Cited by 887Research Data Management PracticesAcademic Publishing and Open AccessMeta-analysis and systematic reviews

Increasing value and reducing waste: addressing inaccessible research

Open access
Chan, An-Wen, Song, Fujian, Vickers, Andrew, Jefferson, Tom, Dickersin, Kay, Gøtzsche, Peter C, Krumholz, Harlan M, Ghersi, Davina +1 more·2014·The Lancet

Abstract

The study protocol, publications, full study report detailing all analyses, and participant-level dataset constitute the main documentation of methods and results for health research. However, journal publications are available for only half of all studies and are plagued by selective reporting of methods and results. The protocol, full study report, and participant-level dataset are rarely available. The quality of information provided in study protocols and reports is variable and often incomplete. Inaccessibility of full information for the vast majority of studies wastes billions of dollars, introduces bias, and has a detrimental impact on patient care and research. To help improve this situation at a systemic level, three main actions are warranted. Firstly, it is important that academic institutions and funders reward investigators who fully disseminate their research protocols, reports, and participant-level datasets. Secondly, standards for the content of protocols, full study reports, and data sharing practices should be rigorously developed and adopted for all types of health research. Finally, journals, funders, sponsors, research ethics committees, regulators, and legislators should implement and enforce policies supporting study registration and availability of journal publications, full study reports, and participant-level datasets.

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Crossref · 10.1016/s0140-6736(13)62296-5

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  • Protocol registration is applicable to and recommended for all studies and is supported by various platforms, such as the Open Science Framework.

    “However, protocol registration is applicable to and recommended for all studies and is supported by various platforms, such as the Open Science Framework [3, 29, 35–37].”

    From Assessing transparency practices in dental randomized controlled trials (2024) · cites this paper as [36]

    Recommendation 3 (page not available) calls for study registration across all health research, and “Identification of unpublished research” extends the discussion beyond clinical trials to systematic reviews, observational research, and preclinical experiments. The paper discusses registry infrastructure but does not identify the Open Science Framework as a platform; its recommendation is also framed around health research rather than all studies without qualification. (LLM, conf=0.86)

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  • Studies with statistically non-significant results may not have been submitted for publication, or particular results that were statistically non-significant may have been omitted from study reports.

    “studies with statistically non-significant results may not have been submitted for publication (publication bias), or particular results that were statistically non-significant may have been omitted from study reports (selective non-reporting bias).”
  • Full documentation of research, including protocols for sharing data and code, increases the value of research that is undertaken.

    “Recent reports on waste in research have highlighted that full documentation of research, including protocols for sharing data and code, increase the value of research that is undertaken.20,21”
  • A high proportion of clinical trials remain unpublished.

    “However, a high proportion of clinical trials remain unpublished.112 113”
  • The medical literature represents a biased subset of existing data, potentially leading to overestimation of benefits, underestimation of harms, and detrimental impact on patient care and research.

    “Overall, the medical literature represents a biased subset of existing data, potentially leading to overestimation of benefits, underestimation of harms, and a detrimental impact on patient care and research.112 117 118”

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Research works printed but not linked: 5

  1. [9]Chalmers I Bracken MB Djulbegovic B Garattini S Grant J Gulmezoglu AM Increasing value and reducing waste when deciding what biomedical research to do. Lancet 2014 in press
  2. [23]Sample I Harvard University says it can't afford journal publishers' prices. The Guardian 24 4 2012 Tuesday http://www.guardian.co.uk/science/2012/apr/24/harvard-university-journal-publishers-prices 21 Oct 2013
  3. [30]International Conference on Harmonisation ICH Harmonised Tripartite Guideline: Structure and content of clinical study reports. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (November 1995, E3) 1995 http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guide lines/Efficacy/E3/E3_Guideline.pdf 21 Oct 2013
  4. [70]Nature Publishing Group NPG to launch Scientific Data to help scientists publish and reuse research data http://www.nature.com/press_releases/scientificdata.html 21 Oct 2013
  5. [82]National Center for Biotechnology Information (NCBI) GEO: Gene Expression Omnibus 2013 http://www.ncbi.nlm.nih.gov/geo/ 21 Oct 2013

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Authors
Chan, A.-W., Song, F., Vickers, A., Jefferson, T., Dickersin, K., Gøtzsche, P. C., Krumholz, H. M., Ghersi, D., & van der Worp, H. B.
Affiliations
  • University of Toronto (CA)
  • University of East Anglia (GB)
  • Memorial Sloan Kettering Cancer Center (US)
  • Cochrane (GB)
  • Johns Hopkins University (US)
  • Rigshospitalet (DK)
  • Yale New Haven Hospital (US)
  • National Health and Medical Research Council (AU)
Corresponding author
Chan, An-Wen
Venue
The Lancet
Publisher
Elsevier BV
Published
2014-01
Volume
383
Issue
9913
Pages
257-266
ISSN
  • 0099-5355 (ISSN-L)
  • 0140-6736
OpenAlex
W2122908200
Cited by
887
References
116
Citations by year
2026: 20 · 2025: 47 · 2024: 60 · 2023: 54 · 2022: 71 · 2021: 116 · 2020: 71 · 2019: 74 · 2018: 68 · 2017: 84 · 2016: 103 · 2015: 69 · 2014: 48
FWCI
280.19
Type
journal article
Language
en
Open access
Locations
  • The Lancet (publishedVersion)
  • PubMed (publishedVersion)
  • Europe PMC (PubMed Central) (acceptedVersion)
  • PubMed Central (acceptedVersion)
  • UEA Digital Repository (University of East Anglia) (acceptedVersion)
  • Research at the University of Copenhagen (University of Copenhagen) (submittedVersion)
Funders
  • Prostate Cancer Foundation
  • Yale University
  • Foundation for Cardiovascular Research
  • National Institutes of Health
  • Sidney Kimmel Center for Prostate and Urologic Cancers
  • National Cancer Institute (P50 CA92629, P30CA008748, P50CA092629)
Topics
  • Physical Sciences › Computer Science › Information Systems › Research Data Management Practices
  • Social Sciences › Decision Sciences › Information Systems and Management › Academic Publishing and Open Access
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Keywords
research transparency, research registration, selective reporting, data sharing, research waste, research funding incentives, research ethics committees, science policy
MeSH terms
Clinical Trials as Topic, Humans, Periodicals as Topic, Publishing, Research Design, Publication Bias, Access to Information, Information Dissemination, Biomedical Research

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