Clinical Trial Registries, Results Databases, and Research Data Repositories

  • Karmela Krleža-JerićEmail author
Part of the Health Informatics book series (HI)


Trial registration, results disclosure, and sharing of analyzable data are considered powerful tools for achieving higher levels of transparency and accountability for clinical trials. The emphasis on disseminating knowledge and growing demands for transparency in clinical research are contributing to a major paradigm shift in health research. In this new paradigm, knowledge will be generated from the culmination of all existing knowledge – not just from bits and parts of previous knowledge, as is largely the case now. The full transparency of clinical research is a powerful strategy to diminish publication bias, increase accountability, avoid unnecessary duplication of research (and thus avoid research waste), efficiently advance research, provide more reliable evidence for diagnostic and therapeutic interventions, and regain public trust. Transparency of clinical trials, at a minimum, means sharing information about the design, conduct, results, and analyzable data. Not only must the information itself be explicitly documented, but an access location or medium for distribution must be provided. In the case of clinical trials, the public disclosure of data is realized by posting cleaned and anonymized data in well-defined, freely accessible clinical trial registries and results databases. Making cleaned, anonymized individual participant data sets analyzable is still a challenge.

Basic electronic tools that enable sharing clinical trial information include registries hosting protocol data, results databases hosting aggregate data, and research data repositories hosting reusable/analyzable data sets and other research-related information. These tools are at different levels of development and plagued with heterogeneity as international standards exist only for trial registration. The lack of standards related to publishing data in repositories makes it difficult for researchers to decide where to publish and search for data from completed studies.


Transparency in clinical research Trial registries International standards Results databases Protocol-Results-Data Cleaned Anonymized individual participant data (IPD) Analyzable data Research data repositories Reuse of data-Open data User perspectives 



The author would like to thank Nevena Jeric at Apropo Media for graphic design.


The views expressed here are the author’s and do not represent the views of the MedILS or any other organization.


