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Volumn 116, Issue 1, 2015, Pages 43-53

Clinical trial transparency: Many gains but access to evidence for new medicines remains imperfect

Author keywords

clinical trial data transparency; European Medicines Agency; Food and Drug Administration; pharmaceutical regulation

Indexed keywords

ACCESS TO INFORMATION; ARTICLE; CLINICAL TRIAL (TOPIC); CONFIDENTIALITY; DRUG INDUSTRY; EUROPE; EUROPEAN MEDICINES AGENCY; FOOD AND DRUG ADMINISTRATION; HUMAN; INFORMATION; INTERPERSONAL COMMUNICATION; MEDICAL RESEARCH; MEDICINE; PRIORITY JOURNAL; REGISTRATION; DRUG THERAPY; EVIDENCE BASED MEDICINE; INFORMATION DISSEMINATION; PROCEDURES; PUBLISHING; STANDARDS; TRENDS;

EID: 84950274688     PISSN: 00071420     EISSN: 14718391     Source Type: Journal    
DOI: 10.1093/bmb/ldv042     Document Type: Article
Times cited : (11)

References (67)
  • 1
    • 72849132173 scopus 로고    scopus 로고
    • Dissemination and publication of research findings: An updated review of related biases
    • Song F, Parekh S, Hooper L, et al. Dissemination and publication of research findings: an updated review of related biases. Health Technol Assess 2010;14:1-193.
    • (2010) Health Technol Assess , vol.14 , pp. 1-193
    • Song, F.1    Parekh, S.2    Hooper, L.3
  • 2
    • 81855169543 scopus 로고    scopus 로고
    • Emergency hospitalizations for adverse drug events in older americans
    • Budnitz D, Lovegrove M, Shehab N, et al. Emergency hospitalizations for adverse drug events in older Americans. N Engl J Med 2011;365:2002-12.
    • (2011) N Engl J Med , vol.365 , pp. 2002-2012
    • Budnitz, D.1    Lovegrove, M.2    Shehab, N.3
  • 4
    • 13444263619 scopus 로고    scopus 로고
    • Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and nonselective non-steroidal anti-inflammatory drugs: Nested case-control study
    • Graham D, Campen D, Hui R, et al. Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and nonselective non-steroidal anti-inflammatory drugs: nested case-control study. Lancet 2005;365:475-81.
    • (2005) Lancet , vol.365 , pp. 475-481
    • Graham, D.1    Campen, D.2    Hui, R.3
  • 5
    • 2542447680 scopus 로고    scopus 로고
    • Gastrointestinal bleeding after the introduction of COX-2 inhibitors: Ecological study
    • Mamdani M, Juurlink D, Kopp A, et al. Gastrointestinal bleeding after the introduction of COX-2 inhibitors: ecological study. BMJ 2004;328:1415-6.
    • (2004) BMJ , vol.328 , pp. 1415-1416
    • Mamdani, M.1    Juurlink, D.2    Kopp, A.3
  • 6
    • 9944262983 scopus 로고    scopus 로고
    • Risk of cardiovascular events and rofecoxib: Cumulative meta-analysis
    • Juni P, Nartey L, Reichenbach S, et al. Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. Lancet 2004;364:2021-9.
    • (2004) Lancet , vol.364 , pp. 2021-2029
    • Juni, P.1    Nartey, L.2    Reichenbach, S.3
  • 7
    • 56749166123 scopus 로고    scopus 로고
    • Reporting bias in drug trials submitted to the food and drug administration: Review of publication and presentation
    • 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.
    • (2008) PLoS Med , vol.5 , pp. e217
    • Rising, K.1    Bacchetti, P.2    Bero, L.3
  • 8
    • 38349049478 scopus 로고    scopus 로고
    • Selective publication of antidepressant trials and its influence on apparent efficacy
    • Turner EH, Matthews AM, Linardatos E, et al. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med 2008;358:252-60.
    • (2008) N Engl J Med , vol.358 , pp. 252-260
    • Turner, E.H.1    Matthews, A.M.2    Linardatos, E.3
  • 9
    • 1442311131 scopus 로고    scopus 로고
    • Facing the evidence: Antidepressant treatment in children and adolescents
    • Garland EJ. Facing the evidence: antidepressant treatment in children and adolescents. CMAJ 2004;170:489-91.
