CAPÍTULO 4. MALOS ENSAYOS CLÍNICOS

[1] «Fraud Case Rocks Anesthesiology Community», Anesthesiology News - [Internet] [citado el 12 febrero de 2012]. Disponible en ​http://www.anesthesiologynews.com/ViewArticle.aspx?d_id=3&a_id=12634. <<

[2] La historia aparece bien explicada en Wells, F., Fraud and Misconduct in Biomedical Research, RSM Books, 2008, capítulo 5, 43 ed. Les recomiendo encarecidamente este libro si desean empezar a leer sobre cómo detectar y abordar el fraude. Les advierto que es un libro académico y terriblemente caro. <<

[3] Rothwell, P. M., «External validity of randomised controlled trials: “To whom the results of this trial apply?”», The Lancet, vol. 365, n.° 9453, 1 de enero de 2005, págs. sz-93. <<

[4] Pratt, C. M., Moye, L. A., «The Cardiac Arrhythmia Suppression Trial: Casting Suppression in a Different Light», Circulation, vol. 91, n.° 1, 1995, págs. 245-247. <<

[5] Travers, J. y otros, «External validity of randomised controlled trials in asthma: to whom do the results of the trials apply?», Thorax, vol. 62, n.° 3, 2007, págs. 219-223. <<

[6] Zimmerman, M., Chelminski, I., Posternak, M. A., «Exclusion criteria used in antidepressant efficacy trials: consistency across studies and representativeness of samples included», The Journal of Nervous and Mental Disease, vol. 192, n.° 2, 2004, págs. 87-94. <<

[7] Keitner, G-I., Posternak, M. A., Ryan, C. E., «How many subjects with major depressive disorder meet eligibility requirements of an antidepressant efficacy trial?», The Journal of Clinical Psychiatry, vol. 64, n.° 9, 2003, págs. 1091-1093. <<

[8] Jarvinen, T. L. N., Sievanen, H., Kannus, P., Jokihaara, J., Khan, K. M., «The true cost of pharmacological disease prevention», British Medical Journal, vol. 342, 19 de abril de 2011, d2175. <<

[9] Van Staa, T-P, Leufkens, H. G., Zhang, B., Smeeth, L. A., «Comparison of Cost Effectiveness Using Data from Randomized Trials or Actual Clinical Practice: Selective Cox-2 Inhibitors as an Example», PLoS Medicine, vol. 6, n.° 12, 8 de diciembre de 2009, el000194. <<

[10] Safer, D. J., «Design and reporting modifications in industry-sponsored comparative psychopharmacology trials», Journal of Nervous and Mental Disease, vol. 190, n.° 9, septiembre de 2009, págs. 583-592. <<

[11] Califf, R. M., DeMets, D. L., «Principles From Clinical Trials Relevant to Clinical Practice: Part I», Circulation, vol. 106, n.° 8, 20 de agosto de 2002, págs. 1015-1021. <<

[12] Mueller, P. S., Montori, V. M., Bassler, D., Koenig, B. A., Guyatt, G. H., «Ethical Issues in Stopping Randomized Trials Early Because of Apparent Benefit», Annals of Internal Medicine, vol. 146, n.° 12, 19 de junio de 2007, págs. 878-881. <<

[13] Bassler, D., Briel, M., Montori, V. M., Lane, M., Glasziou, P., Zhou, Q. y otros, «Stopping Randomized Trials Early for Benefit and Estimation of Treatment Effects: Systematic Review and Meta-regression Analysis», Journal of the American Medical Association, vol. 303, n.° 12, 24 de marzo de 2010, págs. 1180-1187. <<

[14] Montori, V. M., Devereaux, P. J., Adhikari, N Burns, K. E. A., Eggert, C. H., Briel, M. y otros, «Randomized Trials Stopped Early for Benefit: A Systematic Review», Journal of the American Medical Association, vol. 294, n.° 17, 2 de noviembre de 2005, págs. 2203-2209. <<

[15] Trotta, F., Apolone, G., Garattini, S., Tafuri, G., «Stopping a trial early in oncology: for patients or for industry?», Annals of Oncology [Internet], enero 2008 [citado el 14 febrero de 2012]. Disponible en ​http://annonc.oxfordjournals.org/content/early/2008/04/09/annonc.mdn042.full. <<

[16] Lurie, P., Wolfe, S. M., «Misleading data analyses in salmeterol (SMART) study», The Lancet, vol. 366, n.° 9493, octubre de 2005, págs. 1261-1262. <<

[17] Richard, K. A., «Misleading data analyses in salmeterol (SMART) study – GlaxoSmithKline’s reply», The Lancet, vol. 366, n.° 9493, octubre de 2005, págs. 1262. <<

[18] Garcialopez, F., Dealvano, F., «INSIGHT and NORDIL», The Lancet, vol. 356, n.° 9245, diciembre de 2000, pág. 1926. <<

[19] Safer, D. J., «Design and reporting modifications in industry-sponsored comparative psychopharmacology trials», Journal of Nervous and Mental Disease, vol. 190, n.° 9, septiembre de 2002, págs. 583-592. <<

[20] Gilbody, S., Wahlbeck, K., Adams, C., «Randomized controlled trials in schizophrenia: a critical perspective on the literature», Acta Psychiatrica Scandinavica, vol. 105, 2002, págs. 243-251. <<

[21] Montori, V. M., Jaeschke, R., Schünemann, H. J., Bhandari, M., Brozek, J. L., Devereaux, P. J. y otros, «User’s guide to detecting misleading claims in clinical research reports», British Medical Journal, vol. 329, n.° 7474, 6 de noviembre de 2004, págs. 1093-1096. <<

