    Article  CAS  Google Scholar 

  26. Tsimberidou, A.M. et al. Clin. Cancer Res. 18, 6373–6383 (2012).

    Article  CAS  Google Scholar 

  27. Stewart, D.J. & Kurzrock, R. BMC Cancer 13, 193 (2013).

    Article  Google Scholar 

Download references

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Correspondence to Razelle Kurzrock.

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Competing interests

R.K. received a Merck Honorarium ($3,500). D.J.S. has been a consultant for various firms, including the Frankel Group, Aligh2Action, Amgen, Roche Canada, Boehringer Ingelheim Canada and Guidepoint Global; has been a speaker at events sponsored by Pfizer Canada, AstraZeneca Taiwan and Ventana; and has been supported by grants to his institution from AstraZeneca, Roche Canada and Pfizer. None of foregoing for D.J.S. is related to the present work.

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Kurzrock, R., Kantarjian, H. & Stewart, D. A cancer trial scandal and its regulatory backlash. Nat Biotechnol 32, 27–31 (2014). https://doi.org/10.1038/nbt.2792

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