    • (2004) CMAJ , vol.170 , pp. 489-491
    • Garland, E.J.1
  • 10
    • 1942445850 scopus 로고    scopus 로고
    • Drug company experts advised staff to withhold data about SSRI use in children
    • Kondro W, Sibbald B. Drug company experts advised staff to withhold data about SSRI use in children. CMAJ 2004;170:783.
    • (2004) CMAJ , vol.170 , pp. 783
    • Kondro, W.1    Sibbald, B.2
  • 11
    • 0034961468 scopus 로고    scopus 로고
    • Efficacy of paroxetine in the treatment of adolescent major depression: A randomized, controlled trial
    • Keller MB, Ryan ND, Strober M, 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.
    • (2001) J Am Acad Child Adolesc Psychiatry , vol.40 , pp. 762-772
    • Keller, M.B.1    Ryan, N.D.2    Strober, M.3
  • 12
    • 84950235914 scopus 로고    scopus 로고
    • Report disputes benefit of stockpiling tamiflu
    • (1 October 2015, date last accessed)
    • Van Noorden R. Report disputes benefit of stockpiling Tamiflu. Nature 2014. doi:10.1038/nature.2014.15022. Available at: http://www.nature.com/news/report-disputesbenefit-of-stockpiling-tamiflu-1.15022 (1 October 2015, date last accessed).
    • (2014) Nature
    • Van Noorden, R.1
  • 13
    • 84865159167 scopus 로고    scopus 로고
    • Neuraminidase inhibitors for preventing and treating influenza in healthy adults and children
    • Jefferson T, Jones MA, Doshi P, et al. Neuraminidase inhibitors for preventing and treating influenza in healthy adults and children. Cochrane Database Syst Rev 2012;1:CD008965.
    • (2012) Cochrane Database Syst Rev , vol.1 , pp. CD008965
    • Jefferson, T.1    Jones, M.A.2    Doshi, P.3
  • 14
    • 0042259159 scopus 로고    scopus 로고
    • Impact of oseltamivir treatment on influenza-related lower respiratory tract complications and hospitalizations
    • Kaiser L, Wat C, Mills T, et al. Impact of oseltamivir treatment on influenza-related lower respiratory tract complications and hospitalizations. Arch Intern Med 2003;163:1667-72.
    • (2003) Arch Intern Med , vol.163 , pp. 1667-1672
    • Kaiser, L.1    Wat, C.2    Mills, T.3
  • 15
    • 84930817195 scopus 로고    scopus 로고
    • Compliance with results reporting at clinical trials.gov
    • Anderson ML, Chiswell K, Peterson ED, et al. Compliance with results reporting at Clinical Trials.gov. N Engl J Med 2015;372:1031-9.
    • (2015) N Engl J Med , vol.372 , pp. 1031-1039
    • Anderson, M.L.1    Chiswell, K.2    Peterson, E.D.3
  • 16
    • 84886614481 scopus 로고    scopus 로고
    • Completeness of reporting of patient-relevant clinical trial outcomes: Comparison of unpublished clinical study reports with publicly available data
    • Wieseler B, Wolfram N, McGauran N, et al. Completeness of reporting of patient-relevant clinical trial outcomes: comparison of unpublished clinical study reports with publicly available data. PLoSMed 2013;10:e1001526.
    • (2013) PLoSMed , vol.10 , pp. e1001526
    • Wieseler, B.1    Wolfram, N.2    McGauran, N.3
  • 17
    • 84857127828 scopus 로고    scopus 로고
    • Impact of document type on reporting quality of clinical drug trials: A comparison of registry reports, clinical study reports, and journal publications
    • Wieseler B, Kerekes MF, Vervoelgyi V, et al. Impact of document type on reporting quality of clinical drug trials: a comparison of registry reports, clinical study reports, and journal publications. BMJ 2011;344:d8141.
    • (2011) BMJ , vol.344 , pp. d8141
    • Wieseler, B.1    Kerekes, M.F.2    Vervoelgyi, V.3
  • 18
    • 84888189952 scopus 로고    scopus 로고
    • Nonpublication of large randomized clinical trials: Cross sectional analysis
    • Jones CW, Handler L, Crowell KE, et al. Nonpublication of large randomized clinical trials: cross sectional analysis. BMJ 2013;347:f6104.