[22] Shaughnessy, A. F., Slawson, D. C., «What happened to the valid POEMs? A survey of review articles on the treatment of type-2 diabetes», British Medical Journal, vol. 327, n.° 7409, agosto de 2003, pág. 266. <<

[23] Melander, H., Ahlqvist-Rastad, J., Meijer, G., Beermann, B., «Evidence b(i) ased medicine-selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications», British Medical Journal, vol. 326, 2003,págs. 1171-1173. <<

[24] Vedula, S., Swaroop, Lisa Bero, Roberta W. Scherer y Kay Dickersin, «Out-come reporting in industry-sponsored trials of gabapentin for off-label use», New England Journal of Medicine vol. 361, n.° 20, 12 de noviembre de 2009, págs. 1963-1971. <<

[25] Chan, A-W, Hróbjartsson, A., Haahr, M. T., Gøtzsche, P. C., Altman, D. G., «Empirical evidence for selective reporting of outcomes in randomized trials: comparison protocols to published articles», Journal of the American Medical Association, vol. 291, 2004, págs. 2457-2465. <<

[26] Jon, N. Jureidimi, Leemon, B. McHenry, Peter R. Mansfield, «Clinical trials and drug promotion: Selective reporting of study 329», International Journal of Risk & Safety in Medicine, vol. 20,2008, págs. 73-81 73 DOI 10.3233/JRS-2008-0426. <<

[27] Lee, K. L. y otros, «Clinical judgment and statistics. Lessons from a simulated randomized trial in coronary artery disease», Circulation vol. 61, n.° 3, marzo de 1980, págs. 508-515. <<

[28] Sobre análisis de subgrupo, recomiendo el excelente artículo de revisión de Peter Rothwell: Rothwell, P. M., «Subgroup analysis in randomised controlled trials: importance, indications, and interpretation», The Lancet, vol. 365, n.° 9454, 2005, págs. 176-186. Disponible gratuito en ​http://apps.who.int/rhl/Lancet_365-9454.pdf. <<

[29] EuropenaCarotidSurgeryTrialists’CollaborativeGroup, «Randomised trial of endarterectomy for recently symptomatic carotid stenosis: final results of the MRC European Carotid Surgery Trial (ECST)», The Lancet, vol. 351, 1998, págs. 1379-1387. <<

[30] The Canadian Cooperative Study Group, «A randomised trial of aspirin and sulfinpyrazone in threatened stroke», New England Journal of Medicine, vol. 299, 1978, págs. 53-59. <<

[31] Ioannidis, J. P. A., Karassa, F. B., «The need to consider the wider agenda in systematic reviews and meta-analyses: breadth, timing, and depth of the evidence», British Medical Journal, vol. 341, septiembre, 2010, c4875. <<

[32] Hill, K. P., Ross, J. S., Egilman, D. S., Krumholz, H. M., «The ADVANTAGE Seeding Trial: A Review of Internal Documents», Annals of Internal Medicine, vol. 149, 11° 4, 2008, págs. 251-258. <<

[33] Sox, H. C., Rennie, D. Seeding, «Trials: Just Say “No”», Annals of Internal Medicine, vol. 149, n.° 4, 2008, págs, 279-280. <<

[34] Krumholz, S. D., Egilman, D. S., Ross, J. S., «Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS) Trial: A Narrative Account of Gabapentin Seeding Trial», Archives of Internal Medicine, vol. 171, n.° 12, 27 de junio de 2011, págs. 1100-1107. <<

[35] Recomiendo este libro como introducción a «decisión compartida» (yo contribuí a un capítulo): Gigerenzer, G., Muir, G., Better Doctors, Better Patients, Better Decisions: Envisioning Health Care 2020, MIT Press, 2011. <<

[36] Malenka, D. J., Baron, J. A., Johansen, S., Wahrenberger, J. W., Ross, J. M., «The framing effect of relative and absolute risk», Journal of General Internal Medicine, vol. 8, n.° 10, octubre de 1993, págs. 543-548. <<

[37] Bucher, H. C., Weinbacher, M., Gyr, K., «Influence of method of reporting study results on decision of physicians to prescribe drugs to lower cholesterol concentration», British Medical Journal, vol. 309, n.° 6957, 24 de septiembre de 1994, págs. 761-764. <<

[38] Fahey, T., Griffiths, S., Peters, T. J., «Evidence based purchasing: understanding results of clinical trials and systematic reviews», British Medical Journal, vol. 311, n.° 7012, 21 de octubre de 1995, págs. 1056-1059. <<

[39] «New wonder heart pill that may save millions», Express.co.uk [Internet] [citado el 12 de febrero de 2012]. Disponible en ​http://www.express.co.uk/posts/view/70343. <<

[40] «Drug could save thousands from heart attacks» - Science - The Guardian [Internet] [citado el 12 de febrero de 2012]. Disponible en ​http://www.guardian.co.uk/science/2008/nov/10/drugsmedical-research. <<

[41] Boutron, I., Dutton, S., Ravaud, P., Altman, D. G., «Reporting and Interpretation of Randomized Controlled Trials With Statistically Nonsignificant Results for Primary Outcomes», Journal of the American Medical Association, vol. 303, n.° 20, 26 de mayo de 2010, págs. 2058-2064. <<

[42] Alasbali, T. y otros, «Discrepancy between results and abstract conclusions in industry vs. nonindustry-funded studies comparing topical prostaglandins», American Journal of Ophtalmology, vol. 147, n.° 1, 2009, págs. 33-38.e2. <<

[43] Jørgensen, A. W., I-Iilden, J., Gøtzsche, P. C., «Cochrane reviews compared with industry supported meta-analyses and other meta-analyses of the same drugs: systematic review», British Medical Journal, vol. 333, n.° 7572, 14 de octubre de 2006, pág. 782. <<