Evaluating the discoverability of supporting research materials in ClinicalTrials.gov for US federally funded COVID-19 clinical studies
DOI:
https://doi.org/10.5195/jmla.2024.1799Keywords:
Clinical studies, COVID-19, Data sharing, clinicaltrials.gov, research transparency, discoverabilityAbstract
Objective: The objective of this study was to evaluate the discoverability of supporting research materials, including supporting documents, individual participant data (IPD), and associated publications, in US federally funded COVID-19 clinical study records in ClinicalTrials.gov (CTG).
Methods: Study registration records were evaluated for (1) links to supporting documents, including protocols, informed consent forms, and statistical analysis plans; (2) information on how unaffiliated researchers may access IPD and, when applicable, the linking of the IPD record back to the CTG record; and (3) links to associated publications and, when applicable, the linking of the publication record back to the CTG record.
Results: 206 CTG study records were included in the analysis. Few records shared supporting documents, with only 4% of records sharing all 3 document types. 27% of records indicated they intended to share IPD, with 45% of these providing sufficient information to request access to the IPD. Only 1 dataset record was located, which linked back to its corresponding CTG record. The majority of CTG records did not have links to publications (61%), and only 21% linked out to at least 1 results publication. All publication records linked back to their corresponding CTG records.
Conclusion: With only 4% of records sharing all supporting document types, 12% sufficient information to access IPD, and 21% results publications, improvements can be made to the discoverability of research materials in federally funded, COVID-19 CTG records. Sharing these materials on CTG can increase their discoverability, therefore increasing the validity, transparency, and reusability of clinical research.
References
FDA guidance on conduct of clinical trials of medical products during the COVID-19 public health emergency: guidance for industry, investigators, and institutional review boards: US Food and Drug Administration; 2020 [updated March 2020, cited 2 Feb 2023]. Available from: https://www.fda.gov/media/136238/download.
Ewers M, Ioannidis JPA, Plesnila N. Access to data from clinical trials in the COVID-19 crisis: open, flexible, and time-sensitive. J Clin Epidemiol. 2021 Feb;130:143-6. DOI: 10.1016/j.jclinepi.2020.10.008.
Mitchell EJ, Ahmed K, Breeman S, Cotton S, Constable L, Ferry G, et al. It is unprecedented: trial management during the COVID-19 pandemic and beyond. Trials. 2020 Sep 11;21(1):1-7. DOI: 10.1186/s13063-020-04711-6.
Studies found for: COVID-19: ClinicalTrials.gov; [cited 2 Feb 2023]. Available from: https://clinicaltrials.gov/ct2/results?cond=COVID-19.
Rodgers F, Pepperrell T, Keestra S, Pilkington V. Missing clinical trial data: the evidence gap in primary data for potential COVID-19 drugs. Trials. 2021 Jan 15;22(1):1-10. DOI: 10.1186/s13063-021-05024-y.
Kapp P, Esmail L, Ghosn L, Ravaud P, Boutron I. Transparency and reporting characteristics of COVID-19 randomized controlled trials. BMC Med. 2022 Sep 26;20(1):1-14. DOI: 10.1186/s12916-022-02567-y.
Teixeira da Silva JA, Bornemann-Cimenti H, Tsigaris P. Optimizing peer review to minimize the risk of retracting COVID-19-related literature. Med Health Care Philos. 2021 Mar;24(1):21-6. DOI: 10.1007/s11019-020-09990-z.
Li R, von Isenburg M, Levenstein M, Neumann S, Wood J, Sim I. COVID-19 trials: declarations of data sharing intentions at trial registration and at publication. Trials. 2021 Feb 18;22(1):1-5. DOI: 10.1186/s13063-021-05104-z.
Larson K, Sim I, von Isenburg M, Levenstein M, Rockhold F, Neumann S, et al. COVID-19 interventional trials: analysis of data sharing intentions during a time of pandemic. Contemp Clin Trials. 2022 Apr;115:1-5. DOI: 10.1016/j.cct.2022.106709.
Naudet F, Siebert M, Pellen C, Gaba J, Axfors C, Cristea I, et al. Medical journal requirements for clinical trial data sharing: ripe for improvement. PLoS Med. 2021 Oct;18(10):1-8. DOI: 10.1371/journal.pmed.1003844.
Mello MM, Lieou V, Goodman SN. Clinical trial participants' views of the risks and benefits of data sharing. N Engl J Med. 2018 Jun 7;378(23):2202-11. DOI: 10.1056/NEJMsa1713258.
Final NIH policy for data management and sharing NOT-OD-21-013: National Institutes of Health; 2020 [cited 2 Feb 2023]. Available from: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html.
Chen R, Desai NR, Ross JS, Zhang W, Chau KH, Wayda B, et al. Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers. Bmj. 2016 Feb 17;352:i637. DOI: 10.1136/bmj.i637.
Jones CW, Adams AC, Murphy E, King RP, Saracco B, Stesis KR, et al. Delays in reporting and publishing trial results during pandemics: cross sectional analysis of 2009 H1N1, 2014 Ebola, and 2016 Zika clinical trials. BMC Med Res Methodol. 2021 Jun 8;21(1):1-10. DOI: 10.1186/s12874-021-01324-8.
Naudet F, Sakarovitch C, Janiaud P, Cristea I, Fanelli D, Moher D, et al. 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. 2018 Feb 13;360:1-11. DOI: 10.1136/bmj.k400.
Taichman DB, Sahni P, Pinborg A, Peiperl L, Laine C, James A, et al. Data sharing statements for clinical trials. Bmj. 2017 Jun 5;357:1-3. DOI: 10.1136/bmj.j2372.
NIH policy on the dissemination of NIH-funded clinical trial information NOT-OD-16-149: National Institutes of Health Office of Science Policy; 2016 [cited 2 Feb 2023]. Available from: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-149.html.