    • (2013) BMJ , vol.347 , pp. f6104
    • Jones, C.W.1    Handler, L.2    Crowell, K.E.3
  • 19
    • 84858996695 scopus 로고    scopus 로고
    • Effect of reporting bias on meta-analyses of drug trials: Reanalysis of meta-analyses
    • Hart B, Lundh A, Bero L. Effect of reporting bias on meta-analyses of drug trials: reanalysis of meta-analyses. BMJ 2012;344:d7202.
    • (2012) BMJ , vol.344 , pp. d7202
    • Hart, B.1    Lundh, A.2    Bero, L.3
  • 20
    • 85006298144 scopus 로고    scopus 로고
    • Regulatory agencies hold the key to improving cochrane reviews of drugs
    • Schroll JB, Bero L. Regulatory agencies hold the key to improving Cochrane reviews of drugs. Cochrane Database Syst Rev 2015;4:ED000098.
    • (2015) Cochrane Database Syst Rev , vol.4 , pp. ED000098
    • Schroll, J.B.1    Bero, L.2
  • 21
    • 84925768154 scopus 로고    scopus 로고
    • Information on new drugs at market entry: Retrospective analysis of health technology assessment reports versus regulatory reports, journal publications, and registry reports
    • Kohler M, Haag S, Biester K, 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 2015;350: h796.
    • (2015) BMJ , vol.350 , pp. h796
    • Kohler, M.1    Haag, S.2    Biester, K.3
  • 22
    • 84924238524 scopus 로고    scopus 로고
    • Quality and quantity of information in summary basis of decision documents issued by health Canada
    • Habibi R, Lexchin J. Quality and quantity of information in summary basis of decision documents issued by health Canada. PLoS One 2014;9:e92038.
    • (2014) PLoS One , vol.9 , pp. e92038
    • Habibi, R.1    Lexchin, J.2
  • 23
    • 84936822892 scopus 로고    scopus 로고
    • Comparison of content of FDA letters not approving applications for new drugs and associated public announcements from sponsors: Cross-sectional study
    • Lurie P, Chahal H, Sigelman D, et al. Comparison of content of FDA letters not approving applications for new drugs and associated public announcements from sponsors: cross-sectional study. BMJ 2015;350:h2758.
    • (2015) BMJ , vol.350 , pp. h2758
    • Lurie, P.1    Chahal, H.2    Sigelman, D.3
  • 24
    • 84926288672 scopus 로고    scopus 로고
    • Accessibility of trial reports for drugs stalling in development: A systematic assessment of registered trials
    • Hakala A, Kimmelman J, Carlisle B, et al. Accessibility of trial reports for drugs stalling in development: a systematic assessment of registered trials. BMJ 2015;350: h1116.
    • (2015) BMJ , vol.350 , pp. h1116
    • Hakala, A.1    Kimmelman, J.2    Carlisle, B.3
  • 25
    • 77958142340 scopus 로고    scopus 로고
    • Reboxetine for acute treatment of major depression: Systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials
    • Eyding D, Lelgemann M, Grouven U, 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.
    • (2010) BMJ , vol.341 , pp. c4737
    • Eyding, D.1    Lelgemann, M.2    Grouven, U.3
  • 26
    • 84893909238 scopus 로고    scopus 로고
    • Neuraminidase inhibitors for preventing and treating influenza in adults and children
    • Jefferson T, Jones M, Doshi P, et al. Neuraminidase inhibitors for preventing and treating influenza in adults and children. Cochrane Database Syst Rev 2014; DOI: 10.1002/14651858.CD008965.pub4.
    • (2014) Cochrane Database Syst Rev
    • Jefferson, T.1    Jones, M.2    Doshi, P.3
  • 27
    • 84886251445 scopus 로고    scopus 로고
    • (1 October 2015, date last accessed)
    • Pharmaceutical Research and Manufacturers of America, European Federation of Pharmaceutical Industries and Associations. Principles for responsible clinical trial data sharing: our commitment to patients and researchers. 2013. Available at: http://www.phrma.org/sites/default/files/pdf/PhRMAPrinciplesForResponsibleClinicalTrialDataSharing.pdf (1 October 2015, date last accessed).
    • (2013) Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers
  • 29
    • 84950265508 scopus 로고    scopus 로고
    • EMA's proposed data release policy: Promoting transparency or expanding pharma control over data?
