Ethical considerations in studying drug safety--the Institute of Medicine report.
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[1] R. Misbin. Lessons From the Avandia Controversy , 2007, Diabetes Care.
[2] M. Hamburg,et al. Regulatory action on rosiglitazone by the U.S. Food and Drug Administration. , 2010, The New England journal of medicine.
[3] A. Lincoff,et al. Pioglitazone and risk of cardiovascular events in patients with type 2 diabetes mellitus: a meta-analysis of randomized trials. , 2007, JAMA.
[4] S. Nissen,et al. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. , 2007, The New England journal of medicine.
[5] D. Solomon. Selective cyclooxygenase 2 inhibitors and cardiovascular events. , 2005, Arthritis and rheumatism.
[6] S. Nissen. The rise and fall of rosiglitazone. , 2010, European heart journal.
[7] Jeffrey M Drazen,et al. Expression of concern: Bombardier et al., "Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis," N Engl J Med 2000;343:1520-8. , 2005, The New England journal of medicine.
[8] Erland Erdmann,et al. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial , 2005, The Lancet.
[9] K. Aaronson,et al. Risk of Worsening Renal Function With Nesiritide in Patients With Acutely Decompensated Heart Failure , 2005, Circulation.
[10] Tom Jefferson,et al. The Imperative to Share Clinical Study Reports: Recommendations from the Tamiflu Experience , 2012, PLoS medicine.
[11] E. Topol,et al. Effect of muraglitazar on death and major adverse cardiovascular events in patients with type 2 diabetes mellitus. , 2005, JAMA.
[12] K. Aaronson,et al. Short-term Risk of Death After Treatment With Nesiritide for Decompensated Heart Failure: A Pooled Analysis of Randomized Controlled Trials , 2005 .
[13] S. Yusuf,et al. Design, history and results of the Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) randomised controlled trial , 2011, Diabetologia.
[14] Aaron S Kesselheim,et al. Confidentiality laws and secrecy in medical research: improving public access to data on drug safety. , 2007, Health affairs.
[15] A. Park,et al. CENTER FOR DRUG EVALUATION AND RESEARCH , 2009 .
[16] M. A. Carter,et al. Bioethics and Post-approval Research in Translational Science , 2010, The American journal of bioethics : AJOB.
[17] S. Nissen,et al. Rosiglitazone revisited: an updated meta-analysis of risk for myocardial infarction and cardiovascular mortality. , 2010, Archives of internal medicine.
[18] C. Levine. Has AIDS Changed the Ethics of Human Subjects Research? , 1988, Law, medicine & health care : a publication of the American Society of Law & Medicine.
[19] Lisa Bero,et al. Reporting Bias in Drug Trials Submitted to the Food and Drug Administration: Review of Publication and Presentation , 2008, PLoS medicine.
[20] B. Psaty,et al. A lifecycle approach to the evaluation of FDA approval methods and regulatory actions: opportunities provided by a new IOM report. , 2012, JAMA.
[21] J. Kimmelman,et al. Rethinking Research Ethics: The Case of Postmarketing Trials , 2012, Science.