The who, why, what, when, where, and how of clinical trial registries

Fertility and Sterility

Volumn 96, Issue 1, 2011, Pages 2-5

  Meldrum, David R ^a   Decherney, Alan H ^b  

^a Reproductive Partners Medical Group   (United States)

^b EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT   (United States)

Author keywords

Clinical trial registry; FDA clinical trial registry requirements

Indexed keywords

CLINICAL TRIAL (TOPIC); FOOD AND DRUG ADMINISTRATION; MEDICAL LITERATURE; MEDICAL RESEARCH; PEER REVIEW; PRIORITY JOURNAL; REGISTER; REVIEW;

EID: 79959865455     PISSN: 00150282     EISSN: 15565653     Source Type: Journal    
DOI: 10.1016/j.fertnstert.2011.05.028     Document Type: Article

References (12)

1. Ghersi, and T. Pang En route to international clinical trials transparency Lancet 372 2008 1531 1532
2. ICTRP. Search portal. Available at: http://www.who.int/ictrp/search/en/. Accessed April 23, 2011.
3. ICMJE. Uniform requirements for manuscripts. Available at: http://www.icmje.org/urm-main.html. Accessed April 23, 2011.
4. ICMJE. Definition of a clinical trial. Available at: http://www.icmje. org/faq-clinical.html. Accessed April 23, 2011.
5. Food and Drug Administration. Food and Drug Administration Amendments Act of 2007 (FDAAA). Available at: http://prsinfo.clinicaltrials.gov/fdaaa.html. Accessed April 23, 2011.
6. World Health Organization. Trial registration data set (TRDS). Available at: http://www.who.int/ictrp/network/trds/en/index.html. Accessed April 23, 2011.
7. L.P. Moja, I. Moschetti, M. Nurbhai, A. Compagnoni, A. Liberati, and J.M. Grimshaw Compliance of clinical trial registries with the World Health Organization minimum data set: a survey Trials 10 2009 56
8. Clinicaltrials.gov. "Basic results" data element definitions. Available at: http://prsinfo.clinicaltrials.gov/results-definitions.html. Accessed April 23, 2011.
9. D.A. Zarin, T. Tse, R.J. Williams, R.M. Califf, and C.I. Nicholas The clinicaltrials.gov results database - update and key issues N Engl J Med 364 2011 852 860
10. 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. Available at: http://www.icmje.org/update- may05.html. Accessed April 23, 2011.
11. Clinicaltrials.gov. Data element definitions. Available at: http://prsinfo.clinicaltrials.gov/definitions.html. Accessed April 23, 2011.
12. S. Mathieu, I. Boutron, D. Moher, D.G. Altman, and P. Ravaud Comparison of registered and published primary outcomes in randomized controlled trials JAMA 302 2009 977 984