CNS Drugs

, Volume 27, Issue 6, pp 457–468 | Cite as

Publication Bias, with a Focus on Psychiatry: Causes and Solutions

Review Article

Abstract

Publication bias undermines the integrity of the evidence base by inflating apparent drug efficacy and minimizing drug harms, thus skewing the risk–benefit ratio. This paper reviews the topic of publication bias with a focus on drugs prescribed for psychiatric conditions, especially depression, schizophrenia, bipolar disorder, and autism. Publication bias is pervasive; although psychiatry/psychology may be the most seriously afflicted field, it occurs throughout medicine and science. Responsibility lies with various parties (authors as well as journals, academia as well as industry), so the motives appear to extend beyond the financial interests of drug companies. The desire for success, in combination with cognitive biases, can also influence academic authors and journals. Amid the flood of new medical information coming out each day, the attention of the news media and academic community is more likely to be captured by studies whose results are positive or newsworthy. In the peer review system, a fundamental flaw arises from the fact that authors usually write manuscripts after they know the results. This allows hindsight and other biases to come into play, so data can be “tortured until they confess” (a detailed example is given). If a “publishable” result cannot be achieved, non-publication remains an option. To address publication bias, various measures have been undertaken, including registries of clinical trials. Drug regulatory agencies can provide valuable unpublished data. It is suggested that journals borrow from the FDA review model. Because the significance of study results biases reviewers, results should be excluded from review until after a preliminary judgment of study scientific quality has been rendered, based on the original study protocol. Protocol publication can further enhance the credibility of the published literature.

References

  1. 1.
    Dickersin K. The existence of publication bias and risk factors for its occurrence. JAMA. 1990;263:1385–9.PubMedCrossRefGoogle Scholar
  2. 2.
    Rosenthal R. The file drawer problem and tolerance for null results. Psychol Bull. 1979;86:638–41.CrossRefGoogle Scholar
  3. 3.
    Chan A-W, Krleza-Jerić K, Schmid I, Altman DG. Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research. CMAJ. 2004;171:735–40. doi:10.1503/cmaj.1041086.PubMedCentralPubMedCrossRefGoogle Scholar
  4. 4.
    Chan A-W, Altman DG. Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors. BMJ. 2005;330:753. doi:10.1136/bmj.38356.424606.8F.PubMedCrossRefGoogle Scholar
  5. 5.
    Vedula SS, Goldman PS, Rona IJ, Greene TM, Dickersin K. Implementation of a publication strategy in the context of reporting biases. A case study based on new documents from Neurontin® litigation. Trials. 2012;13:136. doi:10.1186/1745-6215-13-136.PubMedCentralPubMedCrossRefGoogle Scholar
  6. 6.
    Boutron I, Dutton S, Ravaud P, Altman DG. Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes. JAMA. 2010;303:2058–64. doi:10.1001/jama.2010.651.PubMedCrossRefGoogle Scholar
  7. 7.
    Spielmans GI, Parry PI. From evidence-based medicine to marketing-based medicine: evidence from internal industry documents. Bioethical Inquiry. 2010;7:13–29. doi:10.1007/s11673-010-9208-8.CrossRefGoogle Scholar
  8. 8.
    Chan A-W. Bias, spin, and misreporting: time for full access to trial protocols and results. PLoS Med. 2008;5:e230. doi:10.1371/journal.pmed.0050230.PubMedCentralPubMedCrossRefGoogle Scholar
  9. 9.
    Reyes MM, Panza KE, Martin A, Bloch MH. Time-lag bias in trials of pediatric antidepressants: a systematic review and meta-analysis. J Am Acad Child Adolesc Psychiatry. 2011;50:63–72.PubMedCentralPubMedCrossRefGoogle Scholar
  10. 10.
    Ioannidis JP. Effect of the statistical significance of results on the time to completion and publication of randomized efficacy trials. JAMA. 1998;279:281–6.PubMedCrossRefGoogle Scholar
  11. 11.