  1. 1.
    Vickers AJ. Sharing raw data from clinical trials: what progress since we first asked “Whose data set is it anyway?” Trials [Internet]. 2016;17:227. Available from:
  2. 2.
    Krleža-Jerić K. Clinical trial registration: the differing views of industry, the WHO, and the Ottawa Group. PLoS Med. 2005;2:1093–7.CrossRefGoogle Scholar
  3. 3.
    Clinical Study Data Request [Internet]. [cited 2016 Sep 1]. Available from:
  4. 4.
    YODA Project [Internet]. [cited 2016 Jul 19]. Available from:
  5. 5.
    Project Data Sphere [Internet]. [cited 2016 Aug 1]. Available from:
  6. 6.
    Vivli-A global clinical trial data sharing platform: proposal, definition and scope background and objectives; 2016 June.Google Scholar
  7. 7.
    The Vivli Platform is live – Vivli [Internet]. [cited 2018 Aug 23]. Available from:
  8. 8.
    European Medicines Agency – clinical data publication – documents from advisory groups on clinical-trial data [Internet]. [cited 2018 Aug 21]. Available from:
  9. 9.
    Krleža-Jerić K. Sharing of data from clinical trials and research integrity. In: Steneck N, Anderson M, Kleinert S, Mayer T, editors. Integrity in the Global Research Arena; Proceedings of the World Conference on Research Integrity. 3rd ed. Montreal, Quebec, Singapore: World Scientific Publishing; 2013. p. 91.CrossRefGoogle Scholar
  10. 10.
    Krleža-Jerić K. Sharing of clinical trial data and research integrity. Period Biol. 2014;116(4):337–9.Google Scholar
  11. 11.
    Krleža-Jerić K. Clinical trials registries and results databases. In: Ritchesson RL, Andrews JE, editors. Clinical research informatics. London: Springer; 2012. p. 389–408.CrossRefGoogle Scholar
  12. 12.
    Bass A. Side effects; a prosecutor, whistelblower, and a bestselling antidepressant on trial. 1st ed. Chapel Hill: Algonquin Books; 2008. 260 p.Google Scholar
  13. 13.
    Gibson L. GlaxoSmithKline to publish clinical trials after US lawsuit. BMJ. 2004;328(7455):1513.CrossRefGoogle Scholar
  14. 14.
    DeAngelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Clinical trial registration: a statement from the international committee of medical journal editors. JAMA [Internet]. 2004 [cited 2016 Jul 13];292(11):1363–4. Available from: Scholar
  15. 15.
    Krleža-Jerić K, Chan A-W, Dickersin K, Sim I, Grimshaw J, Gluud C. Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1). BMJ [Internet]. 2005 [cited 2016 Jul 14];330(7497):956–8. Available from:
  16. 16.
    The Mexico Statement on Health Research [Internet]. Mexico City; Available from:
  17. 17.
    International Clinical Trials Registry Platform (ICRTP) [Internet]. [cited 2016 Jul 12]. Available from:
  18. 18.
    Mahmić-Kaknjo M, Šimić J, Krleža-Jerić K. Setting the impact (improve access to clinical trial data) observatory baseline. Biochem Med. 2018;28(1):7–15. 010201. Scholar
  19. 19.
    Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7.CrossRefGoogle Scholar
  20. 20.
    Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ [Internet]. 2013;346:e7586. Available from:
  21. 21.
    The SPIRIT Statement [Internet]. [cited 2018 Aug 17]. Available from:
  22. 22.
    El Emam K, Jonker E, Sampson M, Krleža-Jerić K, Neisa A. The use of electronic data capture tools in clinical trials: web-survey of 259 Canadian trials. J Med Internet Res [Internet]. 2009;11(1):e8. Available from:
  23. 23.
    WHO Trial registration Data set version 1.3.1. [Internet]. [cited 2018 Aug 19]. Available from:
  24. 24.
    Reveiz L, Chan A-W, Krleža-Jerić K, Granados CE, Pinart M, Etxeandia I, et al. Reporting of methodologic information on trial registries for quality assessment: a study of trial records retrieved from the WHO search portal. PLoS One [Internet]. 2010;5(8):e12484. Available from: Scholar
  25. 25.
    WHO|The WHO Registry Network [Internet]. WHO. World Health Organization; 2016 [cited 2018 Aug 17]. Available from:
  26. 26.
    Reveiz L, Krleža-Jerić K, Chan A-W, de Aguiar S. Do trialists endorse clinical trial registration? Survey of a Pubmed sample. Trials [Internet]. 2007;8:30. Available from:
  27. 27.
    WMA Declaration of Helsinki – ethical principles for medical research involving human subjects – WMA – The World Medical Association [Internet]. 2013 [cited 2018 Aug 20]. Available from:
  28. 28.
    Krleža-Jerić K, Lemmens T. 7th revision of the Declaration of Helsinki: good news for the transparency of clinical trials. Croat Med J [Internet]. 2009 [cited 2016 Jul 14];50(2):105–10. Available from: Scholar
  29. 29.
    Goodyear MDE, Krleza-Jeric K, Lemmens T. The Declaration of Helsinki. BMJ [Internet]. 2007 [cited 2016 Jul 14];335(7621):624–5. Available from:
  30. 30.
    Krleža-Jerić K, Lemmens T, Reveiz L, Cuervo LG, Bero LA. Prospective registration and results disclosure of clinical trials in the Americas: a roadmap toward transparency. Rev Panam Salud Publica [Internet]. 2011 [cited 2016 Jun 16];30(1):87–96. Available from:
  31. 31.
    Zarin DA, Tse T, Williams RJ, Rajakannan T. The status of trial registration eleven years after the ICMJE policy. N Engl J Med [Internet]. 2017;376(4):383–91. Available from: Scholar
  32. 32.
    Rising K, Bacchetti P, Bero L. Reporting bias in drug trials submitted to the food and drug administration: review of publication and presentation. Ioannidis J, editor. PLoS Med [Internet]. 2008;5(11):e217. Available from:
  33. 33.
    CDISC [Internet]. [cited 2018 Aug 20]. Available from:
  34. 34.
    Harriman SL, Patel J. When are clinical trials registered? An analysis of prospective versus retrospective registration. Trials [Internet]. 2016;17:187. Available from:
