Discoverability of information on clinical trial data-sharing platforms
Keywords:clinical trials, data sharing platforms, data sharing
Objective: This study was intended to (1) provide clinical trial data-sharing platform designers with insight into users’ experiences when attempting to evaluate and access datasets, (2) spark conversations about improving the transparency and discoverability of clinical trial data, and (3) provide a partial view of the current information-sharing landscape for clinical trials.
Methods: We evaluated preview information provided for 10 datasets in each of 7 clinical trial data-sharing platforms between February and April 2019. Specifically, we evaluated the platforms in terms of the extent to which we found (1) preview information about the dataset, (2) trial information on ClinicalTrials.gov and other external websites, and (3) evidence of the existence of trial protocols and data dictionaries.
Results: All seven platforms provided data previews. Three platforms provided information on data file format (e.g., CSV, SAS file). Three allowed batch downloads of datasets (i.e., downloading multiple datasets with a single request), whereas four required separate requests for each dataset. All but one platform linked to ClinicalTrials.gov records, but only one platform had ClinicalTrails.gov records that linked back to the platform. Three platforms consistently linked to external websites and primary publications. Four platforms provided evidence of the presence of a protocol, and six platforms provided evidence of the presence of data dictionaries.
Conclusions: More work is needed to improve the discoverability, transparency, and utility of information on clinical trial data-sharing platforms. Increasing the amount of dataset preview information available to users could considerably improve the discoverability and utility of clinical trial data.
Dijkers MP. A beginner’s guide to data stewardship and data sharing. Spinal Cord. 2019 Mar;57(3):169–82.
Cooper D, Springer R. Data Communities: A New Model for Supporting STEM Data Sharing [Internet]. Ithaka S+R; 2019 May [cited 2019 Aug 6]. Available from: http://sr.ithaka.org/?p=311396
Naudet F, Sakarovitch C, Janiaud P, Cristea I, Fanelli D, Moher D, Ioannidis JPA. 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 [Internet]. 2018 Feb 13 [cited 2019 Aug 6];k400. Available from: http://www.bmj.com/lookup/doi/10.1136/bmj.k400
Plantin J-C, Lagoze C, Edwards PN. Re-integrating scholarly infrastructure: The ambiguous role of data sharing platforms. Big Data Soc [Internet]. 2018 Jun [cited 2019 Aug 6];5(1):205395171875668. Available from: http://journals.sagepub.com/doi/10.1177/2053951718756683
Popkin G. Data sharing and how it can benefit your scientific career. Nature [Internet]. 2019 May [cited 2019 Aug 6];569(7756):445–7. Available from: http://www.nature.com/articles/d41586-019-01506-x
Howe N, Giles E, Newbury-Birch D, McColl E. Systematic review of participants’ attitudes towards data sharing: a thematic synthesis. J Health Serv Res Policy [Internet]. 2018 Apr [cited 2019 Aug 6];23(2):123–33. Available from: http://journals.sagepub.com/doi/10.1177/1355819617751555
Taichman DB, Sahni P, Pinborg A, Peiperl L, Laine C, James A, Hong S-T, Haileamlak A, Gollogly L, Godlee F, Frizelle FA, Florenzano F, Drazen JM, Bauchner H, Baethge C, Backus J. Data Sharing Statements for Clinical Trials — A Requirement of the International Committee of Medical Journal Editors. N Engl J Med [Internet]. 2017 Jun 8 [cited 2019 Aug 6];376(23):2277–9. Available from: http://www.nejm.org/doi/10.1056/NEJMe1705439
A Platform for Biomedical Discovery and Data-Powered Health: National Library of Medicine Strategic Plan 2017-2027 [Internet]. National Library of Medicine; 2017. Available from: https://www.nlm.nih.gov/pubs/plan/lrp17/NLM_StrategicReport2017_2027.html
NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information [Internet]. National Institutes of Health; 2016. Available from: https://grants.nih.gov/grants/guide/notice-files/not-od-16-149.html
NIH Strategic Plan for Data Science [Internet]. National Institutes of Health; 2018. Available from: https://datascience.nih.gov/sites/default/files/NIH_Strategic_Plan_for_Data_Science_Final_508.pdf
Food and Drug Administration. FDAAA 801 and the Final Rule [Internet]. ClinicalTrials.gov; 2007. Available from: https://clinicaltrials.gov/ct2/manage-recs/fdaaa
Huser V, Shmueli-Blumberg D. Data sharing platforms for de-identified data from human clinical trials. Clin Trials [Internet]. 2018 Aug [cited 2019 Aug 6];15(4):413–23. Available from: http://journals.sagepub.com/doi/10.1177/1740774518769655
Spence O, Onwuchekwa Uba R, Shin S, Doshi P. Patient consent to publication and data sharing in industry and NIH-funded clinical trials. Trials [Internet]. 2018 Dec [cited 2019 Aug 6];19(1):269. Available from: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2651-2
Amorim RC, Castro JA, da Silva JR, Ribeiro C. A Comparative Study of Platforms for Research Data Management: Interoperability, Metadata Capabilities and Integration Potential. In: Rocha A, Correia AM, Costanzo S, Reis LP, editors. New Contributions in Information Systems and Technologies [Internet]. Cham: Springer International Publishing; 2015 [cited 2019 Aug 6]. p. 101–11. Available from: http://link.springer.com/10.1007/978-3-319-16486-1_10
Banzi R, Canham S, Kuchinke W, Krleza-Jeric K, Demotes-Mainard J, Ohmann C. Evaluation of repositories for sharing individual-participant data from clinical studies. Trials [Internet]. 2019 Dec [cited 2019 Aug 6];20(1):169. Available from: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3253-3
ClinicalTrials.gov [Internet]. U.S. National Institutes of Health; Available from: https://clinicaltrials.gov/
Wallis JC, Rolando E, Borgman CL. If we share data, will anyone use them? Data sharing and reuse in the long tail of science and technology. PLoS One. 2013 Jul 23;8(7):e67332.
Anderson ML, Peterson ED. Compliance with results reporting at ClinicalTrials.gov. N Engl J Med. 2015 Jun 11;372(24):2370-1.
Wilkinson T, Sinha S, Peek N, Geifman N. Clinical trial data reuse - overcoming complexities in trial design and data sharing. Trials. 2019 Aug 19;20(1):513.
Chan A-W, Hróbjartsson A. Promoting public access to clinical trial protocols: challenges and recommendations. Trials [Internet]. 2018 Dec [cited 2019 Aug 6];19(1):116. Available from: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2510-1
Sutton A, Galvan De La Cruz MC, Leaviss J, Booth A. Searching for trial protocols: A comparison of methods. Res Synth Methods. 2018 Dec;9(4):551–60.
Hyrnaszkiewicz I. Building trust to break down barriers. The State of Open Data Report 2019. Figshare Report. 2019. https://doi.org/10.6084/m9.figshare.9980783.v2
Tudur Smith C, Hopkins C, Sydes MR, Woolfall K, Clarke M, Murray G, Williamson P. How should individual participant data (IPD) from publicly funded clinical trials be shared? BMC Med. 2015 Dec 17;13:298.
Shabani M, Obasa M. Transparency and objectivity in governance of clinical trials data sharing: Current practices and approaches. Clin Trials. 2019 Oct;16(5):547-551.
Rockhold F, Bromley C, Wagner EK, Buyse M. Open science: The open clinical trials data journey. Clin Trials. 2019 Oct;16(5):539-546. doi: 10.1177/1740774519865512. Epub 2019 Jul 26.
Christensen G, Dafoe A, Miguel E, Moore DA, Rose AK. A study of the impact of data sharing on article citations using journal policies as a natural experiment. PLoS One. 2019 Dec 18;14(12):e0225883.
Mayer CS, Williams N, Huser V. Analysis of data dictionary formats of HIV clinical trials. PLoS One. 2020 Oct 5;15(10):e0240047. doi: 10.1371/journal.pone.0240047.