Data sharing and reanalysis of randomized controlled trials in leading biomedical journals with a full data sharing policy: Survey of studies published in the BMJ and PLOS Medicine

BMJ (Online)

Volumn 360, Issue , 2018, Pages

  Naudet, Florian ^a   Sakarovitch, Charlotte ^a   Janiaud, Perrine ^a   Cristea, Ioana ^a,b   Fanelli, Daniele ^a,c   Moher, David ^a,d   Ioannidis, John P A ^a,e  

^a STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b BABE BOLYAI UNIVERSITY   (Romania)

^c LONDON SCHOOL OF ECONOMICS   (United Kingdom)

^d OTTAWA HOSPITAL RESEARCH INSTITUTE   (Canada)

^e STANFORD LAW SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACCESS TO INFORMATION; ARTICLE; DATA AVAILABILITY; DATA EXTRACTION; DATA PROCESSING; DATA SHARING; HEALTH CARE POLICY; HUMAN; INFORMATION PROCESSING; MEDICAL INFORMATION; MEDICAL LITERATURE; PRIORITY JOURNAL; PRIVACY; RANDOMIZED CONTROLLED TRIAL (TOPIC); REPRODUCIBILITY; SYSTEMATIC ERROR; INFORMATION DISSEMINATION; MEASUREMENT ACCURACY; PUBLICATION; STATISTICS AND NUMERICAL DATA;

DATA ACCURACY; HUMANS; INFORMATION DISSEMINATION; PERIODICALS AS TOPIC; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 85042159426     PISSN: 09598146     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.k400     Document Type: Article

References (52)

