Salud y Fármacos is an international non-profit organization that promotes access and the appropriate use of pharmaceuticals among the Spanish-speaking population.



Sesgo de notificación en la investigación médica – Una revisión narrativa
Natalie McGauran, Beate Wieseler, Julia Kreis, Yvonne-Beatrice Schüler, Heike Kölsch y Thomas Kaiser
Traducido por Salud y Farmacos de: Reporting Bias in Medical Research – A Narrative Review,Trials 2010; 11:37


  1. Green S, Higgins S, editors: Glossary. Cochrane Handbook for Systematic Reviews of Interventions 4.2.5. []
  2. Sterne J, Egger M, Moher D: Addressing reporting biases. In Cochrane handbook for systematic reviews of interventions. Edited by: Higgins JPT, Green S. Chichester: Wiley; 2008:297-334. OpenURL
  3. Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan AW, Cronin E, Decullier E, Easterbrook PJ, Von Elm E, Gamble C, Ghersi D, Ioannidis JP, Simes J, Williamson PR: Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS ONE 2008, 3:e3081. OpenURL
  4. Blumle A, Antes G, Schumacher M, Just H, Von Elm E: Clinical research projects at a German medical faculty: follow-up from ethical approval to publication and citation by others. J Med Ethics 2008, 34:e20. OpenURL
  5. Von Elm E, Rollin A, Blumle A, Huwiler K, Witschi M, Egger M: Publication and non-publication of clinical trials: longitudinal study of applications submitted to a research ethics committee. Swiss Med Wkly 2008, 138:197-203. OpenURL
  6. Dickersin K, Min YI, Meinert CL: Factors influencing publication of research results: follow-up of applications submitted to two institutional review boards. JAMA 1992, 267:374-378. OpenURL
  7. Easterbrook PJ, Berlin JA, Gopalan R, Matthews DR: Publication bias in clinical research. Lancet 1991, 337:867-872. OpenURL
  8. Stern JM, Simes RJ: Publication bias: evidence of delayed publication in a cohort study of clinical research projects. BMJ 1997, 315:640-645. OpenURL
  9. Pich J, Carne X, Arnaiz JA, Gomez B, Trilla A, Rodes J: Role of a research ethics committee in follow-up and publication of results. Lancet 2003, 361:1015-1016. OpenURL
  10. Decullier E, Lheritier V, Chapuis F: Fate of biomedical research protocols and publication bias in France: retrospective cohort study. BMJ 2005, 331:19-24. OpenURL
  11. Lee K, Bacchetti P, Sim I: Publication of clinical trials supporting successful new drug applications: a literature analysis. PLoS Med 2008, 5:e191. OpenURL
  12. Hemminki E: Study of information submitted by drug companies to licensing authorities. Br Med J 1980, 280:833-836.
  13. MacLean CH, Morton SC, Ofman JJ, Roth EA, Shekelle PG: How useful are unpublished data from the Food and Drug Administration in meta-analysis? J Clin Epidemiol 2003, 56:44-51. OpenURL
  14. 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. BMJ 2003, 326:1171-1173. OpenURL
  15. Benjamin DK Jr, Smith PB, Murphy MD, Roberts R, Mathis L, Avant D, Califf RM, Li JS: Peer-reviewed publication of clinical trials completed for pediatric exclusivity. JAMA 2006, 296:1266-1273. OpenURL
  16. Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R: Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med 2008, 358:252-260. OpenURL
  17. Bardy AH: Bias in reporting clinical trials. Br J Clin Pharmacol 1998, 46:147-150. OpenURL
  18. Ioannidis JP: Effect of the statistical significance of results on the time to completion and publication of randomized efficacy trials. JAMA 1998, 279:281-286. OpenURL
  19. Hopewell S, Clarke M, Stewart L, Tierney J: Time to publication for results of clinical trials. Cochrane Database Syst Rev 2007, (2):MR000011. OpenURL
  20. Institute for Quality and Efficiency in Health Care: General methods: version 3.0. []
  21. National Institute for Health and Clinical Excellence: Guide to the methods of technology appraisal. London. 2008. OpenURL
  22. Scherer RW, Langenberg P, Von Elm E: Full publication of results initially presented in abstracts. Cochrane Database Syst Rev 2007, (2):MR000005.OpenURL
  23. Altman D: Outcome reporting bias in meta-analyses. []
  24. Chan AW, Hrobjartsson A, Haahr MT, Gotzsche PC, Altman DG: Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA 2004, 291:2457-2465.
  25. Chan AW, Altman DG: Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors. BMJ 2005, 330:753. OpenURL
  26. Rising K, Bacchetti P, Bero L: Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation. PLoS Med 2008, 5:e217. OpenURL
  27. Chan AW, Krleza-Jeric K, Schmid I, Altman DG: Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research. CMAJ 2004, 171:735-740. OpenURL
  28. Al-Marzouki S, Roberts I, Evans S, Marshall T: Selective reporting in clinical trials: analysis of trial protocols accepted by The Lancet. Lancet 2008, 372:201. OpenURL
  29. Ioannidis JP, Lau J: Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas. JAMA 2001, 285:437-443. OpenURL
  30. Hazell L, Shakir SA: Under-reporting of adverse drug reactions: a systematic review. Drug Saf 2006, 29:385-396.
  31. Bonhoeffer J, Zumbrunn B, Heininger U: Reporting of vaccine safety data in publications: systematic review. Pharmacoepidemiol Drug Saf 2005, 14:101-106. OpenURL
  32. Loke YK, Derry S: Reporting of adverse drug reactions in randomised controlled trials: a systematic survey. BMC Clin Pharmacol 2001, 1:3. OpenURL
  33. Ioannidis JP, Cappelleri JC, Sacks HS, Lau J: The relationship between study design, results, and reporting of randomized clinical trials of HIV infection. Control Clin Trials 1997, 18:431-444. OpenURL
  34. Dickersin K: Reporting and other biases in studies of Neurontin for migraine, psychiatric/bipolar disorders, nociceptive pain, and neuropathic pain. []
  35. Nassir Ghaemi S, Shirzadi AA, Filkowski M: Publication bias and the pharmaceutical industry: the case of lamotrigine in bipolar disorder. Medscape J Med 2008, 10:211. OpenURL
  36. Sterling T: Publication decisions and their possible effects on inferences drawn from tests of significances. J Am Stat Assoc 1959, 54:30-34.
