Trial reportBMJ open2022
What drives cancer clinical trial accrual? An empirical analysis of studies leading to FDA authorisation (2015-2020).
Trial report in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed.
- AI for clinical trials in oncology.ESMO real world data and digital oncology · 2026Review
- Evaluating the impact of delayed study startup on accrual in cancer studies.Contemporary clinical trials communications · 2025Article
- Bayesian interim analysis and efficiency of phase III randomized trials.British journal of cancer · 2025Article
- Two-to-One Randomization: Rarely Advisable.JCO oncology practice · 2024Article
- Facilitation of Enrollment onto Cancer Clinical Trials Using a Novel Navigator-Assisted Program: A Cross-Sectional Study.Current oncology (Toronto, Ont.) · 2024Article
- A standing platform for cancer drug development using ctDNA-based evidence of recurrence.Nature reviews. Cancer · 2024Review
- Patient Enrollment per Month (Accrual) in Clinical Trials Leading to the FDA Approval of New Cancer Drugs.Targeted oncology · 2024Article
- Radiation therapy with phenotypic medicine: towards N-of-1 personalization.British journal of cancer · 2024Review
- Efficiency of Biomarker-Driven Clinical Trial Designs.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024Article
- Challenges for quality and utilization of real-world data for diffuse large B-cell lymphoma in REALYSA, a LYSA cohort.Blood advances · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo examine factors associated with accrual rate in industry sponsored clinical trials supporting US Food and Drug Administration (FDA) cancer drug approvals from 2015 to 2020. DESIGN, SETTING AND
participantsRetrospective cross-sectional study included 194 pivotal trials supporting cancer drug approvals by the US FDA from 2015 to 2020.
interventionsClinical trials were analysed for the type of blinding, primary endpoint, whether crossover was specified in the publication, study phase, line of therapy, response rate, investigational sites, manufacturer and randomisation ratio.
main outcome measuresThe main outcome was the rate of accrual, which is the number of patients accrued in the study per open month of enrolment.
resultsThe study consisted of 133 randomised (68%) and 61 (32%) non-randomised clinical trials. In randomised studies, we found the accrual rate was higher in trials investigating first and second line drugs (adjusted rate ratios (aRR): 1.55, 95% CI 1.18 to 2.09), phase III trials (aRR: 2.13, 95% CI 1.48 to 2.99), and for studies sponsored by Merck (aRR: 1.47, 95% CI 1.18 to 2.37), adjusting for other covariates. In contrast, the primary endpoint of a study, presence of crossover, single agent response rate, the number of investigational sites, population disease burden and skewed randomisation ratios were not associated with the rate of accrual. In the non-randomised adjusted model, the accrual rate was 2.03 higher (95% CI 1.10 to 3.92) for clinical trials sponsored by manufacturer, specifically Merck. Primary endpoint, crossover, trial phase, response rate, the number of investigational sites, disease burden or line of therapy were not associated with the rate of accrual.
conclusionIn this cross-sectional study, line of therapy, study phase and manufacturer were the only factors associated with accrual rate. These findings suggest many proffered factors for speedy trial accrual are not associated with greater enrolment rates.
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