Hostname: page-component-586b7cd67f-r5fsc Total loading time: 0 Render date: 2024-11-22T06:28:25.819Z Has data issue: false hasContentIssue false
  • English
  • Français

Disclose Data Publicly, without Restriction

Published online by Cambridge University Press:  01 January 2021

Peter Doshi  and
Tom Jefferson
Get access Rights & Permissions [Opens in a new window]

Abstract

Ethical, evidence-informed decision making is undermined by the grave concerns that have emerged over the trustworthiness of clinical trials published in biomedical journals. The inescapable conclusion from this growing body of research is that what we see, even in the most highly regarded peer-reviewed journals, cannot be trusted at face value. Concerns of inaccurate, biased, and insufficient reporting of trials are impossible to resolve without access to underlying trial data. Access to such data, including things like clinical study reports—huge, unabridged, detailed reports of clinical trials—would minimise the risk of distortions and selective publication. But the FDA, the world’s greatest custodian of those data, just sits on them. We see no reason why FDA should not publicly release clinical study reports with minimal redactions. The European regulator is already doing this, but FDA’s holdings are far greater. Data transparency is not simply an “opportunity” FDA might consider, but rather an ethical imperative. The Blueprint is good but does not go far enough. We do not need gates, barriers and committees between us and access to aggregate reports on drugs and other interventions which we are prescribing or using daily. Let’s leave the nannies at home.

Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 45 , Issue S2: Symposium - Blueprint for Transparency at the U.S. Food and Drug Administration , Winter 2017 , pp. 42 - 45
Copyright
Copyright © American Society of Law, Medicine and Ethics 2017

