Box

References

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The 20 data items required for trial registration (see also http://www.who.int/ictrp/data_set/en/index1.html)

Unique trial number

Trial registration date

Secondary trial identifiers

Funding source

Primary sponsor

Secondary sponsor

Responsible contact person

Research contact person

Title of the study

Official scientific title of the study

Research ethics review

Condition

Interventions

Key inclusion and exclusion criteria

Study type

Anticipated trial start date

Target sample size

Recruitment status

Primary outcome

Key secondary outcomes

References

w1 Chalmers T. Randomize the first patient! N Engl J Med 1977;296:107.

w2 Horton R, Smith R. Time to register clinical trials. BMJ 1999; 19:865-6.

w3 Antex G, Chalmers I. Under-reporting of clinical trials is unethical. Lancet 2003;361:978-9.

w4 Sykes R. Being a modern pharmaceutical company. BMJ 1998;317:1172-80.

w5 Food and Drug Administration Modernization Act of 1997. www.fda.gov/Cder/guidance/105-115.htm (accessed 8 May 2006).

w6 Dickersin K, Rennie D. Registering clinical trials. JAMA 2003;290:516-23.

w7 Dyer O. Disease awareness campaigns turn healthy people into patients. BMJ 2006;332:871.

w8 Tanne JH. NEJM stands by its criticism of Vioxx study. BMJ 2006;332:505.

w9 Collier J. Let them eat Prozac. BMJ��2004;328:411.

w10 World Health Organization. International Clinical Trials Registry Platform. 2006. www.who.int/ictrp/en (accessed 8 May 2006).

w11 De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Is this clinical trial fully registered?: a Statement from the International Committee of Medical Journal Editors. May 2005. www.icmje.org/clin_trialup.htm (accessed 8 May 2006).

w12 Goodyear M. Learning from the TGN1412 trial. BMJ 2006;332:677-8.

w13 Chan AW, Upshur R, Singh JA, Ghersi D, Chapuis F, Altman D. Waiving confidentiality for the greater good. BMJ 2006;332:1086-9.

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