1. Taichman DB, Backus J, Baethge C, et al. Sharing Clinical Trial Data: A Proposal from the International Committee of Medical Journal Editors. PLoS Med 2016;13:e1001950. doi:10.1371/journal.pmed.1001950.
2. Platt R, Ramsberg J. Challenges for Sharing Data from Embedded Research. N Engl J Med 2016;374:1897. doi:10.1056/NEJMc1602016.
3. Kalager M, Adami HO, Bretthauer M. Recognizing Data Generation. N Engl J Med 2016;374:1898. doi:10.1056/NEJMc1603789.
4. Devereaux PJ, Guyatt G, Gerstein H, Connolly S, Yusuf S, International Consortium of Investigators for Fairness in Trial Data Sharing. Toward Fairness in Data Sharing. N Engl J Med 2016;375:405-7. doi:10.1056/NEJMp1605654.
5. Haug CJ. Whose Data Are They Anyway? Can a Patient Perspective Advance the Data-Sharing Debate? N Engl J Med 2017;376:2203-5. doi:10.1056/NEJMp1704485.
6. Rockhold F, Nisen P, Freeman A. Data Sharing at a Crossroads. N Engl J Med 2016;375:1115-7. doi:10.1056/NEJMp1608086.
7. Rosenbaum L. Bridging the Data-Sharing Divide-Seeing the Devil in the Details, Not the Other Camp. N Engl J Med 2017;376:2201-3. doi:10.1056/NEJMp1704482.
8. Taichman DB, Sahni P, Pinborg A, et al. Data sharing statements for clinical trials. BMJ 2017;357:j2372. doi:10.1136/bmj.j2372
9. Godlee F, Groves T. The new BMJ policy on sharing data from drug and device trials. BMJ 2012;345:e7888. doi:10.1136/bmj.e7888
10. Loder E, Groves T. The BMJ requires data sharing on request for all trials. BMJ 2015;350:h2373. doi:10.1136/bmj.h2373
11. Bloom T, Ganley E, Winker M. Data access for the open access literature: PLOS's data policy. PLoS Biol 2014;12:e1001797doi:10.1371/journal. pbio.1001797.
12. Mello MM, Francer JK, Wilenzick M, Teden P, Bierer BE, Barnes M. Preparing for responsible sharing of clinical trial data. N Engl J Med 2013;369:1651-8. doi:10.1056/NEJMhle1309073.
13. Zarin DA, Tse T. Sharing Individual Participant Data (IPD) within the Context of the Trial Reporting System (TRS). PLoS Med 2016;13:e1001946. doi:10.1371/journal.pmed.1001946.
14. Newcombe RG. Two-sided confdence intervals for the single proportion: comparison of seven methods[pii]. Stat Med 1998;17:857-72. doi:10.1002/(SICI)1097-0258(19980430)17: 83.0.CO;2-E.
15. Kidwell MC, Lazarevic LB, Baranski E, et al. Badges to Acknowledge Open Practices: A Simple, Low-Cost, Effective Method for Increasing Transparency. PLoS Biol 2016;14:e1002456. doi:10.1371/journal. pbio.1002456.
16. Adrion C, Fischer CS, Wagner J, Gürkov R, Mansmann U, Strupp M, BEMED Study Group. Efcacy and safety of betahistine treatment in patients with Meniere's disease: primary results of a long term, multicentre, double blind, randomised, placebo controlled, dose defning trial (BEMED trial). BMJ 2016;352:h6816. doi:10.1136/bmj.h6816.
17. Atukunda EC, Siedner MJ, Obua C, Mugyenyi GR, Twagirumukiza M, Agaba AG. Sublingual misoprostol versus intramuscular oxytocin for prevention of postpartum hemorrhage in Uganda: a double-blind randomized non-inferiority trial. PLoS Med 2014;11:e1001752. doi:10.1371/journal.pmed.1001752.
18. Bousema T, Stresman G, Baidjoe AY, et al. The Impact of Hotspot-Targeted Interventions on Malaria Transmission in Rachuonyo South District in the Western Kenyan Highlands: A Cluster-Randomized Controlled Trial. PLoS Med 2016;13:e1001993. doi:10.1371/journal.pmed.1001993.
19. Chesterton LS, Lewis AM, Sim J, et al. Transcutaneous electrical nerve stimulation as adjunct to primary care management for tennis elbow: pragmatic randomised controlled trial (TATE trial). BMJ 2013;347:f5160. doi:10.1136/bmj.f5160.
20. Cohen SP, Hanling S, Bicket MC, et al. Epidural steroid injections compared with gabapentin for lumbosacral radicular pain: multicenter randomized double blind comparative efcacy study. BMJ 2015;350:h1748. doi:10.1136/bmj.h1748.
21. Gysin-Maillart A, Schwab S, Soravia L, Megert M, Michel K. A Novel Brief Therapy for Patients Who Attempt Suicide: A 24-months Follow-Up Randomized Controlled Study of the Attempted Suicide Short Intervention Program (ASSIP). PLoS Med 2016;13:e1001968. doi:10.1371/journal.pmed.1001968.
22. Hanson C, Manzi F, Mkumbo E, et al. Effectiveness of a Home-Based Counselling Strategy on Neonatal Care and Survival: A Cluster-Randomised Trial in Six Districts of Rural Southern Tanzania. PLoS Med 2015;12:e1001881. doi:10.1371/journal.pmed.1001881.
23. Harris T, Kerry SM, Victor CR, et al. A primary care nurse-delivered walking intervention in older adults: PACE (pedometer accelerometer consultation evaluation)-Lif cluster randomised controlled trial. PLoS Med 2015;12:e1001783. doi:10.1371/journal.pmed.1001783.
24. Hyttel-Sorensen S, Pellicer A, Alderliesten T, et al. Cerebral near infrared spectroscopy oximetry in extremely preterm infants: phase II randomised clinical trial. BMJ 2015;350:g7635. doi:10.1136/bmj. g7635.
25. Liu X, Lewis JJ, Zhang H, et al. Effectiveness of Electronic Reminders to Improve Medication Adherence in Tuberculosis Patients: A Cluster-Randomised Trial. PLoS Med 2015;12:e1001876. doi:10.1371/journal.pmed.1001876.