  37. Hopewell S, Loudon K, Clarke MJ, Oxman AD, Dickersin K: Publication bias in clinical trials due to statistical significance or direction of trial results. Cochrane Database Syst Rev 2009, (1):MR000006. OpenURL
  38. Song F, Eastwood AJ, Gilbody S, Duley L, Sutton AJ: Publication and related biases. Health Technol Assess 2000, 4:1-115. OpenURL
  39. Dickersin K, Chan S, Chalmers TC, Sacks HS, Smith H Jr: Publication bias and clinical trials. Control Clin Trials 1987, 8:343-353. OpenURL
  40. Krzyzanowska MK, Pintilie M, Tannock IF: Factors associated with failure to publish large randomized trials presented at an oncology meeting. JAMA 2003, 290:495-501. OpenURL
  41. Timmer A, Hilsden RJ, Cole J, Hailey D, Sutherland LR: Publication bias in gastroenterological research: a retrospective cohort study based on abstracts submitted to a scientific meeting. BMC Med Res Methodol 2002, 2:7. OpenURL
  42. Tramer MR, Reynolds DJ, Moore RA, McQuay HJ: Impact of covert duplicate publication on meta-analysis: a case study. BMJ 1997, 315:635-640. OpenURL
  43. Gotzsche PC: Reference bias in reports of drug trials. Br Med J (Clin Res Ed) 1987, 295:654-656. OpenURL
  44. Kjaergard LL, Gluud C: Citation bias of hepato-biliary randomized clinical trials. J Clin Epidemiol 2002, 55:407-410. OpenURL
  45. Ravnskov U: Quotation bias in reviews of the diet-heart idea. J Clin Epidemiol 1995, 48:713-719. OpenURL
  46. Egger M, Zellweger-Zahner T, Schneider M, Junker C, Lengeler C, Antes G: Language bias in randomised controlled trials published in English and German. Lancet 1997, 350:326-329. OpenURL
  47. Lee KP, Boyd EA, Holroyd-Leduc JM, Bacchetti P, Bero LA: Predictors of publication: characteristics of submitted manuscripts associated with acceptance at major biomedical journals. Med J Aust 2006, 184:621-626. OpenURL
  48. Callaham ML, Wears RL, Weber EJ, Barton C, Young G: Positive-outcome bias and other limitations in the outcome of research abstracts submitted to a scientific meeting. JAMA 1998, 280:254-257. OpenURL
  49. Lexchin J, Bero LA, Djulbegovic B, Clark O: Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 2003, 326:1167-1170. OpenURL
  50. Ramsey S, Scoggins J: Commentary: practicing on the tip of an information iceberg? Evidence of underpublication of registered clinical trials in oncology. Oncologist 2008, 13:925-929. OpenURL
  51. Olson CM, Rennie D, Cook D, Dickersin K, Flanagin A, Hogan JW, Zhu Q, Reiling J, Pace B: Publication bias in editorial decision making. JAMA 2002, 287:2825-2828. OpenURL
  52. Okike K, Kocher MS, Mehlman CT, Heckman JD, Bhandari M: Publication bias in orthopaedic research: an analysis of scientific factors associated with publication in the Journal of Bone and Joint Surgery (American Volume). J Bone Joint Surg Am 2008, 90:595-601. OpenURL
  53. Dickersin K, Min YI: NIH clinical trials and publication bias. Online J Curr Clin Trials 1993. OpenURLDoc No 50:[4967 words; 4953 paragraphs].
  54. Hartmann M, Knoth H, Schulz D, Knoth S: Industry-sponsored economic studies in oncology vs studies sponsored by nonprofit organisations. Br J Cancer 2003, 89:1405-1408. OpenURL
  55. Bekelman JE, Li Y, Gross CP: Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA 2003, 289:454-465. OpenURL
  56. Sismondo S: Pharmaceutical company funding and its consequences: a qualitative systematic review. Contemp Clin Trials 2008, 29:109-113. OpenURL
  57. Jorgensen AW, Hilden J, Gotzsche PC: Cochrane reviews compared with industry supported meta-analyses and other meta-analyses of the same drugs: systematic review. BMJ 2006, 333:782. OpenURL
  58. Liss H: Publication bias in the pulmonary/allergy literature: effect of pharmaceutical company sponsorship. Isr Med Assoc J 2006, 8:451-454. OpenURL
  59. Ridker PM, Torres J: Reported outcomes in major cardiovascular clinical trials funded by for-profit and not-for-profit organizations: 2000-2005. JAMA 2006, 295:2270-2274. OpenURL
  60. Als-Nielsen B, Chen W, Gluud C, Kjaergard LL: Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events? JAMA 2003, 290:921-928. OpenURL
  61. Perlis CS, Harwood M, Perlis RH: Extent and impact of industry sponsorship conflicts of interest in dermatology research. J Am Acad Dermatol 2005, 52:967-971. OpenURL
  62. Bhandari M, Busse JW, Jackowski D, Montori VM, Schünemann H, Sprague S, Mears D, Schemitsch EH, Heels-Ansdell D, Devereaux PJ: Association between industry funding and statistically significant pro-industry findings in medical and surgical randomized trials. CMAJ 2004, 170:477-480.
