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Are results from pharmaceutical-company-sponsored studies available to the public?

European Journal of Clinical Pharmacology Aims and scope Submit manuscript

An Erratum to this article was published on 12 April 2011

Abstract

Purpose

Only 53% and 63% of studies and clinical trials results presented at congresses are published. Company-sponsored trial results are being posted on publicly accessible Web sites. We analyzed the public availability (publication or posting on a Web site) rate, time to publication, and factors predicting public availability of results of studies sponsored by a pharmaceutical company.

Methods

This was a retrospective cohort study analyzing all studies conducted by GlaxoSmithKline in Spain between 2001 and 2006. Initiation and completion were defined as first participant/first visit and last participant/last visit (or their equivalents). Papers published up to 31 March 2009 were considered. Logistic regression models were used to identify factors predicting public availability of results.

Results

The cohort comprised 143 studies (94 clinical trials; of these, 87 were included in international products clinical development plans). Public availability rate was 80% (114/143) for all studies and 78% (73/94) for clinical trials; publication rates were 68% and 61%, respectively. The median time to publication for all studies and trials was 27.3 and 28.4 months, respectively. Study associated to a cancelled project was the only significant factor associated with lower publication rate for all studies [odds ratio (OR) 0.069; 95% confidence interval (CI) 0.02–024; p < 0.001) and trials (OR 0.075; 95% CI 0.016–0.343; p = 0.001) and a lower public availability rate (OR 0.052; 95% CI 0.007–0.382; p = 0.004) for trial results. Therapy area, sample size, positive trial results, duration of experimental phase, and being a clinical trial did not predict publication or public availability.

Conclusions

Eighty percent of studies included in this analysis are publicly available. Web site posting increases public availability rate of clinical trial results from 61% to 78%. Cancellation of projects is the single factor negatively influencing publication and public availability rates.

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Abbreviations

REC:

Research Ethics Committee

GSK:

GlaxoSmithKline

CSR:

Clinical study register

CI:

Confidence interval

References

  1. Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan A-W et al (2008) Systematic Review of the empirical evidence of study publication bias and outcome reporting bias. PLoS ONE 3(8):e3081. doi:10.1371/journal.pone.0003081

    Article  PubMed  Google Scholar 

  2. Easterbrook PJ, Berlin JA, Gopalan R, Matthews DR (1991) Publication bias in clinical research. Lancet 337:867–872

    Article  PubMed  CAS  Google Scholar 

  3. Dickersin K (1990) The existence of publication bias and risk factors for its occurrence. JAMA 263:1385–1389

    Article  PubMed  CAS  Google Scholar 

  4. Stern JM, Simes RJ (1997) Publication bias: evidence of delayed publication in a cohort study of clinical research projects. BMJ 315:640–645

    PubMed  CAS  Google Scholar 

  5. Ioannidis JP (1998) Effect of the statistical significance of results on the time to completion and publication of randomized efficacy trials. JAMA 279:281–286

    Article  PubMed  CAS  Google Scholar 

  6. Callaham ML, Wears RL, Weber E, Barton C, Young G (1998) Positive-outcome bias and other limitations in the outcome of research abstracts submitted to a scientific meeting. JAMA 280:254–257

    Article  PubMed  CAS  Google Scholar 

  7. Krzyzanowska M, Pintilie M, Tannock IF (2003) Factors associated with failure to publish large randomized trials presented at an oncology meeting. JAMA 290:495–501

    Article  PubMed  Google Scholar 

  8. Decullier E, Lheritier V, Chapuis F (2005) Fate of biomedical research protocols and publication bias in France: retrospective cohort study. BMJ 331(7507):19, Epub 2005 Jun 20

    Article  PubMed  Google Scholar 

  9. Scherer RW, Lengenberg P, von Elm E (2007) Full publication of results initially presented in abstracts. Cochrane Database of Systematic Reviews Issue 2, Art No: MR000005. doi:10.1002/14651858.MR000005.pub3

