Clinical Trials Registries: A Reform That is Past Due

De Angelis C. Drazen J. M. Frizelle F. A. , “Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors,” N. Engl. J. Med. 254 (2004): 1250–1.

In a RCT, subjects are randomly allocated to either the treatment group, or the control group; the control group receives a placebo in lieu of the actual intervention. RCTs may be open (i.e., both the researcher and patient know which group the patient is in), single-blind (the researcher knows but the patient does not), or double-blind (neither party is aware).

Lillenfeld A. M. , “Ceteris Parabus: The Evolution of the Clinical Trial,” Bulletin of the History of Medicine 56 (1982): 1–18.

Dickersin K. Rennie D. , “Registering Clinical Trials,” JAMA 290 (2003): 516–523.

Grady D. Herrington D. , V. Bittner, et al., for the HERS Research Group, “Cardiovascular Disease Outcomes during 6.8 years of Hormone Therapy,” JAMA 288 (2002): 49–57; Hulley S. Furberg C. Barrett-Connor E. “Non-cardiovascular Disease Outcomes during 6.8 years of Hormone Therapy: Health and Estrogen/progestin Replacement Study Follow-up (HERS II),” JAMA 288 (2002): 58–66; Writing Group for the Women's Health Initiative Investigators, “Risks and Benefits of Estrogen plus Progestin in Healthy Postmenopausal Women: Principal Results from the Women's Health Initiative Randomized Controlled Trial,” JAMA 288 (2002): 321–333.

Shojania K. G. Duncan B. W. McDonald K. M. Wachter R. M. , “Safe but Sound: Patient Safety meets Evidence-based Medicine,” JAMA 288 (2002): 508–13.

Scherer R. W. Langenberg P. , full publication of results initially presented in abstracts [ Cochrane Methodology Review ] (Oxford, England: Cochrane Library, Update Software, 2003): Issue 1. See also Dickersin Rennie , supra note 6.

Hartling L. Craig W. R. Russell K. Stevens K. Klassen T. P. , “Factors Influencing the Publication of Randomized Controlled Trials in Child Health Research,” Archives of Pediatric and Adolescent Medicine 158 (2004): 983–7.

Chalmers I. , “Underreporting Research is Scientific Misconduct,” JAMA 263 (1990): 1405–1408.

See Dickersin Rennie , supra note 6.

Callaham M. L. Wears R. L. Weber E. J. Barton C. Young G. , “Positive-outcome Bias and other Limitations in the Outcome of Research Abstracts Submitted to a Scientific Meeting,” JAMA 280 (1998): 254–257; Eloubeidi M. A. Wade S. B. Provenzale D. , “Factors Associated with Acceptance and Full Publication of GI Endoscopic Research Originally Published in Abstract Form,” Gastrointestinal Endoscopy 53 (2001): 275–282.

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Dickersin K. Chan S. Chalmers T. C. Sacks H. S. Smith H. J. R. , “Publication Bias and Clinical Trials,” Controlled Clinical Trials 8 (1987): 343–353.

Systematic reviews and meta-analyses compile the results of all clinical trials on a particular drug or other intervention, and reevaluate its effectiveness using a greater amount of data.

Spitzer v. GlaxoSmithKline PLC, N.Y. Sup. Ct., No. 04/401707.

Martinez B. , “Glaxo Settles New York Suit over Unpublished Clinical Data,” The Wall Street Journal, August 27, 2004, at B3.

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See Huston Moher , supra note 23.

Ibid.

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Section 113, Information Program on Clinical Trials for Serious or Life-Threatening Diseases, Food and Drug Administration Modernization Act of 1997, Public Law 105–115.

National Library of Medicine, “Fact Sheet: ClinicalTrials.gov,” at <http://www.nlm.nih.gov/pubs/factsheets/clintrial.html> (last visited August 23, 2005).