    Stern JM, Simes RJ. Publication bias: evidence of delayed publication in a cohort study of clinical research projects. BMJ. 1997;315:640–5.PubMedCrossRefGoogle Scholar
  12. 12.
    Spielmans GI, Biehn TL, Sawrey DL. A case study of salami slicing: pooled analyses of duloxetine for depression. Psychother Psychosom. 2010;79:97–106. doi:10.1159/000270917.PubMedCrossRefGoogle Scholar
  13. 13.
    Turner EH (2009) Multiple publication of positive vs. negative trial results in review articles: influence on apparent “weight of the evidence.” In: Sixth International Congress on Peer Review and Biomedical Publication, 2009 Sept 10–12, Vancouver, BC, Canada. http://www.peerreviewcongress.org/abstracts_2009.html#58.
  14. 14.
    von Elm E, Poglia G, Walder B, Tramèr MR. Different patterns of duplicate publication: an analysis of articles used in systematic reviews. JAMA. 2004;291:974–80. doi:10.1001/jama.291.8.974.CrossRefGoogle Scholar
  15. 15.
    Melander H. Evidence b(i)ased medicine—selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. BMJ. 2003;326:1171–3. doi:10.1136/bmj.326.7400.1171.PubMedCrossRefGoogle Scholar
  16. 16.
    Ben-Shlomo Y, Smith GD. “Place of publication” bias? BMJ. 1994;309:274.PubMedCrossRefGoogle Scholar
  17. 17.
    Katerndahl DA. Citation bias: supporting your case in the extreme. Fam Pract Res J. 1994;14:107–8.PubMedGoogle Scholar
  18. 18.
    Jannot A-S, Agoritsas T, Gayet-Ageron A, Perneger TV. Citation bias favoring statistically significant studies was present in medical research. J Clin Epidemiol. 2013;66:296–301. doi:10.1016/j.jclinepi.2012.09.015.PubMedCrossRefGoogle Scholar
  19. 19.
    Chapman S, Ragg M, McGeechan K. Citation bias in reported smoking prevalence in people with schizophrenia. Aust N Z J Psychiatry. 2009;43:277–82. doi:10.1080/00048670802653372.PubMedCrossRefGoogle Scholar
  20. 20.
    Carroll L. Alice’s adventures in wonderland. London: Macmillan; 1865.Google Scholar
  21. 21.
    Martinez B. Spitzer charges Glaxo concealed Paxil data. Wall Str J 2004 June 3.Google Scholar
  22. 22.
    Ioannidis JPA, Evans SJW, Gøtzsche PC, O’Neill RT, Altman DG, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med. 2004;141:781–8.PubMedCrossRefGoogle Scholar
  23. 23.
    Fanelli D. Negative results are disappearing from most disciplines and countries. Scientometrics. 2012;90(3):891–904.Google Scholar
  24. 24.
    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;358:252–60.PubMedCrossRefGoogle Scholar
  25. 25.
    Whittington CJ, Kendall T, Fonagy P, Cottrell D, Cotgrove A, et al. Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data. Lancet. 2004;363:1341–5. doi:10.1016/S0140-6736(04)16043-1.PubMedCrossRefGoogle Scholar
  26. 26.
    Keller MB, Ryan ND, Strober M, Klein RG, Kutcher SP, et al. Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial. J Am Acad Child Adolesc Psychiatry. 2001;40:762–72. doi:10.1097/00004583-200107000-00010.PubMedCrossRefGoogle Scholar
  27. 27.
    Jureidini J, Tonkin A. Paroxetine in major depression. J Am Acad Child Adolesc Psychiatry. 2003;42:514 (author reply 514–5). doi:10.1097/01.CHI.0000046825.95464.DA.
  28. 28.
    Jureidini J, McHenry L, Mansfield P. Clinical trials and drug promotion: Selective reporting of study 329. Int J Risk Saf Med. 2008;20:73–81.Google Scholar
  29. 29.
    Eyding D, Lelgemann M, Grouven U, Härter M, Kromp M, et al. Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials. BMJ. 2010;341:c4737.PubMedCentralPubMedCrossRefGoogle Scholar
  30. 30.
