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Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report (2006)
Board on Health Sciences Policy (HSP)

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Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Summary

The “file drawer phenomenon”: Suppressing clinical evidence. 2004. Canadian Medical Association Journal 170(4):437, 439.


ICH Harmonised Tripartite Guideline: Statistical Principles for Clinical Trials. 1998 (February 5). The ICH Steering Committee. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.


Kennedy D. 2004. Clinical trials and public trust. Science 306(5702):1649.


Public Welfare and Human Service Act. Title 45, Volume 1, Parts 1 to 199 NIH Grants Policy Statement. Terms and Conditions of NIH Grant Awards.


Santana S. 2004, August. Call for clinical trials registry gaining momentum. AAMC Reporter. [Online]. Available: http://www.aamc.org/newsroom/reporter/aug04/clinicaltrials.htm [accessed August 3, 2005].


U.S. DHHS (U.S. Department of Health and Human Services). 1998. Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products. [Online]. Available: http://www.fda.gov/cder/guidance/1397fnl.pdf [accessed May 9, 2005].

U.S. DHHS. 2002. Section 113. Information Program on Clinical Trials for Serious or Life-Threatening Diseases.


Whittington CJ, Kendall T, Fonagy P, Cottrell D, Cotgrove A, Boddington E. 2004. Selective serotonin reuptake inhibitors in childhood depression: Systematic review of published versus unpublished data. Lancet 363(9418):1341–1345.

WHO (World Health Organization). 2005. WHO International Clinical Trials Registry Platform. [Online]. Available: http://www.who.int/ictrp/en/ [accessed December 10, 2005].


Zarin DA, Tse T, Ide N. 2005. Trial registration at ClinicalTrials.gov between May and October 2005. New England Journal of Medicine 353:2779–2787.

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