  63. Kjaergard LL, Als-Nielsen B: Association between competing interests and authors’ conclusions: epidemiological study of randomised clinical trials published in the BMJ. BMJ 2002, 325:249. OpenURL
  64. Lauritsen K, Havelund T, Laursen LS, Rask-Madsen J: Withholding unfavourable results in drug company sponsored clinical trials. Lancet 1987, 1:1091. OpenURL
  65. Wise J: Research suppressed for seven years by drug company. BMJ 1997, 314:1145. OpenURL
  66. Williams HC: Evening primrose oil for atopic dermatitis. BMJ 2003, 327:1358-1359. OpenURL
  67. Henry DA, Kerridge IH, Hill SR, McNeill PM, Doran E, Newby DA, Henderson KM, Maguire J, Stokes BJ, Macdonald GJ, Day RO: Medical specialists and pharmaceutical industry-sponsored research: a survey of the Australian experience. Med J Aust 2005, 182:557-560. OpenURL
  68. Gotzsche PC, Hrobjartsson A, Johansen HK, Haahr MT, Altman DG, Chan AW: Constraints on publication rights in industry-initiated clinical trials. JAMA 2006, 295:1645-1646. OpenURL
  69. Stafford N: German agency refuses to rule on drug’s benefits until Pfizer discloses all trial results. BMJ 2009, 338:b2521. OpenURL
  70. Whittington CJ, Kendall T, Fonagy P, Cottrell D, Cotgrove A, Boddington E: Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data. Lancet 2004, 363:1341-1345. OpenURL
  71. Cowley AJ, Skene A, Stainer K, Hampton JR: The effect of lorcainide on arrhythmias and survival in patients with acute myocardial infarction: an example of publication bias. Int J Cardiol 1993, 40:161-166. OpenURL
  72. Moore TJ: Deadly medicine: why tens of thousands of heart patients died in America’s worst drug disaster. New York: Simon & Schuster; 1995. OpenURL
  73. Mathews A, Martinez B: E-mails suggest Merck knew Vioxx’s dangers at early stage. Wall Street Journal 2004, A1. OpenURL
  74. Psaty BM, Kronmal RA: Reporting mortality findings in trials of rofecoxib for Alzheimer disease or cognitive impairment: a case study based on documents from rofecoxib litigation. JAMA 2008, 299:1813-1817. OpenURL
  75. Rosenberg SA: Secrecy in medical research. N Engl J Med 1996, 334:392-394. OpenURL
  76. Baker CB, Johnsrud MT, Crismon ML, Rosenheck RA, Woods SW: Quantitative analysis of sponsorship bias in economic studies of antidepressants. Br J Psychiatry 2003, 183:498-506. OpenURL
  77. Moncrieff J: Clozapine v. conventional antipsychotic drugs for treatment-resistant schizophrenia: a re-examination. Br J Psychiatry 2003, 183:161-166. OpenURL
  78. Montgomery JH, Byerly M, Carmody T, Li B, Miller DR, Varghese F, Holland R: An analysis of the effect of funding source in randomized clinical trials of second generation antipsychotics for the treatment of schizophrenia. Control Clin Trials 2004, 25:598-612. OpenURL
  79. Procyshyn RM, Chau A, Fortin P, Jenkins W: Prevalence and outcomes of pharmaceutical industry-sponsored clinical trials involving clozapine, risperidone, or olanzapine. Can J Psychiatry 2004, 49:601-606. OpenURL
  80. Perlis RH, Perlis CS, Wu Y, Hwang C, Joseph M, Nierenberg AA: Industry sponsorship and financial conflict of interest in the reporting of clinical trials in psychiatry. Am J Psychiatry 2005, 162:1957-1960. OpenURL
  81. Heres S, Davis J, Maino K, Jetzinger E, Kissling W, Leucht S: Why olanzapine beats risperidone, risperidone beats quetiapine, and quetiapine beats olanzapine: an exploratory analysis of head-to-head comparison studies of second-generation antipsychotics. Am J Psychiatry 2006, 163:185-194. OpenURL
  82. Kelly RE Jr, Cohen LJ, Semple RJ, Bialer P, Lau A, Bodenheimer A, Neustadter E: Relationship between drug company funding and outcomes of clinical psychiatric research. Psychol Med 2006, 36:1647-1656. OpenURL
  83. Kirsch I, Deacon BJ, Huedo-Medina TB, Scoboria A, Moore TJ, Johnson BT: Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration. PLoS Med 2008, 5:e45. OpenURL
  84. Office of the Attorney General: Major pharmaceutical firm concealed drug information. []
  85. Office of the Attorney General: Settlement sets new standard for release of drug information. []
  86. Gibson L: GlaxoSmithKline to publish clinical trials after US lawsuit. BMJ 2004 , 328:1513. OpenURL
  87. Institute for Quality and Efficiency in Health Care: Bupropion, mirtazapine and reboxetine in the treatment of depression: executive summary of preliminary report; commission no A05-20C. [http:/ / download/ A05-20C_Executive_summary_Bupropion _mirtazapine_and_reboxetine_in_the_ treatment_of_depression.pdf]
  88. Institute for Quality and Efficiency in Health Care: Antidepressants: benefit of reboxetine not proven. [http:/ / antidepressants-benefit-of-reboxeti ne-not-proven.981.en.html]
  89. Abramson J: Expert report. []
  90. Vedula SS, Bero L, Scherer RW, Dickersin K: Outcome reporting in industry-sponsored trials of gabapentin for off-label use. N Engl J Med 2009 , 361:1963-1971. OpenURL