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Food and Drug Administration, “Availability of Masked and De-identified Non-Summary Safety and Efficacy Data; Request for Comments (Docket No. FDA-2013-N-0271),” Federal Register 3 (2013); 33421–3343.Google Scholar
FDA Transparency Working Group, Blueprint for Transparency at the U.S. Food and Drug Administration,” Journal of Law, Medicine & Ethics 45, no. 4, Suppl. (2017): 7–23.CrossRefGoogle Scholar
Simes, R. J., “Publication Bias: The Case for an International Registry of Clinical Trials,” Journal of Clinical Oncology 4, no. 10 (1986): 1529–1541; Dickersin, K. and Min, Y. I., “Publication Bias: The Problem That Won’t Go Away,” Annals of the New York Academy of Science 703 (1993): 135–146, at discussion 146-148. The Cochrane Collaboration, ed., Publication Bias in Clinical Trials Due to Statistical Significance or Direction of Trial Results,” in Cochrane Database of Systematic Reviews (Chichester, UK: John Wiley & Sons, Ltd., 1996): at 147 (2nd International Conference Scientific Basis of Health Services & 5th Annual Cochrane Colloquium, October 5-8, 1997, Amsterdam, The Netherlands, vol. 46).CrossRefGoogle Scholar
Higgins, J. P. T., Green, S., eds., Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011), The Cochrane Collaboration, 2011.Google Scholar
Chan, A.-W., Hróbjartsson, A., Haahr, M. T., Gøtzsche, P. C., and Altman, D. G., “Empirical Evidence for Selective Reporting of Outcomes in Randomized Trials: Comparison of Protocols to Published Articles,” JAMA 291, no. 20 (2004): 2457–2465; Coyne, D. W., “The Health-Related Quality of Life Was Not Improved by Targeting Higher Hemoglobin in the Normal Hematocrit Trial,” Kidney International 82, no. 2 (2012): 235–241; Dwan, K., Gamble, C., Williamson, P. R., and Kirkham, J. J., “Reporting Bias Group. Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias: An Updated Review,” PLoS One 8, no. 7 (2013): e66844; Eyding, D., Lelgemann, M., Grouven, U., Härter, M., Kromp, M., Kaiser, T., 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 341 (2010): c4737; Fu, R., Selph, S., McDonagh, M., Peterson, K., Tiwari, A., Chou, R., et al., “Effectiveness and Harms of Recombinant Human Bone Morphogenetic Protein-2 in Spine Fusion: A Systematic Review and Meta-analysis,” Annals of Internal Medicine 158, no. 12 (2013): 890–902; Golder, S., Loke, Y. K., Wright, K., and Norman, G., “Reporting of Adverse Events in Published and Unpublished Studies of Health Care Interventions: A Systematic Review,” PLoS Medicine 13, no. 9 (2016): e1002127; Hughes, S., Cohen, D., and Jaggi, R., “Differences in Reporting Serious Adverse Events in Industry Sponsored Clinical Trial Registries and Journal Articles on Antidepressant and Antipsychotic Drugs: A Cross-Sectional Study,” BMJ Open 4, no. 7 (2014): e005535; Huić, M., Marušić, M., and Marušić, A., “Completeness and Changes in Registered Data and Reporting Bias of Randomized Controlled Trials in ICMJE Journals after Trial Registration Policy,” PLoS One 6, no. 9 (2011): e25258; Jefferson, T., Doshi, P., Thompson, M., and Heneghan, C., “Ensuring Safe and Effective Drugs: Who Can Do What It Takes?” BMJ 342 (2011): c7258; Jefferson, T., Jones, M. A., Doshi, P., Del Mar, C. B., Heneghan, C. J., Hama, R., et al., “Neuraminidase Inhibitors for Preventing and Treating Influenza in Healthy Adults and Children,” Cochrane Database of Systematic Reviews 1 (2012): CD008965; Köhler, M., Haag, S., Biester, K., Brockhaus, A. C., McGauran, N., Grouven, U., et al., “Information on New Drugs at Market Entry: Retrospective Analysis of Health Technology Assessment Reports Versus Regulatory Reports, Journal Publications, and Registry Reports,” BMJ 350 (2015): h796; Le Noury, J., Nardo, J. M., Healy, D., Jureidini, J., Raven, M., Tufanaru, C., et al., “Restoring Study 329: Efficacy and Harms of Paroxetine and Imipramine in Treatment of Major Depression in Adolescence,” BMJ 351 (2015): h4320; Lundh, A., Lexchin, J., Mintzes, B., Schroll, J. B., and Bero, L., “Industry Sponsorship and Research Outcome,” Cochrane Database of Systematic Reviews 2 (2017): MR000033; Maund, E., Tendal, B., Hróbjartsson, A., Jørgensen, K. J., Lundh, A., Schroll, J., et al., “Benefits and Harms in Clinical Trials of Duloxetine for Treatment of Major Depressive Disorder: Comparison of Clinical Study Reports, Trial Registries, and Publications,” BMJ 348 (2014): g3510; McGauran, N., Wieseler, B., Kreis, J., Schüler, Y.