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Suggested Citation:"References." Institute of Medicine. 2006. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11561.
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References

AMA (American Medical Association). 2004, June 15. AMA Recommends That DHHS Establish a Registry for All U.S. Clinical Trials. [Online]. Available: http://www.ama-assn.org/ama/pub/category/13934.html [accessed May 9, 2005].


Brownlee S. 2004. Doctors without borders: Why you can’t trust medical journals anymore. Washington Monthly. [Online]. Available: http://www.washingtonmonthly.com/features/2004/0404.brownlee.html [accessed May 9, 2005].


Chan A-W, Hrobjartsson A, Haahr MT, Gotzsche PC, Altman DG. 2004. Empirical evidence for selective reporting of outcomes in randomized trials. Comparison of protocols to published articles. Journal of the American Medical Association 291 (20):2457–2465.


De Angelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJ, Schroeder TV, Sox HC, Van Der Weyden MB. 2004. Clinical trial registration: A statement from the International Committee of Medical Journal Editors. Journal of the American Medical Association 292(11):1363–1364.

De Angelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJ, Schroeder TV, Sox HC, Van Der Weyden MB. 2005. Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors. Annals of Internal Medicine 143(2):146–148.

Drazen JM, Wood AJJ. 2005. Trial registration report card. New England Journal of Medicine 353:2809–2811.


European Federation of Pharmaceutical Industries and Associations. 2005. Joint Position on the Disclosure of Clinical Trial Information Via Clinical Trial Registries and Databases. [Online]. Available: http://www.efpia.org/4_pos/sci_regu/Clinicaltrials2005.pdf [accessed August 3, 2005].


Fair Access to Clinical Trials Act of 2005, H.R. 3196 and companion bill S.470. [Online]. Available: http://thomas.loc.gov/cgi-bin/query/z?c109:S.470 [accessed August 3, 2005].

Suggested Citation:"References." Institute of Medicine. 2006. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11561.
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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.


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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.

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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.

Suggested Citation:"References." Institute of Medicine. 2006. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11561.
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Page 47
Suggested Citation:"References." Institute of Medicine. 2006. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11561.
×
Page 48
Next: Appendix A Participants and Invited Experts - Between December 1, 2004 and June 27, 2005 »
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To improve public confidence in clinical research, a number of public and private groups have called for a publicly accessible, comprehensive, and transparent registry of relevant information on clinical trials for drugs and biologics. The public and various entities within the medical community (health care providers, researchers, medical journal editors, pharmaceutical companies, health insurers, and regulators) have different expectations and perceived needs regarding a public clinical trial registry.

The IOM Committee on Clinical Trial Registries hosted a workshop on June 27, 2005, to obtain much-needed input from members of the public, public advocate groups, and the broader community of journal editors, pharmaceutical and biotech leaders, NIH, and the FDA. Participants discussed the data elements that have been at the core of debate and commented on issues of compliance and implementation of a national clinical trial registry.

Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report inlcudes discussions at the workshop centered on the following five concepts, and are described within this report: 1) Purpose, 2) Which Trials to Include, 3) Delayed Disclosure Mechanism, 4) Reporting Results of Completed Trials, and 5) Compliance.

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