  91. Vedantam S: A silenced drug study creates an uproar. Washington Post 2009 , A01. OpenURL
  92. Turner EH: A taxpayer-funded clinical trials registry and results database. PLoS Med 2004, 1:e60. OpenURL
  93. Singh D: Merck withdraws arthritis drug worldwide. BMJ 2004, 329:816.
  94. Lenzer J, Brownlee S: An untold story? BMJ 2008, 336:532-534. OpenURL
  95. Waknine Y: Bextra withdrawn from market. [] Medscape Today [Online] 2005. OpenURL
  96. Hiatt WR: Observational studies of drug safety–aprotinin and the absence of transparency. N Engl J Med 2006, 355:2171-2173. OpenURL
  97. Tuffs A: Bayer withdraws heart surgery drug. BMJ 2007, 335:1015. OpenURL
  98. Furberg CD: Effect of antiarrhythmic drugs on mortality after myocardial infarction. Am J Cardiol 1983, 52:32C-36C. OpenURL
  99. Antes G: Tödliche Medizin. Unpublizierte Studien – harmlos? [Fatal medicine. Unpublished studies – harmless?]. MMW Fortschr Med 2006, 148:8.
  100. Hine LK, Laird N, Hewitt P, Chalmers TC: Meta-analytic evidence against prophylactic use of lidocaine in acute myocardial infarction. Arch Intern Med 1989, 149:2694-2698.
  101. MacMahon S, Collins R, Peto R, Koster RW, Yusuf S: Effects of prophylactic lidocaine in suspected acute myocardial infarction: an overview of results from the randomized, controlled trials. JAMA 1988, 260:1910-1916. OpenURL
  102. Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. The Cardiac Arrhythmia Suppression Trial (CAST) Investigators. N Engl J Med 1989, 321:406-412. OpenURL
  103. Barbehenn E, Lurie P, Wolfe SM: Alosetron for irritable bowel syndrome. Lancet 2000, 356:2009-2010. OpenURL
  104. Moynihan R: Alosetron: a case study in regulatory capture, or a victory for patients’ rights? BMJ 2002, 325:592-595. OpenURL
  105. Bombardier C, Laine L, Reicin A, Shapiro D, Burgos-Vargas R, Davis B, Day R, Ferraz MB, Hawkey CJ, Hochberg MC, Kvien TK, Schnitzer TJ, VIGOR Study Group: Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med 2000, 343:1520-1528. OpenURL
  106. Mukherjee D, Nissen SE, Topol EJ: Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA 2001, 286:954-959. OpenURL
  107. McCormack JP, Rangno R: Digging for data from the COX-2 trials. CMAJ 2002, 166:1649-1650. OpenURL
  108. Silverstein FE, Faich G, Goldstein JL, Simon LS, Pincus T, Whelton A, Makuch R, Eisen G, Agrawal NM, Stenson WF, Burr AM: Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: a randomized controlled trial. JAMA 2000, 284:1247-1255.
  109. Lurie P, Zieve A: Sometimes the silence can be like the thunder: access to pharmaceutical data at the FDA. Law Contemp Probl 2008, 69:85-97. OpenURL
  110. Nissen S, Califf R: A conversation about rosiglitazone. [] Medscape Diabetes & Endocrinology [Online] 2007. OpenURL
  111. Nissen SE, Wolski K: Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007, 356:2457-2471. OpenURL
  112. Mitka M: Controversies surround heart drug study: questions about Vytorin and trial sponsors’ conduct. JAMA 2008, 299:885-887. OpenURL
  113. Kastelein JJ, Akdim F, Stroes ES, Zwinderman AH, Bots ML, Stalenhoef AF, Visseren FL, Sijbrands EJ, Trip MD, Stein EA, Duivenvoorden R, Veltri EP, Marais AD, de Groot E, ENHANCE Investigators: Simvastatin with or without ezetimibe in familial hypercholesterolemia. N Engl J Med 2008, 358:1431-1443. OpenURL
  114. Psaty BM, Furberg CD, Ray WA, Weiss NS: Potential for conflict of interest in the evaluation of suspected adverse drug reactions: use of cerivastatin and risk of rhabdomyolysis. JAMA 2004, 292:2622-2631. OpenURL
  115. Tuffs A: Bayer faces potential fine over cholesterol lowering drug. BMJ 2001, 323:415. OpenURL
  116. King RT Jr: Bitter pill: how a drug firm paid for university study, then undermined it. Wall Street Journal 1996, 1:A13. OpenURL
  117. Dong BJ, Hauck WW, Gambertoglio JG, Gee L, White JR, Bubp JL, Greenspan FS: Bioequivalence of generic and brand-name levothyroxine products in the treatment of hypothyroidism. JAMA 1997, 277:1205-1213. OpenURL
  118. Kenemans P, Bundred NJ, Foidart JM, Kubista E, von Schoultz B, Sismondi P, Vassilopoulou-Sellin R, Yip CH, Egberts J, Mol-Arts M, Mulder R, van Os S, Beckmann MW, LIBERATE Study Group: Safety and efficacy of tibolone in breast-cancer patients with vasomotor symptoms: a double-blind, randomised, non-inferiority trial. Lancet Oncol 2009, 10:135-146. OpenURL
  119. Lippegaus O, Prokscha S, Thimme C: Verharmloste Gefahren. Krebs durch Hormonbehandlung [Trivialised dangers. Cancer caused by hormone therapy]. [,1872,7593675,00.html]
  120. Doroshow JH: Commentary: publishing cancer clinical trial results: a scientific and ethical imperative. Oncologist 2008, 13:930-932. OpenURL
  121. Simes RJ: Publication bias: the case for an international registry of clinical trials. J Clin Oncol 1986, 4:1529-1541. OpenURL