  10. Lee K, Bacchetti P, Sim I (2008) Publication of clinical trials supporting successful new drug applications: a literature analysis. PLoS Med 5(9):e191. doi:10.1371/journal.pmed.0050191

    Article  PubMed  Google Scholar 

  11. Rising K, Bacchetti P, Bero L (2008) Reporting bias in drug trials submitted to the Food and Drug Administration: a review of publication and presentation. PLoS Med 5(11):e217. doi:10.1371/journal.pmed.0050217

    Article  PubMed  Google Scholar 

  12. Klassen TP, Wiebe N, Russell K, Stevens K, Hartling L et al (2002) Abstracts of randomized controlled trials presented at the society for pediatric reaserach meeting. Arch Pediatr Adolesc Med 156:474–479

    PubMed  Google Scholar 

  13. Hall R, Antueno C, Webber A (2007) Publication bias in the medical literature: a review by a Canadian research ethics board. Can J Anesth 54:331–335

    Article  Google Scholar 

  14. Food and Drug Administration Amendments Act 2007. www.fda.gov/oc/initiatives/HR3580.pdf (accessed January 7th, 2009)

  15. Sanossian N, Ohanian AG, Saver JL, Kim LI, Ovbiagele B (2006) Frequency and determinants of nonpublication of research in the stroke literature. Stroke 37:2588–2592

    Article  PubMed  Google Scholar 

  16. Montané E, Vidal X (2007) Fate of the abstracts presented at three Spanish clinical pharmacology congresses and reasons for unpublished research. Eur J Clin Pharmacol 63:103–111

    Article  PubMed  Google Scholar 

  17. Sanders DS, Carter MJ, Hurlstone DP, Lobo AJ, Hoggard N (2001) Research outcomes in British gastroenterology: an audit of the subsequent full publication of abstracts presented at the British Society of Gastroenterology. Gut 49:154–155

    Article  PubMed  CAS  Google Scholar 

  18. Carroll AE, Sox CM, Tarini BA, Ringold S, Christakis DA (2003) Does presentation format at the Pediatric Academic Societies annual meeting predict subsequent publication? Pediatrics 112:1238–1241

    Article  PubMed  Google Scholar 

  19. Pich J, Carne X, Arnaiz JA, Gomez B, Trilla A et al (2003) Role of a research ethics committee in follow-up and publications of results. Lancet 361:1015–1016

    Article  PubMed  Google Scholar 

  20. Turer A, Mahaffey KW, Compton KL, Califf RM, Schulman KA (2007) Publication or presentation of results from multicenter clinical trials: evidence from an academic medical centre. Am Heart J 153:674–680

    Article  PubMed  Google Scholar 

  21. Blümle A, Antes G, Schumacher M, Just H, von Elm E (2008) Clinical research projects at a German medical faculty: follow-up from ethical approval to publication and citation by others. J Med Ethics Sep 34(9):e20

    Article  Google Scholar 

  22. Von Elm E, Röllin A, Blümle A, Huwiler K, Witschi M et al (2008) Publication and non-publication of clinical trials: longitudinal study of applications submitted to a research ethics committee. Swiss Med Wkly 138:197–203

    Google Scholar 

  23. Melander H, Ahlquist-Rastad J, Meijer G, Beermann B (2003) Evidence b(i)ased medicine_ selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. BMJ 326:1171–1173

    Article  PubMed  Google Scholar 

  24. McLennan M, Leong FC, Steele A, Harris J (2008) The influence of industry sponsorship on the acceptance of abstracts and their publication. Am J Obstet Gynecol 198(579):e1-579–e1-4

    Google Scholar 

  25. Decullier E, Chan AW, Chapuis F (2009) Inadequate dissemination of phase I trials: a retrospective cohort study. PLoS Med 6(2):e1000034. doi:10.1371/journal.pmed.1000034