    Turner EH. Reboxetine in depression. All the relevant data? BMJ. 2010;341:c6487.PubMedCrossRefGoogle Scholar
  31. 31.
    Howland RH. Publication bias and outcome reporting bias: agomelatine as a case example. J Psychosoc Nurs Ment Health Serv. 2011;49:11–4. doi:10.3928/02793695-20110809-01.PubMedCrossRefGoogle Scholar
  32. 32.
    Heres S, Davis J, Maino K, Jetzinger E, Kissling W, et al. 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;163:185–94. doi:10.1176/appi.ajp.163.2.185.PubMedCrossRefGoogle Scholar
  33. 33.
    Turner EH, Knoepflmacher D, Shapley L. Publication bias in antipsychotic trials: an analysis of efficacy comparing the published literature to the US Food and Drug Administration Database. PLoS Med. 2012;9:e1001189. doi:10.1371/journal.pmed.1001189. http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001189.
  34. 34.
    Tsai A, Rosenlicht N, Jureidini J, Parry P. Aripiprazole in the maintenance treatment of bipolar disorder: a critical review of the evidence and its dissemination into the scientific literature. PLoS Med, 2011;8:e1000434. http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000434.
  35. 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.PubMedCentralPubMedGoogle Scholar
  36. 36.
    Ghaemi SN. The failure to know what isn’t known: negative publication bias with lamotrigine and a glimpse inside peer review. Evid Based Ment Health. 2009;12:65–8.PubMedCrossRefGoogle Scholar
  37. 37.
    Calabrese JR, Bowden CL, Sachs GS, Ascher JA, Monaghan E, et al. A double-blind placebo-controlled study of lamotrigine monotherapy in outpatients with bipolar I depression. Lamictal 602 Study Group. J Clin Psychiatry. 1999;60:79–88.PubMedCrossRefGoogle Scholar
  38. 38.
    Vedula SS, Li T, Dickersin K. Differences in reporting of analyses in internal company documents versus published trial reports: comparisons in industry-sponsored trials in off-label uses of gabapentin. PLoS Med. 2013;10:e1001378. doi:10.1371/journal.pmed.1001378. http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001378.
  39. 39.
    Chace MJ, Zhang F, Fullerton CA, Huskamp HA, Gilden D, et al. Intended and unintended consequences of the gabapentin off-label marketing lawsuit among patients with bipolar disorder. J Clin Psychiatry. 2012;73:1388–94. doi:10.4088/JCP.12m07794.PubMedCrossRefGoogle Scholar
  40. 40.
    Fullerton CA, Busch AB, Frank RG. The rise and fall of gabapentin for bipolar disorder: a case study on off-label pharmaceutical diffusion. Med Care. 2010;48:372–9. doi:10.1097/MLR.0b013e3181ca404e.PubMedCrossRefGoogle Scholar
  41. 41.
    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;361:1963–71. doi:10.1056/NEJMsa0906126.PubMedCrossRefGoogle Scholar
  42. 42.
    Landefeld CS, Steinman MA. The Neurontin legacy—marketing through misinformation and manipulation. N Engl J Med. 2009;360:103–6. doi:10.1056/NEJMp0808659.PubMedCrossRefGoogle Scholar
  43. 43.
    Steinman MA, Bero LA, Chren M-M, Landefeld CS. Narrative review: the promotion of gabapentin: an analysis of internal industry documents. Ann Intern Med. 2006;145:284–93.PubMedCrossRefGoogle Scholar
  44. 44.
    Carrasco M, Volkmar FR, Bloch MH. Pharmacologic treatment of repetitive behaviors in autism spectrum disorders: evidence of publication bias. Pediatrics. 2012;129:e1301–10. doi:10.1542/peds.2011-3285.PubMedCrossRefGoogle Scholar
  45. 45.
    McGauran N, Wieseler B, Kreis J, Schüler Y-B, Kölsch H, et al. Reporting bias in medical research—a narrative review. Trials. 2010;11:37. doi:10.1186/1745-6215-11-37.PubMedCentralPubMedCrossRefGoogle Scholar
  46. 46.