  122. Takeda A, Loveman E, Harris P, Hartwell D, Welch K: Time to full publication of studies of anti-cancer medicines for breast cancer and the potential for publication bias: a short systematic review. Health Technol Assess 2008, 12:iii-x. OpenURL1-46
  123. Peppercorn J, Blood E, Winer E, Partridge A: Association between pharmaceutical involvement and outcomes in breast cancer clinical trials. Cancer 2007, 109:1239-1246. OpenURL
  124. Kyzas PA, Loizou KT, Ioannidis JP: Selective reporting biases in cancer prognostic factor studies. J Natl Cancer Inst 2005, 97:1043-1055. OpenURL
  125. Begg CB, Pocock SJ, Freedman L, Zelen M: State of the art in comparative cancer clinical trials. Cancer 1987, 60:2811-2815. OpenURL
  126. Kyzas PA, Denaxa-Kyza D, Ioannidis JP: Almost all articles on cancer prognostic markers report statistically significant results. Eur J Cancer 2007, 43:2559-2579. OpenURL
  127. Manheimer E, Anderson D: Survey of public information about ongoing clinical trials funded by industry: evaluation of completeness and accessibility. BMJ 2002, 325:528-531. OpenURL
  128. Rennie D: Thyroid storm. JAMA 1997, 277:1238-1243. OpenURL
  129. Godlee F, Clarke M: Why don’t we have all the evidence on oseltamivir? BMJ 2009, 339:b5351. OpenURL
  130. Jefferson TO, Demicheli V, Di Pietrantonj C, Jones M, Rivetti D: Neuraminidase inhibitors for preventing and treating influenza in healthy adults. Cochrane Database Syst Rev 2006, 3:CD001265. OpenURL
  131. Kaiser L, Wat C, Mills T, Mahoney P, Ward P, Hayden F: Impact of oseltamivir treatment on influenza-related lower respiratory tract complications and hospitalizations. Arch Intern Med 2003, 163:1667-1672. OpenURL
  132. Jefferson T, Jones M, Doshi P, Del Mar C: Neuraminidase inhibitors for preventing and treating influenza in healthy adults: systematic review and meta-analysis. BMJ 2009, 339:b5106. OpenURL
  133. The influence of the pharmaceutical industry; formal minutes, oral and written evidence. Volume 2. London: Stationery Office; 2005. OpenURL[House of Commons, Health Committee (Series Editor): Report of session 2004-05; vol 4]
  134. Cochrane Injuries Group Albumin Reviewers: Human albumin administration in critically ill patients: systematic review of randomised controlled trials. BMJ 1998, 317:235-240. OpenURL
  135. McCarthy M: Company sought to block paper’s publication. Lancet 2000, 356:1659.
  136. Man-Son-Hing M, Wells G, Lau A: Quinine for nocturnal leg cramps: a meta-analysis including unpublished data. J Gen Intern Med 1998, 13:600-606. OpenURL
  137. Marshall E: Is data-hoarding slowing the assault on pathogens? Science 1997, 275:777-780. OpenURL
  138. Campbell EG, Clarridge BR, Gokhale M, Birenbaum L, Hilgartner S, Holtzman NA, Blumenthal D: Data withholding in academic genetics: evidence from a national survey. JAMA 2002, 287:473-480. OpenURL
  139. Misakian AL, Bero LA: Publication bias and research on passive smoking: comparison of published and unpublished studies. JAMA 1998, 280:250-253. OpenURL
  140. Barnes DE, Bero LA: Why review articles on the health effects of passive smoking reach different conclusions. JAMA 1998, 279:1566-1570. OpenURL
  141. Hilts PJ: Philip Morris blocked paper showing addiction, panel finds. New York Times 1994, A7. OpenURL
  142. Hilts PJ: Scientists say Philip Morris withheld nicotine findings. New York Times 1994, A1-A7. OpenURL
  143. Anderson HR, Atkinson RW, Peacock JL, Sweeting MJ, Marston L: Ambient particulate matter and health effects: publication bias in studies of short-term associations. Epidemiology 2005, 16:155-163. OpenURL
  144. Peinemann F, McGauran N, Sauerland S, Lange S: Negative pressure wound therapy: potential publication bias caused by lack of access to unpublished study results data. BMC Med Res Methodol 2008, 8:4. OpenURL
  145. McAuley L, Pham B, Tugwell P, Moher D: Does the inclusion of grey literature influence estimates of intervention effectiveness reported in meta-analyses? Lancet 2000, 356:1228-1231. OpenURL
  146. Hopewell S, McDonald S, Clarke M, Egger M: Grey literature in meta-analyses of randomized trials of health care interventions. Cochrane Database Syst Rev 2007, (2):MR000010. OpenURL
  147. Chalmers I: Underreporting research is scientific misconduct. JAMA 1990, 263:1405-1408. OpenURL
  148. World Medical Association: Declaration of Helsinki: ethical principles for medical research involving human subjects. []
  149. Pearn J: Publication: an ethical imperative. BMJ 1995, 310:1313-1315. OpenURL
  150. The Nuremberg code In Trials of war criminals before the Nuremberg Military Tribunals under Control Council Law no10. Volume 2. Washington, D.C.: US Government Printing Office; 1949:181-182. OpenURL