  35. 35.
    Viergever RF, Karam G, Reis A, Ghersi D. The quality of registration of clinical trials: still a problem. Scherer RW, editor. PLoS One [Internet]. 2014;9(1):e84727. Available from: Scholar
  36. 36.
    Food and Drug Administration Amendments Act (FDAAA) of 2007 [Internet]. Office of the Commissioner; [cited 2018 Aug 22]. Available from:
  37. 37.
    Prospero-International prospective register of systematic reviews [Internet]. [cited 2018 Aug 21]. Available from:
  38. 38.
    Australia Clinical Trials Toolkit|Australian Clinical Trials [Internet]. [cited 2018 Aug 22]. Available from:
  39. 39.
    Australia New Zealand Clinical Trials Registry. Data item definition/explanation [Internet]. [cited 2018 Aug 14]. Available from:
  40. 40.
    Zarin DA, Tse T, Ide NC. Trial registration at between May and October 2005. N Engl J Med [Internet]. 2005;353(26):2779–87. Available from: Scholar
  41. 41.
    Askie LM, Hunter KE, Berber S, Langford A, Tan-Koay AG, Vu T, Sausa R, Seidler AL, Ko H SR. The clinical trials landscape in Australia 2006–2015 [Internet]. Sydney: Australian New Zealand Clinical Trials Registry; 2017 [cited 2018 Aug 19]. 83 p. Available from:,557,766.
  42. 42.
    Krleža-Jerić K. International dialogue on the public reporting of clinical trial outcome and results – PROCTOR meeting. Croat Med J. 2008;49:267–8.CrossRefGoogle Scholar
  43. 43.
    Krleža-Jerić K, Gabelica M, Banzi R, Martinić MK, Pulido B, Mahmić-Kaknjo M, et al. IMPACT Observatory: tracking the evolution of clinical trial data sharing and research integrity. Biochem Medica [Internet]. 2016;26(3):308–17. Available from:,
  44. 44.
    Ohmann C, Banzi R, Canham S, Battaglia S, Matei M, Ariyo C, et al. Sharing and reuse of individual participant data from clinical trials: principles and recommendations. BMJ Open [Internet]. 2017;7(12):e018647. Available from:
  45. 45.
    Bian Z-X, Wu T-X. Legislation for trial registration and data transparency. Trials [Internet]. 2010;11(1):64. Available from: Scholar
  46. 46.
    El Emam K, Rodgers S, Malin B. Anonymising and sharing individual patient data. BMJ [Internet]. 2015;350:h1139. Available from: Scholar
  47. 47.
    Collins F. Has the revolution arrived? Nature [Internet]. 2010;464(7289):674–5. Available from: Scholar
  48. 48.
    Collins FS, Green ED, Guttmacher AE, Guyer MS. A vision for the future of genomics research. Nature [Internet]. 2003;422:835. Available from: Scholar
  49. 49.
    Taichman DB, Sahni P, Pinborg A, Peiperl L, Laine C, James A, et al. Data sharing statements for clinical trials: a requirement of the International Committee of Medical Journal Editors. PLoS Med [Internet]. 2017;14(6):e1002315. Available from: Scholar
  50. 50.
    Gøtzsche PC. Why we need easy access to all data from all clinical trials and how to accomplish it. Trials [Internet]. 2011 [cited 2018 Aug 20];12(1):249. Available from:
  51. 51.
    Zarin DA, Tse T. Sharing Individual Participant Data (IPD) within the Context of the Trial Reporting System (TRS). PLoS Med [Internet]. 2016;13(1):e1001946. Available from: Scholar
  52. 52.
    Rockhold F, Nisen P, Freeman A. Data sharing at a crossroads. N Engl J Med [Internet]. 2016 [cited 2018 Aug 13];375(12):1115–7. Available from: Scholar
  53. 53.
    Eichler H-G, Abadie E, Breckenridge A, Leufkens H, Rasi G, Doshi P, et al. Open clinical trial data for all? A view from regulators. PLoS Med [Internet]. 2012 [cited 2016 Jul 14];9(4):e1001202. Available from: Scholar
  54. 54.
    Re3Data; Registry of Research Data Repositories [Internet]. [cited 2018 Aug 12]. Available from:
  55. 55.
    Krleza-Jeric K, Hrynaszkiewicz I. Environmental Scan of Repositories of Clinical Research Data: How Far Have We Got With Public Disclosure of Trial Data? [Internet]. figshare; 2018. Available from:
  56. 56.
    Krleza-Jeric K, Gabelica M, Mahmic-Kaknjo M, Malicki M, Utrobicic A, Simic J, et al. Setting of an Observatory of clinical trial transition regarding data sharing; IMPACT Observatory. Poster, Cochrane Colloquium Vienna, 2015. Available from:
  57. 57.
    Gabelica M, Martinic MK, Luksic D, Krleza-Jeric K. Clinical trial transparency and data repositories; an environmental scan of the IMPACT (Improving Access to Clinical Trial Data) Observatory. Poster, 8th Croatian Cochrane Symposium, Split. 2016. Available from:
  58. 58.
    UMIN-ICDR Individual Case data repository [Internet]. [cited 2018 Aug 12]. Available from:
  59. 59.
    Edinburgh DataShare [Internet]. [cited 2018 Aug 19]. Available from:
  60. 60.
    The Dataverse Project [Internet]. [cited 2018 Aug 19]. Available from:
  61. 61.
    Harvard Dataverse [Internet]. [cited 2018 Aug 20]. Available from:
  62. 62.
    Research Data Alliance RDA [Internet]. [cited 2018 Aug 17]. Available from:
  63. 63.
    CoreTrustSeal [Internet]. [cited 2018 Jun 28]. Available from:
  64. 64.
    Pampel H, Vierkant P, Scholze F, Bertelmann R, Kindling M, Klump J, et al. Making research data repositories visible: the registry. PLoS One. 2013;8(11):e78080.CrossRefGoogle Scholar
  65. 65.
    Persistent Identifier [Internet]. [cited 2018 Aug 19]. Available from:
  66. 66.
    DataCite [Internet]. [cited 2018 Aug 12]. Available from:

Copyright information

© Springer International Publishing 2019

Authors and Affiliations

  1. 1.IMPACT Observatory, Mediterranean Institute for Life Sciences- MedILS, Split & Cochrane Croatia, University of Split School of MedicineSplitCroatia
  2. 2.Electronic Health Information Laboratory -EHIL, CHEOOttawaCanada

Personalised recommendations