-B., Kölsch, H., “Kaiser T. Reporting Bias in Medical Research: A Narrative Review,” Trials 11 (2010): 37; Rodgers, M. A., Brown, J. V. E., Heirs, M. K., Higgins, J. P. T., Mannion, R. J., Simmonds, M. C., et al., “Reporting of Industry Funded Study Outcome Data: Comparison of Confidential and Published Data on the Safety and Effectiveness of rhBMP-2 for Spinal Fusion,” BMJ 346 (2013): f3981; Saini, P., Loke, Y. K., Gamble, C., Altman, D. G., Williamson, P. R., and Kirkham, J. J., “Selective Reporting Bias of Harm Outcomes within Studies: Findings from a Cohort of Systematic Reviews,” BMJ 349 (2014): g6501; Song, F., Parekh, S., Hooper, L., Loke, Y.K., Ryder, J., Sutton, A. J., et al., “Dissemination and Publication of Research Findings: An Updated Review of Related Biases,” Health Technology Assessment 14, no. 8 (2010): iii, ix-xi, 1–193; Turner, E. H., Matthews, A. M., Linardatos, E., Tell, R. A., and Rosenthal, R., “Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy,” New England Journal of Medicine 358, no. 3 (2008): 252–260; Vedula, S. S., Li, T., and 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 Medicine 10, no. 1 (2013): e1001378; Vedula, S. S., Bero, L., Scherer, R. W., and Dickersin, K., “Outcome Reporting in Industry-Sponsored Trials of Gabapentin for Off-Label Use,” New England Journal of Medicine 361, no. 20 (2009): 1963–1971; Wieseler, B., Kerekes, M. F., Vervoelgyi, V., McGauran, N., and Kaiser, T., “Impact of Document Type on Reporting Quality of Clinical Drug Trials: A Comparison of Registry Reports, Clinical Study Reports, and Journal Publications,” BMJ 344 (2012): d8141; Wieseler, B., Wolfram, N., McGauran, N., Kerekes, M. F., Vervölgyi, V., Kohlepp, P., et al., “Completeness of Reporting of Patient-Relevant Clinical Trial Outcomes: Comparison of Unpublished Clinical Study Reports with Publicly Available Data,” PLoS Medicine 10, no. 10 (2013): e1001526; Yank, V., Rennie, D., and Bero, L. A., “Financial Ties and Concordance between Results and Conclusions in Meta-analyses: Retrospective Cohort Study,” BMJ 335, no. 7631 (2007): 1202–1205; Vedula, S. S., Goldman, P. S., Rona, I. J., Greene, T. M., and Dickersin, K., “Implementation of a Publication Strategy in the Context of Reporting Biase: A Case Study Based on New Documents from Neurontin Litigation,” Trials 13 (2012):136.CrossRefGoogle Scholar
Doshi, P. and Jefferson, T., “Clinical Study Reports of Randomised Controlled Trials: An Exploratory Review of Previously Confidential Industry Reports,” BMJ Open 3, no. 2 (2013), available at <http://dx.doi.org/10.1136/bmjopen-2012-002496> (last visited November 8, 2017).CrossRefGoogle Scholar
See Le Noury, et al., supra note 5.Google Scholar
Personal communication with Anne-Sophie Henry-Eude, June 27 and July 24, 2017.Google Scholar
Doshi, P. and Jefferson, T., “Open Data 5 Years On: A Case Series of 12 Freedom of Information Requests for Regulatory Data to the European Medicines Agency,” Trials 17 (2016): 78.CrossRefGoogle Scholar
European Medicines Agency, “Online Access to Clinical Data for Medicinal Products for Human Use,” European Medicines Agency Clinical Data, available at <https://clinicaldata.ema.europa.eu/> (last visited November 8, 2017).+(last+visited+November+8,+2017).>Google Scholar
El Emam, K., Rodgers, S., and Malin, B., “Anonymising and Sharing Individual Patient Data,” BMJ 350 (2015): h1139.CrossRefGoogle Scholar
HHS, DRAFT Pandemic Influenza Preparedness and Response Plan (2004), cited July 5, 2010, available at <http://web.archive.org/web/20041016003906/ http://www.dhhs.gov/nvpo/pandemicplan/finalpandemiccore.pdf> (last visited November 8, 2017); HHS, HHS Pandemic Influenza Plan (2005), cited January 23, 2013, available at <http://www.pandemicflu.gov/planning-preparedness/federal/hhspandemicinfluenzaplan.pdf> (last visited November 8, 2017).+(last+visited+November+8,+2017);+HHS,+HHS+Pandemic+Influenza+Plan+(2005),+cited+January+23,+2013,+available+at++(last+visited+November+8,+2017).>Google Scholar
Kaiser, L., Wat, C., Mills, T., Mahoney, P., Ward, P., and Hayden, F., “Impact of Oseltamivir Treatment on Influenza-Related Lower Respiratory Tract Complications and Hospitalizations,” Archives of Internal Medicine 163, no. 14 (2003): 1667–1672.CrossRefGoogle Scholar
See Jefferson, , et al., supra note 5; Jefferson, T. and Doshi, P., “Multisystem Failure: The Story of Anti-influenza Drugs,” BMJ 348 (2014): g2263.CrossRefGoogle Scholar
Doshi, P. and Godlee, F., “The Wider Role of Regulatory Scientists,” BMJ 357 (2017): j1991.CrossRefGoogle Scholar