    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 (discussion e217). doi:10.1371/journal.pmed.0050217. http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.0050217.
  47. 47.
    Hart B, Lundh A, Bero L. Effect of reporting bias on meta-analyses of drug trials: reanalysis of meta-analyses. BMJ. 2012;344:d7202. doi:10.1136/bmj.d7202.PubMedCrossRefGoogle Scholar
  48. 48.
    Yong E. Replication studies: bad copy. Nature. 2012;485:298–300. doi:10.1038/485298a.PubMedCrossRefGoogle Scholar
  49. 49.
    Angell M. The truth about the drug companies: how they deceive us and what to do about it. New York: Random House; 2005.Google Scholar
  50. 50.
    Moynihan R. Key opinion leaders: independent experts or drug representatives in disguise? BMJ. 2008;336:1402–3. doi:10.1136/bmj.39575.675787.651.PubMedCrossRefGoogle Scholar
  51. 51.
    Kern DG. Confidentiality agreements and scientific independence. Med Decis Making. 1998;18:239.PubMedGoogle Scholar
  52. 52.
    Rochon PA, Sekeres M, Hoey J, Lexchin J, Ferris LE, et al. Investigator experiences with financial conflicts of interest in clinical trials. Trials. 2011;12:9. doi:10.1186/1745-6215-12-9.PubMedCentralPubMedCrossRefGoogle Scholar
  53. 53.
    Safer DJ. Design and reporting modifications in industry-sponsored comparative psychopharmacology trials. J Nerv Ment Dis. 2002;190:583–92.PubMedCrossRefGoogle Scholar
  54. 54.
    Lundh A, Sismondo S, Lexchin J, Busuioc OA, Bero L. Industry sponsorship and research outcome. Cochrane Database Syst Rev. 2012;12:MR000033. doi:10.1002/14651858.MR000033.pub2.
  55. 55.
    Dickersin K, Min YI. NIH clinical trials and publication bias. Online J Curr Clin Trials 1993;50.Google Scholar
  56. 56.
    Ross JS, Tse T, Zarin DA, Xu H, Zhou L, et al. Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis. BMJ. 2012;344:d7292. doi:10.1136/bmj.d7292.PubMedCentralPubMedCrossRefGoogle Scholar
  57. 57.
    Matthews GA, Dumville JC, Hewitt CE, Torgerson DJ. Retrospective cohort study highlighted outcome reporting bias in UK publicly funded trials. J Clin Epidemiol. 2011;64:1317–24. doi:10.1016/j.jclinepi.2011.03.013.PubMedCrossRefGoogle Scholar
  58. 58.
    Fanelli D. Do pressures to publish increase scientists’ bias? An empirical support from US States Data. PLoS ONE. 2010;5:e10271. doi:10.1371/journal.pone.0010271. http://www.plosone.org/article/info:doi/10.1371/journal.pone.0010271.
  59. 59.
    Blank H, Musch J, Pohl R. Hindsight bias: on being wise after the event. Soc Cognit. 2007;25:1.CrossRefGoogle Scholar
  60. 60.
    Kerr N. HARKing: hypothesizing after the results are known. Person Soc Psychol Rev. 1998;2:196.CrossRefGoogle Scholar
  61. 61.
    Moore A. Prose and principle: getting your message across: more than detailed cataloguing of research findings, emphasis of principles within a narrative engages the readers of reviews. Bioessays. 2011;33:85. doi:10.1002/bies.201190000.PubMedCrossRefGoogle Scholar
  62. 62.
    Bacon F. In: Jardine L, Silverthorne M, editors. The new organon. Cambridge: Cambridge University Press; 2000.Google Scholar
  63. 63.
    Makhinson M. Biases in medication prescribing: the case of second-generation antipsychotics. J Psychiatr Pract. 2010;16:15–21. doi:10.1097/01.pra.0000367774.11260.e4.PubMedCrossRefGoogle Scholar
  64. 64.