26. Lombard C, Harrison C, Kozica S, Zoungas S, Ranasinha S, Teede H. Preventing Weight Gain in Women in Rural Communities: A Cluster Randomised Controlled Trial. PLoS Med 2016;13:e1001941. doi:10.1371/journal.pmed.1001941.
27. Luedtke K, Rushton A, Wright C, et al. Effectiveness of transcranial direct current stimulation preceding cognitive behavioural management for chronic low back pain: sham controlled double blinded randomised controlled trial. BMJ 2015;350:h1640. doi:10.1136/bmj.h1640.
28. Ormerod AD, Thomas KS, Craig FE, et al, UK Dermatology Clinical Trials Network's STOP GAP Team. Comparison of the two most commonly used treatments for pyoderma gangrenosum: results of the STOP GAP randomised controlled trial. BMJ 2015;350:h2958. doi:10.1136/bmj.h2958.
29. Paul M, Bishara J, Yahav D, et al. Trimethoprim-sulfamethoxazole versus vancomycin for severe infections caused by meticillin resistant Staphylococcus aureus: randomised controlled trial. BMJ 2015;350:h2219. doi:10.1136/bmj.h2219.
30. Polyak CS, Yuhas K, Singa B, et al. Cotrimoxazole Prophylaxis Discontinuation among Antiretroviral-Treated HIV-1-Infected Adults in Kenya: A Randomized Non-inferiority Trial. PLoS Med 2016;13:e1001934. doi:10.1371/journal.pmed.1001934.
31. Robinson LJ, Wampfler R, Betuela I, et al. Strategies for understanding and reducing the Plasmodium vivax and Plasmodium ovale hypnozoite reservoir in Papua New Guinean children: a randomised placebo-controlled trial and mathematical model. PLoS Med 2015;12:e1001891. doi:10.1371/journal.pmed.1001891.
32. Selak V, Elley CR, Bullen C, et al. Effect of fxed dose combination treatment on adherence and risk factor control among patients at high risk of cardiovascular disease: randomised controlled trial in primary care. BMJ 2014;348:g3318. doi:10.1136/bmj.g3318.
33. Hrynaszkiewicz I, Norton ML, Vickers AJ, Altman DG. Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewers. BMJ 2010;340:c181. doi:10.1136/bmj.c181
34. Iqbal SA, Wallach JD, Khoury MJ, Schully SD, Ioannidis J P. Reproducible Research Practices and Transparency across the Biomedical Literature. PLoS Biol 2016;14:e1002333. doi:10.1371/journal. pbio.1002333.
35. Mailman MD, Feolo M, Jin Y, et al. The NCBI dbGaP database of genotypes and phenotypes. Nat Genet 2007;39:1181-6. doi:10.1038/ng1007-1181.
36. Keller MB, Ryan ND, Strober M, et al. Efcacy 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.
37. Le Noury J, Nardo JM, Healy D, et al. Restoring Study 329: efcacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. BMJ 2015;351:h4320. doi:10.1136/bmj.h4320
38. Laine C, Goodman SN, Griswold ME, Sox HC. Reproducible research: moving toward research the public can really trust. Ann Intern Med 2007;146:450-3. doi:10.7326/0003-4819-146-6-200703200-00154
39. Chan AW, Altman DG. Epidemiology and reporting of randomised trials published in PubMed journals. Lancet 2005;365:1159-62. doi:10.1016/S0140-6736(05)71879-1.
40. Rowhani-Farid A, Barnett AG. Has open data arrived at the British Medical Journal (BMJ)? An observational study. BMJ Open 2016;6:e011784. doi:10.1136/bmjopen-2016-011784
41. Savage CJ, Vickers AJ. Empirical study of data sharing by authors publishing in PLoS journals. PLoS One 2009;4:e7078. doi:10.1371/journal. pone.0007078.
42. Early Experiences With Journal Data Sharing Policies. A Survey of Published Clinical Trial Investigators. International Congress on Peer Review and Scientifc Publication; 2017; Chicago.
43. Ebrahim S, Sohani ZN, Montoya L, et al. Reanalyses of randomized clinical trial data. JAMA 2014;312:1024-32. doi:10.1001/jama.2014.9646.
44. Goodman SN, Fanelli D, Ioannidis JP. What does research reproducibility mean? Sci Transl Med 2016;8:341ps12. doi:10.1126/scitranslmed. aaf5027.
45. Open Science Collaboration. PSYCHOLOGY. Estimating the reproducibility of psychological science. Science 2015;349:aac4716. doi:10.1126/science. aac4716.
46. Schulz KF, Altman DG, Moher D, CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332. doi:10.1136/bmj.c332
47. Stodden V, McNutt M, Bailey DH, et al. Enhancing reproducibility for computational methods. Science 2016;354:1240-1. doi:10.1126/science. aah6168.
48. Lewandowsky S, Bishop D. Research integrity: Don't let transparency damage science. Nature 2016;529:459-61. doi:10.1038/529459a
49. Sydes MR, Johnson AL, Meredith SK, Rauchenberger M, South A, Parmar MK. Sharing data from clinical trials: the rationale for a controlled access approach. Trials 2015;16:104. doi:10.1186/s13063-015-0604-6.
50. Tudur Smith C, Hopkins C, Sydes MR, et al. How should individual participant data (IPD) from publicly funded clinical trials be shared? BMC Med 2015;13:298. doi:10.1186/s12916-015-0532-z.
51. Hopkins C, Sydes M, Murray G, et al. UK publicly funded Clinical Trials Units supported a controlled access approach to share individual participant data but highlighted concerns. J Clin Epidemiol 2016;70:17-25. doi:10.1016/j. jclinepi.2015.07.002.
52. Navar AM, Pencina MJ, Rymer JA, Louzao DM, Peterson ED. Use of Open Access Platforms for Clinical Trial Data. JAMA 2016;315: 1283-4. doi:10.1001/jama.2016.2374.