Lack of transparency in clinical trials: a call for action
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The purpose of pharmacological and non-pharmacological medical interventions are maintenance of good health, delay pathology and rehabilitate patients with disability. Because any intervention have the risk of adverse effects, physicians have to weigh benefits against harms before deciding the best treatment for the patient condition, a practice of rational prescription supported by high-quality evidence from randomized clinical trials and meta-analysis. Non-rational prescription of therapeutic interventions could result in severe adverse reactions. These unwanted effects could lead to increased patient visits to emergency rooms, prolonged hospitalizations, disability, loss of productivity days and patient death. Adverse reactions increase health care system costs and often lead to legal actions against physicians, hospitals, and pharmaceutical companies.
- Clinical trials
- ethics
- human research
- medical interventions
- rational prescription
De Angelis C, Drazen J, M Frizelle FA, Haug C, Hoey J, Horton R, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. N Engl J Med 2004;351:1250-1. DOI: https://doi.org/10.1056/NEJMe048225
Reveiz L, Villanueva E, Iko C, Simera I. Compliance with clinical trial registration and reporting guidelines by Latin American and Caribbean journals. Cadernos de Saúde Pública 2013;29:1095-100. DOI: https://doi.org/10.1590/S0102-311X2013000600006
Turner L, Shamseer L, Altman DG, Weeks L, Peters J, Kober T, Dias S, Schulz KF, Plint AC, Moher D. Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals. Cochrane Database of Systematic Reviews 2012, Issue 11. Art. No.: MR000030. DOI: https://doi.org/10.1002/14651858.MR000030.pub2
Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. The Lancet, 357(9263), 1191-1194.4. DOI: https://doi.org/10.1016/S0140-6736(00)04337-3
Latin Americans ‘guinea pigs’ for foreign clinical trials. URL:
http://www.ipsnews.net/2011/01/latin-americans-guinea-pigs-for-foreign-clinical-trials/ (accessed December 9 2013).
Jones CW, Handler L, Crowell KE, Keil LG, Weaver MA, Platts-Mills TF. Non-publication of large randomized clinical trials: cross sectional analysis. BMJ 2013; 347: f6104. DOI: https://doi.org/10.1136/bmj.f6104
Goldacre B. Are clinical trial data shared sufficiently today? No. BMJ 2013;347:f1880. DOI: https://doi.org/10.1136/bmj.f1880
Cohen D. US trade agreement threatens to increase drug prices and withhold safety data
BMJ 2013;347:f6908.
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