    Article  PubMed  Google Scholar 

  26. Ross JS, Mulvey GK, Hines EM, Nissen SE, Krumholz HM (2009) Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis. PLoS Med 6(9):e1000144. doi:10.1371/journal.pmed.1000144

    Article  PubMed  Google Scholar 

  27. Krall RL, Rockhold F (2006) Reasons for optimism not disillusionment. J Roy Soc Med 99:435

    Article  PubMed  Google Scholar 

  28. Hopewell S, Loudon K, Clarke MJ, Oxman AD, Dickersin K (2009) Publication bias in clinical trials due to statistical significance or direction of trials results. Cochrane Database Syst Rev 21(1):MR000006

    Google Scholar 

  29. Tricco AC, Brehaut J, Chen MH, Moher D (2008) Following 411 Cochrane protocols to completion: a retrospective cohort study. PLoS ONE 3(11):e3684. doi:10.1371/journal.pone.0003684

    Article  PubMed  Google Scholar 

  30. Moher D, Tetzlaff J, Tricco AC, Sampson M, Altman DG (2007) Epidemiology and reporting characteristics of systematic reviews. PLoS Med 4(3):e78. doi:10.1371/journal.pmed.0040078

    Article  PubMed  Google Scholar 

  31. Ünalp A, Tonascia S, Meinert CL (2007) Presentation in relation to publication of results from clinical trials. Contem Clin Trials 28:358–369

    Article  Google Scholar 

  32. Chan A-W (2008) Bias, spin, and misreporting: time for full access to trial protocols and results. PLoS Med 5(11):e230. doi:10.1371/journal.pmed.0050230

    Article  PubMed  Google Scholar 

  33. Hopewell S, ClarkeMJ, Stewart L, Tierney J (2007) Time to publication for results of clinical trials. Cochrane Database of Systematic Reviews Issue 2. Art. No.: MR000011. doi: 10.1002/14651858.MR000011.pub2

  34. Wood AJJ (2009) Progress and deficiencies in the registration of clinical trials. N Engl J Med 360:824–830

    Article  PubMed  CAS  Google Scholar 

  35. Ghersi D, Clarke M, Berlin J, Gülmezoglu AM, Kush T et al (2008) Reporting the findings of clinical trials: a discussion paper. Bull WHO 86:492–493

    PubMed  CAS  Google Scholar 

  36. World Medical Association (2008) Declaration of Helsinki. Ethical principles for medical research involving human subjects. 59th WMA General Assembly, Seoul, October. http://www.wma.net/e/policy/b3.htm (accessed May, 3rd, 2009)

  37. Strahlman E, Rockhold F, Freeman A (2009) Public disclosure of research. Lancet 373:1319–1320

    Article  PubMed  Google Scholar 

  38. Karlberg JPE (2008) Industry clinical testing of new medicinal products requires 95000 study sites and 1300000 subjects annually. Clinical Trial Magnifier 1: 101-19 ( www.ClinicalTrialMagnifier.com)

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Acknowledgements

We thank Dolores Asenjo, Teresa Compañy, Arturo Fueyo, Pilar García Corbeira, José Emilio Martín, Elena Morejón, Felipe Rodríguez-Alcántara, and Josefa Samper for data collection, and Pilar Vicente for providing the impact factor of all manuscripts. We also thank Drs. A. Benbow (London, UK) and X. Carne (Barcelona, Spain) for their critical reading and suggestions on the manuscript.

Financial disclosure

This study required no funding.

Competing interests

At the time of conducting the analysis all authors were GlaxoSmithKline SA employees and own stock in GSK.

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Correspondence to Rafael Dal-Ré.

Additional information

An erratum to this article can be found at http://dx.doi.org/10.1007/s00228-011-1044-1

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Dal-Ré, R., Pedromingo, A., García-Losa, M. et al. Are results from pharmaceutical-company-sponsored studies available to the public?. Eur J Clin Pharmacol 66, 1081–1089 (2010). https://doi.org/10.1007/s00228-010-0898-y

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