SynthesisBMJ open2023
Use of external control arms in immune-mediated inflammatory diseases: a systematic review.
Synthesis in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 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
7 citing papers in PubMed, 5 citations in OpenAlex.
- Anifrolumab Plus Standard of Care Reduces Long-Term Cardiovascular Damage in Adults With Systemic Lupus Erythematosus: Findings From a Real-World External Control Study.ACR open rheumatology · 2026Article
- How can innovative trials in juvenile idiopathic arthritis serve the unmet needs of patients?Arthritis research & therapy · 2026Review
- Supplementing Single-Arm Trials with External Control Arms-Evaluation of German Real-World Data.Clinical pharmacology and therapeutics · 2025Article
- Synthetic Data in Healthcare and Drug Development: Definitions, Regulatory Frameworks, Issues.CPT: pharmacometrics & systems pharmacology · 2025Review
- A Framework for the Use and Likelihood of Regulatory Acceptance of Single-Arm Trials.Therapeutic innovation & regulatory science · 2024Review
- Navigating the complexities of drug development for inflammatory bowel disease.Nature reviews. Drug discovery · 2024Review
- Toward Patient Centricity: Why Do Patients With Inflammatory Bowel Disease Participate in Pharmaceutical Clinical Trials? A Mixed-Methods Exploration of Study Participants.Crohn's & colitis 360 · 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
11 authors at 3 institutions in 2 countries.
Funding
Abstract
objectivesExternal control arms (ECAs) provide useful comparisons in clinical trials when randomised control arms are limited or not feasible. We conducted a systematic review to summarise applications of ECAs in trials of immune-mediated inflammatory diseases (IMIDs).
designSystematic review with an appraisal of ECA source quality rated across five domains (data collection, study populations, outcome definitions, reliability and comprehensiveness of the dataset, and other potential limitations) as high, low or unclear quality. DATA SOURCES: Embase, Medline and Cochrane Central Register of Controlled Trial were searched through to 12 September 2023. ELIGIBILITY CRITERIA: Eligible studies were single-arm or randomised controlled trials (RCTs) of inflammatory bowel disease, pouchitis, rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis and atopic dermatitis in which an ECA was used as the comparator. DATA EXTRACTION AND SYNTHESIS: Two authors independently screened the search results in duplicate. The characteristics of included studies, external data source(s), outcomes and statistical methods were recorded, and the quality of the ECA data source was assessed by two independent authors.
resultsForty-three studies met the inclusion criteria (inflammatory bowel disease: 16, pouchitis: 1, rheumatoid arthritis: 12, juvenile idiopathic arthritis: 1, ankylosing spondylitis: 5, psoriasis: 3, multiple indications: 4). The majority of these trials were single-arm (33/43) and enrolled adult patients (34/43). All included studies used a historical control rather than a contemporaneous ECA. In RCTs, ECAs were most often derived from the placebo arm of another RCT (6/10). In single-arm trials, historical case series were the most common ECA source (19/33). Most studies (31/43) did not employ a statistical approach to generate the ECA from historical data.
conclusionsStandardised ECA methodology and reporting conventions are lacking for IMIDs trials. The establishment of ECA reporting guidelines may enhance the rigour and transparency of future research.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.