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.
This is a preview of subscription content, access via your institution
Relevant articles
Open Access articles citing this article.
-
Molecular basis of mood and cognitive adverse events elucidated via a combination of pharmacovigilance data mining and functional enrichment analysis
Archives of Toxicology Open Access 05 June 2020
-
Sample size implications of mortality definitions in sepsis: a retrospective cohort study
Trials Open Access 27 March 2018
-
Integrating technology into complex intervention trial processes: a case study
Trials Open Access 17 November 2016
Access options
Subscribe to this journal
Receive 12 print issues and online access
$209.00 per year
only $17.42 per issue
Rent or buy this article
Prices vary by article type
from$1.95
to$39.95
Prices may be subject to local taxes which are calculated during checkout
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
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)
Arrowsmith, J. Phase II failures: 2008–2010. Nat. Rev. Drug Discov. 10, 328–329 (2011).
Arrowsmith, J. Trial watch: phase III and submission failures: 2007–2010. Nat. Rev. Drug Discov. 10, 87 (2011).
Wood, S. Drugs, money and glory: is cancer beating cardiovascular disease? Theheart.org <http://www.theheart.org/article/1261569.do> (11 August 2011).
Hughes, B. 2009 FDA drug approvals. Nat. Rev. Drug Discov. 9, 89–92 (2010).
Adams, C.P. & Brantner, V.V. Spending on new drug development. Health Econ. 19, 130–141 (2010).
Getz, K.A. et al. Measuring the incidence, causes, and repercussions of protocol amendments. Drug Inf. J. 45, 265–275 (2011).
Allison, M. The HER2 testing conundrum. Nat. Biotechnol. 28, 117–119 (2010).
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>
Kaptchuk, T.J. et al. Placebos without deception: a randomized controlled trial in irritable bowel syndrome. PLoS One 5, e15591 (2010).
Patel, S.M. et al. The placebo effect in irritable bowel syndrome trials: a meta-analysis. Neurogastroenterol. Motil. 17, 332–340 (2005).
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).
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>
Pozzilli, P. et al. Metabolic and immune parameters at clinical onset of insulin-dependent diabetes: a population-based study. Metabolism 47, 1205–1210 (1998).
Anonymous. Biomarkers on a roll. Nat. Biotechnol. 28, 431 (2010).
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).
Allison, M. Biomarker-led adaptive trial blazes a trail in breast cancer. Nat. Biotechnol. 28, 383–384 (2010).
Kim, E.S. et al. The BATTLE Trial: personalizing therapy for lung cancer. Cancer Discovery 1, 44–53 (2011).
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).
Benkler, Y. The Wealth of Networks (Yale University Press, 2006).
Lee, K. et al. Publication of clinical trials supporting successful new drug applications: a literature analysis. PLoS Med. 5, e191 (2008).
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).
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).
Kling, J. Nat. Biotechnol. 29, 197–200 (2011).
Thiers, F.A., Sinskey, A.J. & Berndt, E.R. Nat. Rev. Drug Discov. 7, 13–14 (2008).
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Allison, M. Reinventing clinical trials. Nat Biotechnol 30, 41–49 (2012). https://doi.org/10.1038/nbt.2083
Published:
Issue Date:
DOI: https://doi.org/10.1038/nbt.2083
This article is cited by
-
TRIPODD: a Novel Fluorescence Imaging Platform for In Situ Quantification of Drug Distribution and Therapeutic Response
Molecular Imaging and Biology (2021)
-
Molecular basis of mood and cognitive adverse events elucidated via a combination of pharmacovigilance data mining and functional enrichment analysis
Archives of Toxicology (2020)
-
Human pharmacology of positive GABA-A subtype-selective receptor modulators for the treatment of anxiety
Acta Pharmacologica Sinica (2019)
-
Sample size implications of mortality definitions in sepsis: a retrospective cohort study
Trials (2018)
-
Construction of 3D multicellular microfluidic chip for an in vitro skin model
Biomedical Microdevices (2017)