42 CFR Part II: clinical trials registration and results information submission; Final Rule: Department of Health and Human Services; 2016. NIH–2011–0003 [cited 2 Feb 2023]. Available from: https://www.ecfr.gov/current/title-42/chapter-I/subchapter-A/part-11.
Public health emergency COVID-19 initiative: National Library of Medicine; 2022 [cited 2 Feb 2023]. Available from: https://www.ncbi.nlm.nih.gov/pmc/about/covid-19/.
Sharing research data and findings relevant to the novel coronavirus (COVID-19) outbreak: Wellcome Trust; 2020 [cited 2 Feb 2023]. Available from: https://wellcome.org/press-release/sharing-research-data-and-findings-relevant-novel-coronavirus-ncov-outbreak.
A letter to members of the scholarly publishing community: National Science and Technology Advisors; 2020 [cited 2 Feb 2023]. Available from: https://www.imagwiki.nibib.nih.gov/sites/default/files/COVID19%20Open%20Access%20Letter%20from%20CSAs.Equivalents_0.pdf.
Nelson A. Memorandum: ensuring free, immediate, and equitable access to federally funded research: Office of Science and Technology Policy; 2022 [cited 2 Feb 2023]. Available from: https://www.whitehouse.gov/wp-content/uploads/2022/08/08-2022-OSTP-Public-Access-Memo.pdf.
ClinicalTrials.gov background: ClinicalTrials.gov; 2021 [cited 2 Feb 2023]. Available from: https://clinicaltrials.gov/ct2/about-site/background#WhatInformationCanIFind.
ClinicalTrials.gov protocol registration data element definitions for interventional and observational studies: ClinicalTrials.gov; 2020 [cited 2 Feb 2023]. Available from: https://prsinfo.clinicaltrials.gov/definitions.html.
Mayer CS, Huser V. regCOVID: tracking publications of registered COVID-19 studies. BMC Med Res Methodol. 2022 Aug 10;22(1):1-10. DOI: 10.1186/s12874-022-01703-9.
Glossary of common site terms: ClinicalTrials.gov; 2021 [cited 2 Feb 2023]. Available from: https://clinicaltrials.gov/ct2/about-studies/glossary.
Salholz-Hillel M, Strech D, Carlisle BG. Results publications are inadequately linked to trial registrations: an automated pipeline and evaluation of German university medical centers. Clin Trials. 2022 Apr 1:337-46. DOI: 10.1177/17407745221087456.
Bashir R, Bourgeois FT, Dunn AG. A systematic review of the processes used to link clinical trial registrations to their published results. Syst Rev. 2017 Jul 3;6(1):1-17. DOI: 10.1186/s13643-017-0518-3.
Huser V, Cimino JJ. Precision and negative predictive value of links between ClinicalTrials.gov and PubMed. AMIA Annu Symp Proc. 2012;2012:400-8.
How to find results of studies: ClinicalTrials.gov; 2021 [cited 2 Feb 2023]. Available from: https://clinicaltrials.gov/ct2/help/how-find/find-study-results.
Email from NLM Support Team. Email message to: Paije Wilson. National Library of Medicine Help Desk; 2023
MEDLINE/PubMed data element (field) descriptions: National Library Of Medicine; 2019 [cited 2 Feb 2023]. Available from: https://www.nlm.nih.gov/bsd/mms/medlineelements.html#si.
PubMed user guide: National Library of Medicine; 2023 [cited 2 Feb 2023]. Available from: https://pubmed.ncbi.nlm.nih.gov/help/#tw.
Ohmann C, Moher D, Siebert M, Motschall E, Naudet F. Status, use and impact of sharing individual participant data from clinical trials: a scoping review. BMJ Open. 2021 Aug 18;11(8):1-21. DOI: 10.1136/bmjopen-2021-049228.
Gaba JF, Siebert M, Dupuy A, Moher D, Naudet F. Funders' data-sharing policies in therapeutic research: a survey of commercial and non-commercial funders. PLoS One. 2020;15(8):1-14. DOI: 10.1371/journal.pone.0237464.
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. 2017 Jun;14(6):1-3. DOI: 10.1371/journal.pmed.1002315.
Bergeris A, Tse T, Zarin DA. Trialists' intent to share individual participant data as disclosed at ClinicalTrials.gov. Jama. 2018 Jan 23;319(4):406-8. DOI: 10.1001/jama.2017.20581. Available from: https://jamanetwork.com/journals/jama/articlepdf/2670243/jama_bergeris_2018_ld_170053.pdf.
Watson C. Many researchers say they'll share data - but don't. Nature. 2022 Jun;606(7916):853. DOI: 10.1038/d41586-022-01692-1.
Piwowar HA, Vision TJ. Data reuse and the open data citation advantage. PeerJ. 2013;1:1-25. DOI: 10.7717/peerj.175.
Colavizza G, Hrynaszkiewicz I, Staden I, Whitaker K, McGillivray B. The citation advantage of linking publications to research data. PLoS One. 2020;15(4):1-18. DOI: 10.1371/journal.pone.0230416.
Data Confidentiality: ICPSR's Approach to Confidentiality; 2023 [cited 7 Oct 2023]. Available from: https://www.icpsr.umich.edu/web/pages/datamanagement/confidentiality/index.html.
Clinical trials: International Committee of Medical Journal Editors; 2023 [cited 2 Feb 2023]. Available from: https://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html.
Downloads
Additional Files
Published
Issue
Section
License
Copyright (c) 2023 Paije Wilson, Vojtech Huser
![Creative Commons License](http://i.creativecommons.org/l/by/4.0/88x31.png)
This work is licensed under a Creative Commons Attribution 4.0 International License.