  151. Healy D: Did regulators fail over selective serotonin reuptake inhibitors? BMJ 2006, 333:92-95. OpenURL
  152. Topol EJ: Failing the public health: rofecoxib, Merck, and the FDA. N Engl J Med 2004, 351:1707-1709. OpenURL
  153. Rennie D: When evidence isn’t: trials, drug companies and the FDA. J Law Policy 2007, 15:991-1012. OpenURL
  154. Dickersin K, Rennie D: Registering clinical trials. JAMA 2003, 290:516-523.
  155. Tse T, Williams RJ, Zarin DA: Update on Registration of Clinical Trials in Chest 2009, 136:304-305. OpenURL
  156. Tse T, Williams RJ, Zarin DA: Reporting "basic results" in Chest 2009, 136:295-303. OpenURL
  157. WHO clinical trials initiative to protect the public Bull World Health Organ 2006, 84:10-11.
  158. De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJ, Schroeder TV, Sox HC, Weyden MB, International Committee of Medical Journal Editors: Clinical trial registration: a statement from the International Committee of Medical Journal Editors. N Engl J Med 2004, 351:1250-1251. OpenURL
  159. Deutsches Cochrane Zentrum, Deutsches Netzwerk Evidenzbasierte Medizin: Stellungnahme [Comment]. [http:/ / netzwerkarbeit/ images/ stellungnahme_anhoerung_probandensc hutz.pdf]
  160. Krleza-Jeric K: International dialogue on the Public Reporting Of Clinical Trial Outcome and Results: PROCTOR meeting. Croat Med J 2008, 49:267-268. OpenURL
  161. Krleza-Jeric K, Chan AW, Dickersin K, Sim I, Grimshaw J, Gluud C: Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1). BMJ 2005, 330:956-958. OpenURL
  162. European Research Council: ERC Scientific Council guidelines on open access. []
  163. Groves T: Mandatory disclosure of trial results for drugs and devices. BMJ 2008, 336:170. OpenURL
  164. Steinbrook R: Public access to NIH-funded research. N Engl J Med 2005, 352:1739-1741. OpenURL
  165. Dickersin K: Report from the Panel on the Case for Registers of Clinical Trials at the Eighth Annual Meeting of the Society for Clinical Trials. Control Clin Trials 1988, 9:76-81.
  166. De Angelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C: Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors. N Engl J Med 2005, 352:2436-2438. OpenURL
  167. Laine C, Horton R, DeAngelis CD, Drazen JM, Frizelle FA, Godlee F, Haug C, Hebert PC, Kotzin S, Marusic A, Sahni P, Schroeder TV, Sox HC, Weyden MB, Verheugt FW: Clinical trial registration–looking back and moving ahead. N Engl J Med 2007, 356:2734-2736. OpenURL
  168. Krleza-Jeric K: Clinical trial registration: the differing views of industry, the WHO, and the Ottawa Group. PLoS Med 2005, 2:e378.
  169. Food and Drug Administration: FDA Amendments Act (FDAAA) of 2007, public law no. 110-85 §801. [http:/ / cgi-bin/ getdoc.cgi?dbname=110_cong_public_l aws&docid=f:publ085.110.pdf]
  170. Wood AJJ: Progress and deficiencies in the registration of clinical trials. N Engl J Med 2009, 360:824-830. OpenURL
  171. European Medicines Agency: EMEA launches EudraCT database. []
  172. Smyth RL: Making information about clinical trials publicly available. BMJ 2009, 338:b2473.
  173. Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending regulation (EEC) no 1768/92, directive 2001/20/EC, directive 2001/83/EC and regulation (EC) No 726/2004 Official J Eur Commun 2006, 49:L378/1-L378/19.
  174. European Commission: List of fields to be made public from EudraCT for paediatric clinical trials in accordance with article 41 of regulation (EC) no 1901/2006 and its implementing guideline 2009/C28/01. [http:/ / enterprise/ pharmaceuticals/ eudralex/ vol-10/ 2009_02_04_guidelines_paed.pdf]
  175. European Commission: List of fields contained in the ‘EudraCT’ clinical trials database to be made public, in accordance with Article 57(2) of Regulation (EC) No 726/2004 and its implementing guideline 2008/c168/021. [http:/ / enterprise/ pharmaceuticals/ eudralex/ vol-10/ 2009_02_04_guideline.pdf]
  176. Committee on Government Reform: A citizen’s guide on using the Freedom of Information Act and the Privacy Act of 1974 to request government records. []
  177. Food and Drug Administration: Executive summary of the Food and Drug Administration’s consumer roundtable on consumer protection priorities. []
  178. Turner EH: Closing a loophole in the FDA Amendments Act. Science 2008, 322:44-46. OpenURL
  179. Pharmaceutical Research and Manufacturers of America: PhRMA clinical trial registry proposal. []
  180. Principles on the conduct of clinical trials and communication of clinical trial results. Washington DC: Pharmaceutical Research and Manufacturers of America; 2002. OpenURL
  181. International Federation of Pharmaceutical Manufacturers & Associations: Joint position on the disclosure of clinical trial information via clinical trial registries and databases. []
  182. International Federation of Pharmaceutical Manufacturers & Associations: Joint position on the disclosure of clinical trial information via clinical trial registries and databases. []
  183. Verband Forschender Arzneimittelhersteller: VFA-Positionspapier zum Thema "publication bias" [VFA position paper on the subject of "publication bias"]. Berlin: VFA; 2008. OpenURL
  184. Verband Forschender Arzneimittelhersteller: VFA-Positionspapier zum Thema "publication bias" [VFA position paper on the subject of "publication bias"]. [http:/ / download/ SAVE/ de/ presse/ positionen/ pos-publication-bias.html/ pos-publication-bias.pdf]
  185. Mathew SJ, Charney DS: Publication bias and the efficacy of antidepressants. Am J Psychiatry 2009, 166:140-145.
  186. Abbott A: British panel bans use of antidepressant to treat children. Nature 2003, 423:792.
  187. Mitka M: FDA alert on antidepressants for youth. JAMA 2003, 290:2534. OpenURL
  188. Garland EJ: Facing the evidence: antidepressant treatment in children and adolescents. CMAJ 2004, 170:489-491. OpenURL
  189. Herxheimer A, Mintzes B: Antidepressants and adverse effects in young patients: uncovering the evidence. CMAJ 2004, 170:487-489.
