Open Clinical Trial Data for All? A View from Regulators

1. DoshiPJeffersonTDel MarC 2012 The imperative to share clinical study reports. PLoS Med 9

2. HrynaszkiewiczIAltmanDG 2009 Towards agreement on best practice for publishing raw clinical trial data. Trials 10 17 Available: http://www.trialsjournal.com/content/10/1/17. Accessed 9 March 2012

3. SelkerHPRuthazerRTerrinNGriffithJLConcannonT 2011 Random treatment assignment using mathematical equipoise for comparative effectiveness trials. Clin Transl Sci 4 1 10 16

4. KentDMHaywardRAGriffithJLVijanSBeshanskyJR 2002 An independently derived and validated predictive model for selecting patients with myocardial infarction who are likely to benefit from tissue plasminogen activator compared with streptokinase. Am J Med 113 2 104 111

5. NielsenM 2012 Reinventing discovery: the new era of networked science Princeton and Oxford Princeton University Press

6. PolandGAJacobsonRM 2011 The age-old struggle against the antivaccinationists. N Engl J Med 364 97 99

7. LofstedtRBouderFChakrabortyS 2012 Transparency and the FDA – a quantitative study. J Health Communications In press

8. MicheleTMPinheiroSIyasuS 2010 The safety of tiotropium — the FDA's conclusions. N Engl J Med 363 1097 1099

9. European Medicines Agency 2011 Questions and answers on the review of angiotensin II receptor antagonists and the risk of cancer. Available: http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2011/10/WC500116862.pdf. Accessed 9 March 2012

10. European Network of Centres for Pharmacoepidemiology and Pharmacovigilance 2011 The ENCePP Code of Conduct for Scientific Independence and Transparency in the Conduct of Pharmacoepidemiological and Pharmacovigilance Studies. Available: http://www.encepp.eu/code_of_conduct/documents/CodeofConduct_Rev2.pdf. Accessed 9 March 2012

11. YoungSSKarrA 2011 Deming, data and observational studies. Significance 8 3 116 120