    Chalmers I. Underreporting research is scientific misconduct. JAMA. 1990;263:1405–8.PubMedCrossRefGoogle Scholar
  65. 65.
    Bastian H, Glasziou P, Chalmers I. Seventy-five trials and eleven systematic reviews a day: how will we ever keep up? PLoS Med. 2010;7:e1000326. doi:10.1371/journal.pmed.1000326.PubMedCentralPubMedCrossRefGoogle Scholar
  66. 66.
    Lariviere V, Gingras Y. The impact factor’s Matthew effect: a natural experiment in bibliometrics. J Am Soc Inf Sci Technol. 2010;61:424–7.CrossRefGoogle Scholar
  67. 67.
    Emerson GB, Warme WJ, Wolf FM, Heckman JD, Brand RA, et al. Testing for the presence of positive-outcome bias in peer review: a randomized controlled trial. Arch Intern Med. 2010;170:1934–9. doi:10.1001/archinternmed.2010.406.PubMedCrossRefGoogle Scholar
  68. 68.
    Siontis KC, Evangelou E, Ioannidis JP. Magnitude of effects in clinical trials published in high-impact general medical journals. Int J Epidemiol. 2011;40:1280–91. doi:10.1093/ije/dyr095.PubMedCrossRefGoogle Scholar
  69. 69.
    Horton R. The refiguration of medical thought. Lancet. 2000;356:2–4. http://www.thelancet.com/lancet-information-for-authors/article-types-manuscript-requirements.Google Scholar
  70. 70.
    Evangelou E, Siontis KC, Pfeiffer T, Ioannidis JPA. Perceived information gain from randomized trials correlates with publication in high-impact factor journals. J Clin Epidemiol. 2012;65(12):1274–81. doi:10.1016/j.jclinepi.2012.06.009.Google Scholar
  71. 71.
    Lundh A, Barbateskovic M, Hróbjartsson A, Gøtzsche P. Conflicts of interest at medical journals: the influence of industry-supported randomised trials on journal impact factors and revenue—cohort study. PLoS Med. 2010;7:e1000354EP.Google Scholar
  72. 72.
    Huque MF, Sankoh AJ. A reviewer’s perspective on multiple endpoint issues in clinical trials. J Biopharm Stat. 1997;7:545–64.PubMedCrossRefGoogle Scholar
  73. 73.
    Austin PC, Mamdani MM, Juurlink DN, Hux JE. Testing multiple statistical hypotheses resulted in spurious associations: a study of astrological signs and health. J Clin Epidemiol. 2006;59:964–9. doi:10.1016/j.jclinepi.2006.01.012.PubMedCrossRefGoogle Scholar
  74. 74.
    Kubler-Ross E. On death and dying. New York: Scribner; 2011.Google Scholar
  75. 75.
    Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960;23:56.PubMedCrossRefGoogle Scholar
  76. 76.
    Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979;134:382–9.PubMedCrossRefGoogle Scholar
  77. 77.
    Bagby RM. The Hamilton Depression Rating Scale: has the gold standard become a lead weight? Am J Psychiatry. 2004;161:2163–77. doi:10.1176/appi.ajp.161.12.2163.PubMedCrossRefGoogle Scholar
  78. 78.
    Williams JB. A structured interview guide for the Hamilton Depression Rating Scale. Arch Gen Psychiatry. 1988;45:742–7.PubMedCrossRefGoogle Scholar
  79. 79.
    Nierenberg AA, Alpert JE, Gardner-Schuster EE, Seay S, Mischoulon D. Vagus nerve stimulation: 2-year outcomes for bipolar versus unipolar treatment-resistant depression. Biol Psychiatry. 2008;64:455–60. doi:10.1016/j.biopsych.2008.04.036.PubMedCrossRefGoogle Scholar
  80. 80.
    McIntyre R, Kennedy S, Bagby RM, Bakish D. Assessing full remission. J Psychiatry Neurosci. 2002;27:235–9.PubMedCentralPubMedGoogle Scholar
  81. 81.