  190. Dyer O: GlaxoSmithKline faces US lawsuit over concealment of trial results. BMJ 2004, 328:1395. OpenURL
  191. Jureidini JN, McHenry LB, Mansfield PR: Clinical trials and drug promotion: selective reporting of study 329. Int J Risk Safety Med 2008, 73-81. OpenURL
  192. Institute for Quality and Efficiency in Health Care: Preliminary report on antidepressants published. []
  193. Steinman MA, Bero LA, Chren MM, Landefeld CS: Narrative review: the promotion of gabapentin: an analysis of internal industry documents. Ann Intern Med 2006, 145:284-293. OpenURL
  194. Steinman MA, Harper GM, Chren MM, Landefeld CS, Bero LA: Characteristics and impact of drug detailing for gabapentin. PLoS Med 2007, 4:e134.
  195. Landefeld CS, Steinman MA: The Neurontin legacy: marketing through misinformation and manipulation. Engl J Med 2009, 360:103-106. OpenURL
  196. Mack A: Examination of the evidence for off-label use of gabapentin. J Manag Care Pharm 2003, 9:559-568. OpenURL
  197. Petersen M: Memos cast shadow on drug’s promotion. New York Times 2002, C2. OpenURL
  198. U.S. Department of Justice: Warner-Lambert to pay $430 million to resolve criminal & civil health care liability relating to off-label promotion. []
  199. Feeley J, Cronin Fisk M: AstraZeneca Seroquel studies ‘buried,’ papers show (update 3). []
  200. Milford P: AstraZeneca may link Seroquel, diabetes, doctor says (update 1). [] OpenURLLast update 11 Mar 2009 [accessed 19 Mar 2010]
  201. Whalen J: AstraZeneca chalks up Seroquel dismissal in State Court. [http:/ / health/ 2009/ 06/ 10/ astrazeneca-chalks-up-seroquel-dism issal-in-state-court] Wall Street Journal Health Blog [Online] 2009. OpenURL
  202. Kapczinski F, Lima MS, Souza JS, Schmitt R: Antidepressants for generalized anxiety disorder. Cochrane Database Syst Rev 2003, (2):CD003592. OpenURL
  203. Bang LM, Keating GM: Paroxetine controlled release. CNS Drugs 2004, 18:355-364. OpenURL
  204. Lenzer J: NIH secrets: study break. []
  205. Ray WA, Stein CM, Daugherty JR, Hall K, Arbogast PG, Griffin MR: COX-2 selective non-steroidal anti-inflammatory drugs and risk of serious coronary heart disease. Lancet 2002, 360:1071-1073. OpenURL
  206. Juni P, Nartey L, Reichenbach S, Sterchi R, Dieppe PA, Egger M: Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. Lancet 2004, 364:2021-2029. OpenURL
  207. Curfman GD, Morrissey S, Drazen JM: 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. N Engl J Med 2005, 353:2813-2814.
  208. Waxman HA: The lessons of Vioxx: drug safety and sales. N Engl J Med 2005, 352:2576-2578. OpenURL
  209. Waxman HA: The Marketing of Vioxx to Physicians (Memorandum to Democratic members of the Government Reform Committee). 2005. OpenURL
  210. Krumholz HM, Ross JS, Presler AH, Egilman DS: What have we learnt from Vioxx? BMJ 2007, 334:120-123. OpenURL
  211. Charatan F: Merck to pay $58 m in settlement over rofecoxib advertising. BMJ 2008, 336:1208-1209.
  212. DeAngelis CD, Fontanarosa PB: Impugning the integrity of medical science: the adverse effects of industry influence. JAMA 2008, 299:1833-1835. OpenURL
  213. Hill KP, Ross JS, Egilman DS, Krumholz HM: The ADVANTAGE seeding trial: a review of internal documents. Ann Intern Med 2008, 149:251-258. OpenURL
  214. Ross JS, Hill KP, Egilman DS, Krumholz HM: Guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation. JAMA 2008, 299:1800-1812. OpenURL
  215. Moynihan R: Merck defends Vioxx in court, as publisher apologises for fake journal. BMJ 2009, 338:b1914. OpenURL
  216. West RR, Jones DA: Publication bias in statistical overview of trials: example of psychological rehabilitation following myocardial infarction [Abstract]. Proceedings of the 2nd International Conference on the Scientific Basis of Health Services and 5th Annual Cochrane Colloquium; 1997 Oct 8-12; Amsterdam. Amsterdam 1999, 17. OpenURL
  217. Mangano DT, Tudor IC, Dietzel C: The risk associated with aprotinin in cardiac surgery. N Engl J Med 2006, 354:353-365.
  218. Karkouti K, Beattie WS, Dattilo KM, McCluskey SA, Ghannam M, Hamdy A, Wijeysundera DN, Fedorko L, Yau TM: A propensity score case-control comparison of aprotinin and tranexamic acid in high-transfusion-risk cardiac surgery. Transfusion (Paris) 2006, 46:327-338. OpenURL
  219. Hauser RG, Maron BJ: Lessons from the failure and recall of an implantable cardioverter-defibrillator. Circulation 2005, 112:2040-2042. OpenURL
  220. Kesselheim AS, Mello MM: Confidentiality laws and secrecy in medical research: improving public access to data on drug safety. Health Aff (Millwood) 2007, 26:483-491. OpenURL
  221. Sackner-Bernstein JD, Kowalski M, Fox M, Aaronson K: Short-term risk of death after treatment with nesiritide for decompensated heart failure: a pooled analysis of randomized controlled trials. JAMA 2005, 293:1900-1905. OpenURL
  222. Camilleri M, Northcutt AR, Kong S, Dukes GE, McSorley D, Mangel AW: Efficacy and safety of alosetron in women with irritable bowel syndrome: a randomised, placebo-controlled trial. Lancet 2000, 355:1035-1040. OpenURL
  223. Horton R: Lotronex and the FDA: a fatal erosion of integrity. Lancet 2001, 357:1544-1545. OpenURL
  224. Lenzer J: FDA warns that antidepressants may increase suicidality in adults. BMJ 2005, 331:70. OpenURL
  225. Lenzer J: Drug secrets: what the FDA isn’t telling. [] Slate Magazine 2005. OpenURL
  226. Saunders MC, Dick JS, Brown IM, McPherson K, Chalmers I: The effects of hospital admission for bed rest on the duration of twin pregnancy: a randomised trial. Lancet 1985, 2:793-795. OpenURL
  227. Nissen SE: The DREAM trial. Lancet 2006, 368:2049. OpenURL
  228. Drazen JM, Morrissey S, Curfman GD: Rosiglitazone: continued uncertainty about safety. N Engl J Med 2007, 357:63-64.
