Cited by 27Meta-analysis and systematic reviewsAcademic Publishing and Open Accessscientometrics and bibliometrics research

Trends and predictors of biomedical research quality, 1990-2015: a meta-research study

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Catillon, Maryaline·2019·BMJ Open

Abstract

OBJECTIVE: To measure the frequency of adequate methods, inadequate methods and poor reporting in published randomised controlled trials (RCTs) and test potential factors associated with adequacy of methods and reporting. DESIGN: Retrospective analysis of RCTs included in Cochrane reviews. Time series describes the proportion of RCTs using adequate methods, inadequate methods and poor reporting. A multinomial logit model tests potential factors associated with methods and reporting, including funding source, first author affiliation, clinical trial registration status, study novelty, team characteristics, technology and geography. DATA: Risk of bias assessments for random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data and selective reporting, for each RCT, were mapped to bibliometric and funding data. OUTCOMES: Risk of bias on six methodological dimensions and RCT-level overall assessment of adequate methods, inadequate methods or poor reporting. RESULTS: This study analysed 20 571 RCTs. 5.7% of RCTs used adequate methods (N=1173). 59.3% used inadequate methods (N=12 190) and 35.0% were poorly reported (N=7208). The proportion of poorly reported RCTs decreased from 42.5% in 1990 to 30.2% in 2015. The proportion of RCTs using adequate methods increased from 2.6% in 1990 to 10.3% in 2015. The proportion of RCTs using inadequate methods increased from 54.9% in 1990 to 59.5% in 2015. Industry funding, top pharmaceutical company affiliation, trial registration, larger authorship teams, international teams and drug trials were associated with a greater likelihood of using adequate methods. National Institutes of Health funding and university prestige were not. CONCLUSION: Even though reporting has improved since 1990, the proportion of RCTs using inadequate methods is high (59.3%) and increasing, potentially slowing progress and contributing to the reproducibility crisis. Stronger incentives for the use of adequate methods are needed.

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  • A recent study analyzed 20,571 RCTs from biomedical research and found improvements in reporting since 1990; however, in 2015, 30.2% of RCTs were still poorly reported.

    “A recent study analyzed 20,571 RCTs from biomedical research and found improvements in reporting since 1990. However, in 2015, 30.2% of RCTs were still poorly reported 32 .”

    From Global mapping of randomized controlled trials in dentistry (2024) · cites this paper as [32]

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  • Nearly 60% of RCTs in biomedical research used inappropriate methods, according to a recent study.

    “Nearly 60% of RCTs in biomedical research used inappropriate methods, according to a recent study 32 .”

    From Global mapping of randomized controlled trials in dentistry (2024) · cites this paper as [32]

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Authors
Catillon, M.
Affiliations
Harvard University (US)
Corresponding author
Catillon, Maryaline
Venue
BMJ Open
Publisher
BMJ
Published
2019-09
Volume
9
Issue
9
Pages
e030342
ISSN
2044-6055 (ISSN-L)
OpenAlex
W2971384056
Cited by
27
References
68
Citations by year
2026: 2 · 2025: 3 · 2024: 6 · 2023: 5 · 2022: 5 · 2021: 5 · 2020: 1
FWCI
0.56
Type
journal article
Language
en
Open access
Licence
cc-by-nc
Locations
  • BMJ Open (publishedVersion, cc-by-nc)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
  • HighWire Press Open Archive (submittedVersion)
Funders
  • National Institutes of Health
  • National Institute on Aging (R24AG048059)
Topics
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
  • Social Sciences › Decision Sciences › Information Systems and Management › Academic Publishing and Open Access
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › scientometrics and bibliometrics research
Keywords
randomized controlled trials, research quality, reporting quality, risk of bias, clinical trial registration, industry funding, international research teams, drug trials, replication crisis, funding sources, temporal trends
MeSH terms
Humans, Prognosis, Retrospective Studies, Randomized Controlled Trials as Topic, Quality Indicators, Health Care

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