SynthesisBMJ open2024
Operational complexities in international clinical trials: a systematic review of challenges and proposed solutions.
Synthesis in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 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
15 citing papers in PubMed.
- Parent and professional experiences of a clinical trial of prenatal and postnatal stem cell therapy for severe osteogenesis imperfecta.European journal of human genetics : EJHG · 2026Article
- Article
- Management of Increasing Complexity of Phase I Trials: A Retrospective Analysis from the Niguarda Cancer Center Phase I Unit.Therapeutic innovation & regulatory science · 2026Article
- Barriers and facilitators to recruiting older adult care home residents into clinical trials of medicines and vaccines: a scoping review.Age and ageing · 2026Article
- Development and Exploratory Validation of the Clinical Research Nursing Competencies-Self-Efficacy Scale.Healthcare (Basel, Switzerland) · 2026Article
- Clinical research in private hospitals: a perspective.Journal of translational medicine · 2026Review
- Diabetes management using a clinical guideline versus usual practice: a feasibility trial-based qualitative study among Ayurvedic practitioners and patients in Nepal.Therapeutic advances in endocrinology and metabolism · 2026Article
- Approval delays in multi-country COVID-19 trials: the case of COPCOV and the risk of therapeutic inertia.Trials · 2025Article
- Global challenges in diabetes research and care: which way forward? An appraisal from the EASD Global Council.Diabetologia · 2025Review
- Repurposing Metformin in Precision Oncology: Mechanistic Insights, Biomarker-Guided Strategies, and Translational Imperatives.Medicina (Kaunas, Lithuania) · 2025Review
- Development of a protocol complexity tool: a framework designed to stimulate discussion and simplify study design.BMC medical research methodology · 2025Article
- Master protocols in low- and middle-income countries: a review of current use, limitations and opportunities for precision medicine.BMJ global health · 2025Review
- Uncovering the Professional Landscape of Clinical Research Nursing: A Scoping Review with Data Mining Approach.Nursing reports (Pavia, Italy) · 2025Review
- Overcoming borders: International cooperation in re-use and re-interpretation of omics data in Fontan circulation.International journal of cardiology. Congenital heart disease · 2025Article
- Harnessing digital health technologies and real-world evidence to enhance clinical research and patient outcomes.Digital healthReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveInternational trials can be challenging to operationalise due to incompatibilities between country-specific policies and infrastructures. The aim of this systematic review was to identify the operational complexities of conducting international trials and identify potential solutions for overcoming them.
designSystematic review. DATA SOURCES: Medline, Embase and Health Management Information Consortium were searched from 2006 to 30 January 2023. ELIGIBILITY CRITERIA: All studies reporting operational challenges (eg, site selection, trial management, intervention management, data management) of conducting international trials were included. DATA EXTRACTION AND SYNTHESIS: Search results were independently screened by at least two reviewers and data were extracted into a proforma.
results38 studies (35 RCTs, 2 reports and 1 qualitative study) fulfilled the inclusion criteria. The median sample size was 1202 (IQR 332-4056) and median number of sites was 40 (IQR 13-78). 88.6% of studies had an academic sponsor and 80% were funded through government sources. Operational complexities were particularly reported during trial set-up due to lack of harmonisation in regulatory approvals and in relation to sponsorship structure, with associated budgetary impacts. Additional challenges included site selection, staff training, lengthy contract negotiations, site monitoring, communication, trial oversight, recruitment, data management, drug procurement and distribution, pharmacy involvement and biospecimen processing and transport.
conclusionsInternational collaborative trials are valuable in cases where recruitment may be difficult, diversifying participation and applicability. However, multiple operational and regulatory challenges are encountered when implementing a trial in multiple countries. Careful planning and communication between trials units and investigators, with an emphasis on establishing adequately resourced cross-border sponsorship structures and regulatory approvals, may help to overcome these barriers and realise the benefits of the approach. OPEN SCIENCE FRAMEWORK REGISTRATION NUMBER: osf-registrations-yvtjb-v1.
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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.