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Reinventing clinical trials

An Erratum to this article was published on 07 June 2012

This article has been updated

As R&D costs spiral for drug developers, disruptive approaches to clinical trial design and management are gaining traction. Get ready for electronic data capture, precompetitive data sharing, virtual trials and a variety of bold new paradigms.

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Figure 1: Reasons for clinical attrition.
Figure 2: FDA drug approvals per year.
Figure 3: Your clinical trial is texting you.
Figure 4: Density of clinical trials worldwide.

Change history

  • 11 May 2012

    In the version of the article originally published, the ExoInTouch product being used by Pfizer in its virtual trial for overactive bladder (OAB) is eDiary, not Recruit, which allows patients to report through mobile phone or internet portals. The Recruit technology is being used in other studies. The text references to Recruit have been replaced with an explanation of eDiary. Instead of “new technology to recruit patients faster and in a more standardized fashion, ”the text now reads, “new technology to allow home-based clinical trial data reporting.” Instead of “‘Recruit’ text messaging technology in a pilot study” for Detrol, the text now reads, “‘eDiary’ tool in a Phase 4 trial, called Research on Electronic Monitoring of OAB Treatment Experience.” Additional explanation has been added, including “Patients can respond to simple questionnaires (Fig. 3) via their mobile phones or home computers. If they delay in responding, a reminder can be sent.” And for space reasons, other text relating to Recruit, “The tool is integrated with Pfizer’s volunteer database and allows immediate text message-based communication and assessment of a subject’s suitability within 5-10 min” and “It can also be used to send protocol-specific messages to patients already enrolled in trials” was deleted. In addition, it should have been noted that Eric Westin, who was interviewed while senior director of Lilly Oncology, had left the company. The errors have been corrected in the HTML and PDF versions of the article.

References

  1. Hirschler, B. Drug R&D spending fell in 2010, and heading lower. Reuters <http://www.reuters.com/article/2011/06/26/pharmaceuticals-rd-idUSL6E7HO1BL20110626> (26 June, 2011)

  2. Arrowsmith, J. Phase II failures: 2008–2010. Nat. Rev. Drug Discov. 10, 328–329 (2011).

    Article  CAS  Google Scholar 

  3. Arrowsmith, J. Trial watch: phase III and submission failures: 2007–2010. Nat. Rev. Drug Discov. 10, 87 (2011).

    Article  CAS  Google Scholar 

  4. Wood, S. Drugs, money and glory: is cancer beating cardiovascular disease? Theheart.org <http://www.theheart.org/article/1261569.do> (11 August 2011).

  5. Hughes, B. 2009 FDA drug approvals. Nat. Rev. Drug Discov. 9, 89–92 (2010).

    Article  CAS  Google Scholar 

  6. Adams, C.P. & Brantner, V.V. Spending on new drug development. Health Econ. 19, 130–141 (2010).

    Article  Google Scholar 

  7. Getz, K.A. et al. Measuring the incidence, causes, and repercussions of protocol amendments. Drug Inf. J. 45, 265–275 (2011).

    Article  Google Scholar 

  8. Allison, M. The HER2 testing conundrum. Nat. Biotechnol. 28, 117–119 (2010).

    Article  CAS  Google Scholar 

  9. Silberman, S. Placebos are getting more effective. Drugmakers are desperate to know why. Wired, 24 August 2009. <http://www.wired.com/medtech/drugs/magazine/17-09/ff_placebo_effect?currentPage=all>

  10. Kaptchuk, T.J. et al. Placebos without deception: a randomized controlled trial in irritable bowel syndrome. PLoS One 5, e15591 (2010).

    Article  CAS  Google Scholar 

  11. Patel, S.M. et al. The placebo effect in irritable bowel syndrome trials: a meta-analysis. Neurogastroenterol. Motil. 17, 332–340 (2005).

    Article  CAS  Google Scholar 

  12. Anonymous. Clinical trial biz likely to be $546 mn by 2011: Assocham. The Economic Times <http://articles.economictimes.indiatimes.com/2008-07-15/news/28396102_1_assocham-president-sajjan-jindal-outsourced-industry-body> (15 July 2008).

  13. DHHS Office of the Inspector General. The Globalization of Clinical Trials: a Growing Challenge in Protecting Human Subjects (US Dept. Health and Human Services; September, 2001). <http://oig.hhs.gov/oei/reports/oei-01-00-00190.pdf>

  14. Pozzilli, P. et al. Metabolic and immune parameters at clinical onset of insulin-dependent diabetes: a population-based study. Metabolism 47, 1205–1210 (1998).

    Article  CAS  Google Scholar 

  15. Anonymous. Biomarkers on a roll. Nat. Biotechnol. 28, 431 (2010).

  16. Anonymous. Clinical Operations: Benchmarking per-patient costs, staffing and adaptive design. Cutting Edge <http://www.cuttingedgeinfo.com/research/clinical-development/trial-operations/> (15 July 2011).

  17. Allison, M. Biomarker-led adaptive trial blazes a trail in breast cancer. Nat. Biotechnol. 28, 383–384 (2010).

    Article  CAS  Google Scholar 

  18. Kim, E.S. et al. The BATTLE Trial: personalizing therapy for lung cancer. Cancer Discovery 1, 44–53 (2011).

    Article  CAS  Google Scholar 

  19. Wagner, J.A. et al. Utility of adiponectin as a biomarker predictive of glycemic efficacy is demonstrated by collaborative pooling of data from clinical trials conducted by multiple sponsors. Clin. Pharmacol. Ther. 86, 619–625 (2009).

    Article  CAS  Google Scholar 

  20. Benkler, Y. The Wealth of Networks (Yale University Press, 2006).

    Google Scholar 

  21. Lee, K. et al. Publication of clinical trials supporting successful new drug applications: a literature analysis. PLoS Med. 5, e191 (2008).

    Article  Google Scholar 

  22. Sutter, S. Disclosing drug discovery failures would aid regulatory science, FDA's Hamburg says. The Pink Sheet 73 <http://www.fdli.org/conf/annual/11/articles/thepinksheet.pdf> (11 April 2011).

  23. El Emam, K. et al. The use of electronic data capture tools in clinical trials: web-survey of 259 Canadian trials. J. Med. Internet Res. 11, e8 (2009).

    Article  Google Scholar 

  24. Kling, J. Nat. Biotechnol. 29, 197–200 (2011).

    Article  CAS  Google Scholar 

  25. Thiers, F.A., Sinskey, A.J. & Berndt, E.R. Nat. Rev. Drug Discov. 7, 13–14 (2008).

    Article  CAS  Google Scholar 

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Allison, M. Reinventing clinical trials. Nat Biotechnol 30, 41–49 (2012). https://doi.org/10.1038/nbt.2083

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