The randomized registry trial--the next disruptive technology in clinical research?

نویسندگان

  • Michael S Lauer
  • Ralph B D'Agostino
چکیده

1. Zarin DA. Participant-level data and the new frontier in trial transparency. N Engl J Med 2013;369:468-9. 2. European Medicines Agency. Publication and access to clinical-trial data: draft policy 0070. June 24, 2013 (http://www.ema.europa .eu/docs/en_GB/document_library/Other/ 2013/06/WC500144730.pdf). 3. Pharmaceutical Research and Manufacturers of America, European Federation of Pharmaceutical Industries and Associations. Principles for responsible clinical trial data sharing (http://phrma.org/sites/default/files/ pdf/PhRMAPrinciplesForResponsibleClinical TrialDataSharing.pdf). 4. Rabinowitz J, Werbeloff N, Stauffer V, Mandel F, Kapur S. More efficient drug discovery trials in schizophrenia: insights from 29 placebo-controlled randomised controlled trials (RCTs) from the NEWMEDS repository. Presented at the 24th Congress of the European College of Neuropsychopharmacology, Paris, September 3–7, 2011 (http://conference services.elsevier.nl/11ecnp/index.cfm?fuse action=CIS2002&hoofdnav=Search&content =zk.results_all&topicselected=*&searchtext =rabinowitz&what=FREE%20TEXT&selection =ALL&abstrnbr=S.11.03). 5. Catalyzing the transformation of healthcare innovation: a working paper from the MIT Center for Biomedical Innovation. Cambridge: Massachusetts Institute of Technology, January 2010 (http://cbi.mit.edu/ wp-content/uploads/2011/04/MIT-NewDigs -White-Paper-20100118.pdf).

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عنوان ژورنال:
  • The New England journal of medicine

دوره 369 17  شماره 

صفحات  -

تاریخ انتشار 2013