  229. Home PD, Pocock SJ, Beck-Nielsen H, Gomis R, Hanefeld M, Jones NP, Komajda M, McMurray JJ: Rosiglitazone evaluated for cardiovascular outcomes: an interim analysis. N Engl J Med 2007, 357:28-38. OpenURL
  230. Nathan DM: Rosiglitazone and cardiotoxicity: weighing the evidence. N Engl J Med 2007, 357:64-66. OpenURL
  231. Psaty BM, Furberg CD: The record on rosiglitazone and the risk of myocardial infarction. N Engl J Med 2007, 357:67-69.
  232. Psaty BM, Furberg CD: Rosiglitazone and cardiovascular risk. N Engl J Med 2007, 356:2522-2524.
  233. Rosen CJ: The rosiglitazone story: lessons from an FDA Advisory Committee meeting. N Engl J Med 2007, 357:844-846. OpenURL
  234. Singh S, Loke YK, Furberg CD: Long-term risk of cardiovascular events with rosiglitazone: a meta-analysis. AMA 2007, 298:1189-1195.
  235. Shuster JJ, Schatz DA: The rosiglitazone meta-analysis: lessons for the future. Diabetes Care 2008, 31:e10. OpenURL
  236. Friedrich JO, Beyene J, Adhikari NK: Rosiglitazone: can meta-analysis accurately estimate excess cardiovascular risk given the available data? Re-analysis of randomized trials using various methodologic approaches. BMC Res Notes 2009, 2:5. OpenURL
  237. Home PD, Pocock SJ, Beck-Nielsen H, Curtis PS, Gomis R, Hanefeld M, Jones NP, Komajda M, McMurray JJ: Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial. Lancet 2009, 373:2125-2135. OpenURL
  238. Merck/Schering-Plough Pharmaceuticals: Merck/Schering-Plough Pharmaceuticals provides results of the ENHANCE trial. [http:/ / msppharma/ documents/ press_release/ ENHANCE_news_release_1-14-08.pdf]
  239. Greenland P, Lloyd-Jones D: Critical lessons from the ENHANCE trial. JAMA 2008, 299:953-955.
  240. Lenzer J: Unreported cholesterol drug data released by company. BMJ 2008, 336:180-181.
  241. Berenson A: Data about Zetia risks was not fully revealed. New York Times 2007. OpenURL
  242. Furberg CD, Pitt B: Withdrawal of cerivastatin from the world market. Curr Control Trials Cardiovasc Med 2001, 2:205-207. OpenURL
  243. Wooltorton E: Bayer pulls cerivastatin (Baycol) from market. CMAJ 2001, 165:632. OpenURL
  244. Marwick C: Bayer is forced to release documents over withdrawal of cerivastatin. BMJ 2003, 326:518. OpenURL
  245. Piorkowski JD Jr: Bayer’s response to "potential for conflict of interest in the evaluation of suspected adverse drug reactions: use of cerivastatin and risk of rhabdomyolysis". JAMA 2004, 292:2655-2657.
  246. Zinberg DS: A cautionary tale. Science 1996, 273:411.
  247. Begg CB, Berlin JA: Publication bias and dissemination of clinical research. J Natl Cancer Inst 1989, 81:107-115. OpenURL
  248. Nathan DG, Weatherall DJ: Academia and industry: lessons from the unfortunate events in Toronto. Lancet 1999, 353:771-772.
  249. Harris G: Approval of antibiotic worried safety officials. New York Times 2006. OpenURL
  250. Ross DB: The FDA and the case of Ketek. N Engl J Med 2007, 356:1601-1604. OpenURL
  251. Johansen HK, Gotzsche PC: Problems in the design and reporting of trials of antifungal agents encountered during meta-analysis. JAMA 1999, 282:1752-1759. OpenURL
  252. McKenzie R, Fried MW, Sallie R, Conjeevaram H, Di Bisceglie AM, Park Y, Savarese B, Kleiner D, Tsokos M, Luciano C, et al.: Hepatic failure and lactic acidosis due to fialuridine (FIAU), an investigational nucleoside analogue for chronic hepatitis B. N Engl J Med 1995 , 333:1099-1105. OpenURL
  253. Blumsohn A: Authorship, ghostscience, access to data and control of the pharmaceutical scientific literature: who stands behind the word? Prof Ethics Rep 2006, 19:1-4. OpenURL
  254. Bracken MB, Shepard MJ, Holford TR, Leo-Summers L, Aldrich EF, Fazl M, Fehlings M, Herr DL, Hitchon PW, Marshall LF, Nockels RP, Pascale V, Perot PL Jr, Piepmeier J, Sonntag VK, Wagner F, Wilberger JE, Winn HR, Young W: Administration of methylprednisolone for 24 or 48 hours or tirilazad mesylate for 48 hours in the treatment of acute spinal cord injury: results of the Third National Acute Spinal Cord Injury Randomized Controlled Trial. JAMA 1997, 277:1597-1604
modificado el 28 de noviembre de 2013