    • (1 October 2015, date last accessed)
    • Lemmens T. EMA's proposed data release policy: promoting transparency or expanding pharma control over data? PLoS Blogs, 2014. Available at: http://blogs.plos.org/speakingofmedicine/2014/05/30/emas-new-data-releasepolicy-promoting-transparency-expanding-pharma-controldata/ (1 October 2015, date last accessed).
    • (2014) PLoS Blogs
    • Lemmens, T.1
  • 32
    • 1442360089 scopus 로고    scopus 로고
    • Randomized clinical trials: Why gets published, and when?
    • Hirsch L. Randomized clinical trials: why gets published, and when? CMAJ 2004;170:481-3.
    • (2004) CMAJ , vol.170 , pp. 481-483
    • Hirsch, L.1
  • 35
    • 84904262560 scopus 로고    scopus 로고
    • Differences in reporting serious adverse events in industry sponsored clinical trial registries and journal articles on antidepressant and antipsychotic drugs: A cross-sectional study
    • Hughes S, Cohen D, 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 2014;4:e005535.
    • (2014) BMJ Open , vol.4 , pp. e005535
    • Hughes, S.1    Cohen, D.2    Jaggi, R.3
  • 36
    • 84880893300 scopus 로고    scopus 로고
    • Access to patient-level data from GlaxoSmithKline clinical trials
    • Nisen P, Rockhold F. Access to patient-level data from GlaxoSmithKline clinical trials. N Engl J Med 2013; 369:475-8.
    • (2013) N Engl J Med , vol.369 , pp. 475-478
    • Nisen, P.1    Rockhold, F.2
  • 37
    • 84898410249 scopus 로고    scopus 로고
    • Give the data to the people
    • (1 October 2015, date last accessed)
    • Krumholz H. Give the data to the people. New York Times, 2014. Available at: http://www.nytimes.com/2014/02/03/opinion/give-the-data-to-the-people.html?-r=0 (1 October 2015, date last accessed).
    • (2014) New York Times
    • Krumholz, H.1
  • 40
    • 84915821852 scopus 로고    scopus 로고
    • Data sharing, year 1-access to data from industry-sponsored clinical trials
    • Strom B, Buyse M, Hughes J, et al. Data sharing, year 1-access to data from industry-sponsored clinical trials. N Engl J Med 2014;371:2052-4.
    • (2014) N Engl J Med , vol.371 , pp. 2052-2054
    • Strom, B.1    Buyse, M.2    Hughes, J.3
  • 41
    • 84957432342 scopus 로고    scopus 로고
    • About this site. (1 October 2015, date last accessed)
    • ClinicalStudy Data Request.com, About this site. 2015. Available at: https://clinicalstudydatarequest.com (1 October 2015, date last accessed).
    • (2015) ClinicalStudy Data Request.com
  • 42
    • 84950299520 scopus 로고    scopus 로고
    • (1 October 2015, date last accessed)
    • Metrics: Clinical Study Data Request.com, 2015. Available at: https://clinicalstudydatarequest.com/Metrics.aspx (1 October 2015, date last accessed).
    • (2015) Metrics: Clinical Study Data Request.com
  • 43
    • 84878238262 scopus 로고    scopus 로고
    • Roche says it will not relinquish control over access to clinical trial data
    • Kmietowicz Z. Roche says it will not relinquish control over access to clinical trial data. BMJ 2013;346:f1374.
    • (2013) BMJ , vol.346 , pp. f1374
    • Kmietowicz, Z.1
  • 47
    • 84920053885 scopus 로고    scopus 로고
    • Transparency and the european medicines agency-sharing of clinical trial data
    • Bonini S, Eichler H-G, Wathion N, et al. Transparency and the European Medicines Agency-sharing of clinical trial data. N Engl J Med 2014;371:2452-5.
    • (2014) N Engl J Med , vol.371 , pp. 2452-2455
    • Bonini, S.1    Eichler, H.-G.2    Wathion, N.3
  • 48
    • 84886314764 scopus 로고    scopus 로고
    • Access to patientlevel trial data-A boon to drug developers
    • Eichler H-G, Pétavy F, Pignatti F, et al. Access to patientlevel trial data-a boon to drug developers. N Engl J Med 2013;369:1577-9.