“About the metaRegister of Controlled Trials and rationale,” at <http://www.controlled-trials.com/mrct/mrct_about.asp> (last visited August 23, 2005).

“ISRCTN FAQ”, at <http://www.controlled-trials.com/isrctn/isrctn_faqs.asp> (last visited August 23, 2005).

PhRMA, “Update principles for conduct of clinical trials and communication of clinical trial results. June 30, 2004,” at <www.phrma.org/mediaroom/press/releases/30.06.2004.427.cfm> (last visited August 23, 2005).

<www.lillytrials.com> (last visited August 23, 2005).

Phase I studies are designed to establish the effects of a new drug in humans. These studies are usually conducted on small populations of healthy humans to specifically determine a drug's toxicity, absorption, distribution and metabolism. After the successful completion of phase I trials, a drug is then tested for safety and efficacy in a slightly larger population of individuals who are afflicted with the disease or condition for which the drug was developed. This is known as a Phase II study. The third and last pre-approval round of testing of a drug is conducted on large populations of afflicted patients. Phase III studies usually test the new drug in comparison with the standard therapy currently being used for the disease in question. The results of these trials usually provide the information that is included in the package insert and labeling. After a drug has been approved by the FDA, Phase IV studies are conducted to compare the drug to a competitor, explore additional patient populations, or to further study any adverse events. (From <http://www.centerwatch.com/patient/glossary.html> [last visited August 23, 2005]).

Lilly Eli , “Initiated Trials” at <http://www.liHytrials.com/initiated/initiated.html> (last visited August 23, 2005).

Meier B. , “Drug Industry Plans Release of More Data About Studies,” New York Times, January 7, 2005.

At <http://clinicaltrials.gov/ct/screen/BrowseAny?path=%2Fbrowse%2Fby-sponsor%2FINDUSTRY&recruiting=false> (last visited August 23, 2005).

See Dickersin Rennie , supra note 6.

Couzin J. , “Legislators Propose a Registry to Track Clinical Trials from Start to Finish,” Science 305 (2004): 1695.

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World Health Organization, “WHO leads drive for international coordination of clinical research,” April 2 2004. At <www.who.int/mediacentre/news/releases/2004/pr23/en/> (last visited August 23, 2005).

Abbasi K. , “Compulsory Registration of Clinical Trials,” British Medical Journal 329 (2004): 637–638.

“ISRCTN application form,” at <http://controlled-trials.com/isrctn/submission/> (last visited August 23, 2005).

Cohen P. , “Medical Journals to Require Clinical Trial Registration,” New Scientist , September 9, 2004 available at <www.newsrientist.com/news/printjsp?id=ns99996378> (last visited August 23, 2005).

Cochrane Collaboration, “What is the Cochrane Collaboration?” Available at <http://www.cochrane.org/docs/descrip.htm> (last visited August 23, 2005).

See for example: “EUROPA, Combating AIDS, Malaria and Tuberculosis: Commissioner Busquin in Dakar for Clinical Trials Partnership Launch,” at <http://europa.eu.int/comm/research/press/2004/pr2302en.cfm> (last visited August 23, 2005); PR Newswire, “Aeras Receives CDC Funding to Develop TB Vaccine Trial Sites in India,” at <http://sev.prnewswire.com/health-care-hospitals/20040917/DCF01917092004–1.html> (last visited August 23, 2005); NIH News Release, “New Awards, Expanded Focus for Pediatric AIDS Clinical Trials Group,” at <http://www.nih.gov/news/pr/mar2002/niaid07.htm> (last visited August 23, 2005).

See Abbasi , supra note 43 and Cohen , supra note 45.

Thompson D. F. , “Understanding Financial Conflicts of Interest,” N. Engl. J. Med. 329 (1993): 573–6.

Rennie D. , “Trial Registration: A Great Idea Switches from Ignored to Irresistible,” JAMA 292 (2004): 1359–1362.

See Rennie , supra note 50.