    Bech P, Allerup P, Gram LF, Reisby N, Rosenberg R, et al. The Hamilton depression scale. Evaluation of objectivity using logistic models. Acta Psychiatr Scand. 1981;63:290–9.PubMedCrossRefGoogle Scholar
  82. 82.
    O’Sullivan RL, Fava M, Agustin C, Baer L, Rosenbaum JF. Sensitivity of the six-item Hamilton Depression Rating Scale. Acta Psychiatr Scand. 1997;95:379–84.PubMedCrossRefGoogle Scholar
  83. 83.
    Simmons JP, Nelson LD, Simonsohn U. False-positive psychology: undisclosed flexibility in data collection and analysis allows presenting anything as significant. Psychol Sci. 2011;22:1359–66. doi:10.1177/0956797611417632.PubMedCrossRefGoogle Scholar
  84. 84.
    Frank E, Prien RF, Jarrett RB, Keller MB, Kupfer DJ, et al. Conceptualization and rationale for consensus definitions of terms in major depressive disorder. Remission, recovery, relapse, and recurrence. Arch Gen Psychiatry. 1991;48:851–5.PubMedCrossRefGoogle Scholar
  85. 85.
    Zimmerman M, Chelminski I, Posternak M. A review of studies of the Montgomery–Asberg Depression Rating Scale in controls: implications for the definition of remission in treatment studies of depression. Int Clin Psychopharmacol. 2004;19:1.PubMedCrossRefGoogle Scholar
  86. 86.
    Fava M, Davidson KG. Definition and epidemiology of treatment-resistant depression. Psychiatr Clin North Am. 1996;19:179–200.PubMedCrossRefGoogle Scholar
  87. 87.
    Nierenberg AA, DeCecco LM. Definitions of antidepressant treatment response, remission, nonresponse, partial response, and other relevant outcomes: a focus on treatment-resistant depression. J Clin Psychiatry. 2001;62(Suppl 16):5–9.PubMedGoogle Scholar
  88. 88.
    Lenzer J. Unreported cholesterol drug data released by company. BMJ. 2008;336:180–1. doi:10.1136/bmj.39468.610775.DB.PubMedCrossRefGoogle Scholar
  89. 89.
    Turner E. Correction/clarification about FDA review documents. PLoS Med. 2005;2:e422 (author reply e423). doi:10.1371/journal.pmed.0020422.
  90. 90.
    Turner EH. A taxpayer-funded clinical trials registry and results database. PLoS Med. 2004;1:e60. http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0010060.
  91. 91.
    Siddiqui O, Hung HMJ, O’Neill R. MMRM vs. LOCF: a comprehensive comparison based on simulation study and 25 NDA datasets. J Biopharm Stat. 2009;19:227–46. doi:10.1080/10543400802609797.PubMedCrossRefGoogle Scholar
  92. 92.
    Office of New Drugs. Good review practice: attachment A: annotated clinical review template. 2010. http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/UCM236903.pdf.
  93. 93.
    Center for Drug Evaluation and Research, US Food and Drug Administration. Guideline for industry, structure and content of clinical study reports—ICH E3. 1996. p. 25–35. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm078749.pdf.
  94. 94.
    Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The ClinicalTrials.gov results database—update and key issues. N Engl J Med. 2011;364:852–60. doi:10.1056/NEJMsa1012065.PubMedCentralPubMedCrossRefGoogle Scholar
  95. 95.
    US Food and Drug Administration. Food and Drug Modernization Act of 1997 (FDAMA). 1997. p. 2295. http://www.gpo.gov/fdsys/pkg/PLAW-105publ115/html/PLAW-105publ115.htm.
  96. 96.
    Zarin DA, Tse T, Ide NC. Trial Registration at ClinicalTrials.gov between May and October 2005. N Engl J Med. 2005;353:2779–87. doi:10.1056/NEJMsa053234.PubMedCentralPubMedCrossRefGoogle Scholar
  97. 97.
    Topol EJ. Failing the public health—rofecoxib, Merck, and the FDA. N Engl J Med. 2004;351:1707–9.PubMedCrossRefGoogle Scholar
  98. 98.
    DeAngelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. JAMA. 2004;292:1363–4. doi:10.1001/jama.292.11.1363.PubMedCrossRefGoogle Scholar
  99. 99.
    Dickersin K, Rennie D. The evolution of trial registries and their use to assess the clinical trial enterprise. JAMA. 2012;307:1861–4. doi:10.1001/jama.2012.4230.PubMedCrossRefGoogle Scholar
  100. 100.
    Viergever RF, Ghersi D. The quality of registration of clinical trials. PLoS ONE. 2011;6:e14701. doi:10.1371/journal.pone.0014701.t003.PubMedCentralPubMedCrossRefGoogle Scholar
  101. 101.
    Dodd C. Fair access to Clinical Trials Act (FACT). 2005. http://olpa.od.nih.gov/tracking/109/senate_bills/session1/s-470.asp.
  102. 102.
    Dingell J. Food and Drug Administration Amendments Act of 2007 (FDAAA). 2007. http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf.
  103. 103.
    Prayle AP, Hurley MN, Smyth AR. Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study. BMJ. 2012;344:d7373. doi:10.1136/bmj.d7373.PubMedCrossRefGoogle Scholar
  104. 104.
    Zarin DA, Tse T. Moving toward transparency of clinical trials. Science. 2008;319:1340–2. doi:10.1126/science.1153632.PubMedCentralPubMedCrossRefGoogle Scholar
  105. 105.
    Turner EH. Closing a loophole in the FDA Amendments Act. Science. 2008;322:44–6.PubMedCrossRefGoogle Scholar
  106. 106.
    Tse T, Williams RJ, Zarin DA. Reporting “basic results” in ClinicalTrials.gov. Chest. 2009;136:295–303. doi:10.1378/chest.08-3022.PubMedCrossRefGoogle Scholar
  107. 107.
    Veitch E (2012) Silent takedown of the pharma trials database…and more. Speaking of Medicine. 2012 March 23. http://blogs.plos.org/speakingofmedicine/2012/03/23/silent-takedown-of-the-pharma-trials-database%E2%80%A6and-more/ (accessed 22 Nov 2012).
  108. 108.
    Mansi BA, Clark J, David FS, Gesell TM, Glasser S, et al. Ten recommendations for closing the credibility gap in reporting industry-sponsored clinical research: a joint journal and pharmaceutical industry perspective. Mayo Clin Proc. 2012;87:424–9. doi:10.1016/j.mayocp.2012.02.009.PubMedCrossRefGoogle Scholar
  109. 109.
    GlaxoSmithKline (2013) GSK announces further initiatives to advance openness and collaboration to help tackle global health challenges. http://www.gsk.com/media/press-releases/2012/GSK-announces-further-initiatives-to-tackle-global-health-challenges.html.
  110. 110.
    GlaxoSmithKline (2013) GSK announces support for AllTrials campaign for clinical data transparency. http://www.gsk.com/media/press-releases/2013/GSK-announces-support-forAll-Trials-campaign-for-clinical-data-transparency.html.
  111. 111.
    Kmietowicz Z. Roche says it will not relinquish control over access to clinical trial data. BMJ. 2013;346.Google Scholar
  112. 112.
    Asamoah AK, Sharfstein JM. Transparency at the Food and Drug Administration. N Engl J Med. 2010:362(25):2341-3;. doi:10.1056/NEJMp1005202.PubMedGoogle Scholar
  113. 113.
    Melander H, Salmonson T, Abadie E, van Zwieten-Boot B. A regulatory Apologia—a review of placebo-controlled studies in regulatory submissions of new-generation antidepressants. Eur Neuropsychopharmacol. 2008;18:623–7. doi:10.1016/j.euroneuro.2008.06.003.PubMedCrossRefGoogle Scholar
  114. 114.
    Henkel V, Seemüller F, Obermeier M, Adli M, Bauer M, et al. Relationship between baseline severity of depression and antidepressant treatment outcome. Pharmacopsychiatry. 2011;44:27–32. doi:10.1055/s-0030-1267177.PubMedCrossRefGoogle Scholar
  115. 115.