    • (2013) N Engl J Med , vol.369 , pp. 1577-1579
    • Eichler, H.-G.1    Pétavy, F.2    Pignatti, F.3
  • 49
    • 84893101724 scopus 로고    scopus 로고
    • Access to patient-level trial data
    • Barron H, Rosenblatt M. Access to patient-level trial data. N Engl J Med 2014;370:485-6.
    • (2014) N Engl J Med , vol.370 , pp. 485-486
    • Barron, H.1    Rosenblatt, M.2
  • 51
    • 84924371285 scopus 로고    scopus 로고
    • Complaints, complainants, and rulings regarding drug promotion in the United Kingdom and Sweden 2004-2012: A quantitative and qualitative study of pharmaceutical industry selfregulation
    • Zetterqvist A, Merlo J, Mulinari S. Complaints, complainants, and rulings regarding drug promotion in the United Kingdom and Sweden 2004-2012: a quantitative and qualitative study of pharmaceutical industry selfregulation. PLoS Med 2015;12:e1001785.
    • (2015) PLoS Med , vol.12 , pp. e1001785
    • Zetterqvist, A.1    Merlo, J.2    Mulinari, S.3
  • 53
    • 84950302460 scopus 로고    scopus 로고
    • (1 October, date last accessed)
    • European Federation of Pharmaceutical Industries and Associations. EFPIA response to EMA consultation on the publication and access to clinical-trial data, 2013. Available at: http://www.efpia.eu/mediaroom/118/44/EFPIA-Response-to-EMA-Consultation-on-the-Publicationand-Access-to-Clinical-Trial-Data (1 October 2015, date last accessed).
    • (2015) EFPIA Response to EMA Consultation on the Publication and Access to Clinical-trial Data, 2013
  • 54
    • 84886256948 scopus 로고    scopus 로고
    • Preparing for responsible sharing of clinical trial data
    • Mello M, Francer J, Wilenzick M, et al. Preparing for responsible sharing of clinical trial data. N Engl J Med 2013;369:1651-7.
    • (2013) N Engl J Med , vol.369 , pp. 1651-1657
    • Mello, M.1    Francer, J.2    Wilenzick, M.3
  • 55
    • 84876979076 scopus 로고    scopus 로고
    • Pharmaceutical knowledge governance: A human rights perspective
    • Lemmens T. Pharmaceutical knowledge governance: a human rights perspective. J Law Med Ethics 2013;41: 163-84.
    • (2013) J Law Med Ethics , vol.41 , pp. 163-184
    • Lemmens, T.1
  • 56
    • 76949086699 scopus 로고    scopus 로고
    • US National Institutes of Health
    • Clinical Trials.gov: US National Institutes of Health, 2015.
    • (2015) Clinical Trials.gov
  • 57
    • 84950245507 scopus 로고    scopus 로고
    • London: Sense About Science
    • AllTrials. London: Sense About Science, 2014.
    • (2014) AllTrials
  • 59
    • 84930532926 scopus 로고    scopus 로고
    • How to get all trials reported: Audit, better data, and individual accountability
    • Goldacre B. How to get all trials reported: audit, better data, and individual accountability. PLoS Med 2015;12: e1001821.
    • (2015) PLoS Med , vol.12 , pp. e1001821
    • Goldacre, B.1
  • 62
    • 84904878534 scopus 로고    scopus 로고
    • EMA policy on transparency is "strikingly" similar to deal struck with drug company, say experts
    • Doshi P. EMA policy on transparency is "strikingly" similar to deal struck with drug company, say experts. BMJ 2014;348:g3852.
    • (2014) BMJ , vol.348 , pp. g3852
    • Doshi, P.1
  • 66
    • 84930664952 scopus 로고    scopus 로고
    • (1 October 2015, date last accessed)
    • World Health Organization. WHO statement on public disclosure of clinical trial results, 2015. Available at: http://www.who.int/ictrp/results/reporting/en/ (1 October 2015, date last accessed).
    • (2015) WHO Statement on Public Disclosure of Clinical Trial Results
  • 67
    • 84920621681 scopus 로고    scopus 로고
    • Clinical trials registration and results submission; proposed rule
    • Department of Health and Human Services. Clinical trials registration and results submission; proposed rule. Fed Regist 2014;79:69566-680.
    • (2014) Fed Regist , vol.79 , pp. 69566-69680


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