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Record W4360976230 · doi:10.1101/2023.03.24.23287707

Comparing the clinical trial characteristics of industry–funded trials and non– industry–funded trials

2023· preprint· en· W4360976230 on OpenAlexafffund
Emily Hughes, Tamara Van Bakel, Ashley Raudanskis, Prachi Ray, Benazir Hodzic-Santor, Ushma Purohit, Chana A. Sacks, Michael Fralick

Bibliographic record

VenuemedRxiv · 2023
Typepreprint
Languageen
FieldPharmacology, Toxicology and Pharmaceutics
TopicPharmaceutical industry and healthcare
Canadian institutionsLunenfeld-Tanenbaum Research InstituteSinai Health System
FundersCanadian Institutes of Health Research
KeywordsBlindingMedicineRandomized controlled trialSample size determinationClinical trialPlaceboMEDLINEFamily medicineAlternative medicineInternal medicinePathologyPolitical science

Abstract

fetched live from OpenAlex

Importance: In randomized controlled trials (RCTs), small sample size and lack of blinding can cause biased and spurious results. Whether and how study characteristics differ based on a trial's funder is an important area to study. Objective: To compare study characteristics of RCTs funded by industry with study characteristics of RCTs not funded by industry. Design, Setting and Participants: We systematically reviewed all RCTs published between 2015 and 2019 in the New England Journal of Medicine (NEJM), Lancet, and Journal of the American Medical Association (JAMA). Our primary data sources were ClinicalTrials.gov and MEDLINE. Data extraction included manual review and use of natural language processing. Main Outcomes and Measures: We compared the rate of blinding, use of placebo, and sample size. We used natural language processing to analyze the sentiment of the study's conclusion as reported in the abstract. As proxies for knowledge dissemination, we calculated the AltMetric scores and number of times the article was cited (citation count). Results: We identified 1533 RCTs published by NEJM, Lancet, and JAMA between 2015 and 2019. Of these RCTs, 697 were funded by industry. Trials funded by industry were more likely to be blinded (n=378, 54% vs n=318, 38%), more likely to include a placebo (n=317, 45% vs n=196, 23%), more likely to post their results on ClinicalTrials.gov (78%, 443 of 570 vs 41%, 207 of 501) compared to trials that were not industry funded. Industry–funded RCTs had a smaller sample size than non–industry–funded RCTs (median=557 [IQR: 230, 1369] vs 648 [IQR: 301, 1916], P<0.01). Trials funded by industry had more citations than non–industry–funded trials (285 vs 145, p < 0.01), while per–manuscript Almetric scores were similar between both groups (229 vs 226, p=0.2). Conclusions and Relevance: These data highlight important variability in key metrics of trial quality and call attention to specific areas of improvement, especially for non–industry–funded trials.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.609
metaresearch head score (Gemma)0.870
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch, Meta-epidemiology (broad)
Consensus categoriesMetaresearch
DomainCandidate signal: Methods · Consensus signal: Methods
Study designCandidate signal: Observational · Consensus signal: Observational
GenreCandidate signal: Empirical · Consensus signal: none
Teacher disagreement score0.993
Threshold uncertainty score0.483

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.6090.870
Meta-epidemiology (narrow)0.0010.001
Meta-epidemiology (broad)0.0070.013
Bibliometrics0.0190.021
Science and technology studies0.0020.006
Scholarly communication0.0070.010
Open science0.0030.005
Research integrity0.0060.005
Insufficient payload (model declined to judge)0.0050.001

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.906
GPT teacher head0.671
Teacher spread0.235 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; the direct Gemma label and the distilled Codex classifier agree on what is shown here.

Study designObservational
DomainMethods
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations0
Published2023
Admission routes2
Has abstractyes

Explore more

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