    Henkel V, Casaulta F, Seemüller F, Krähenbühl S, Obermeier M, et al. Study design features affecting outcome in antidepressant trials. J Affect Disord. 2012;141:160–7. doi:10.1016/j.jad.2012.03.021.PubMedCrossRefGoogle Scholar
  116. 116.
    Gøtzsche PC, Jørgensen AW. Opening up data at the European Medicines Agency. BMJ. 2011;342:d2686.PubMedCrossRefGoogle Scholar
  117. 117.
    Eichler H-G, Abadie E, Breckenridge A, Leufkens H, Rasi G. Open clinical trial data for all? A view from regulators. PLoS Med. 2012;9:e1001202. doi:10.1371/journal.pmed.1001202.PubMedCentralPubMedCrossRefGoogle Scholar
  118. 118.
    European Medicines Agency EMEA. Workshop on access to clinical-trial data and transparency kicks off process towards proactive publication of data. emeaeuropaeu. 2012. http://www.emea.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/11/news_detail_001662.jsp&mid=WC0b01ac058004d5c1. accessed 28 Nov 2012.
  119. 119.
    Wieseler B, McGauran N, Kerekes MF, Kaiser T. Access to regulatory data from the European Medicines Agency: the times they are a-changing. Syst Rev. 2012;1:50. doi:10.1136/bmj.329.7477.1253.PubMedCentralPubMedCrossRefGoogle Scholar
  120. 120.
    International Committee of Journal Editors ICMJE. Obligation to publish negative studies. http://www.icmje.org/publishing_1negative.html. Accessed on 10 April 2013.
  121. 121.
    Joober R, Schmitz N, Annable L, Boksa P. Publication bias: what are the challenges and can they be overcome? J Psychiatry Neurosci. 2012;37:149–52. doi:10.1503/jpn.120065.PubMedCentralPubMedCrossRefGoogle Scholar
  122. 122.
    Sridharan L, Greenland P. Editorial policies and publication bias: the importance of negative studies. Arch Intern Med. 2009;169:1022–3. doi:10.1001/archinternmed.2009.100.PubMedCrossRefGoogle Scholar
  123. 123.
    Mirkin JN, Bach PB. Outcome-blinded peer review. Arch Intern Med. 2011;171:1213–4 (author reply 1214). doi:10.1001/archinternmed.2011.56.Google Scholar
  124. 124.
    Colom F, Vieta E. The need for publishing the silent evidence from negative trials. Acta Psychiatr Scand. 2011;123:91–4.PubMedCrossRefGoogle Scholar
  125. 125.
    Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.PubMedCentralPubMedCrossRefGoogle Scholar
  126. 126.
    Kirkham JJ, Dwan KM, Altman DG, Gamble C, Dodd S, et al. The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews. BMJ. 2010;340:c365.PubMedCrossRefGoogle Scholar
  127. 127.
    Senn S. Misunderstanding publication bias: editors are not blameless after all. F1000 Res. 2012. doi:10.3410/f1000research.1-59.v1.
  128. 128.
    Ioannidis JPA. Why most published research findings are false. PLoS Med. 2005;2:e124. doi:10.1371/journal.pmed.0020124.PubMedCentralPubMedCrossRefGoogle Scholar
  129. 129.
    Mathieu S, Chan A-W, Ravaud P. Use of trial register information during the peer review process. PLoS ONE. 2013;8:e59910. doi:10.1371/journal.pone.0059910. http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0059910.

Copyright information

© Springer International Publishing Switzerland (outside the USA) 2013

Authors and Affiliations

  1. 1.Behavioral Health and Neurosciences DivisionPortland Veterans Affairs Medical CenterPortlandUSA
  2. 2.Department of PsychiatryOregon Health and Science University (OHSU)PortlandUSA
  3. 3.Department of PharmacologyOregon Health and Science University (OHSU)PortlandUSA
  4. 4.Center for Ethics in Health Care, OHSUPortlandUSA

Personalised recommendations