ArticleContemporary clinical trials communications2018
Building clinical trials around patients: Evaluation and comparison of decentralized and conventional site models in patients with low back pain.
Article in Contemporary clinical trials communications, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 3 of them syntheses that pooled it.
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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.
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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.
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Who cites it
40 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Recommendations to promote equity, diversity and inclusion in decentralized clinical trials.Nature medicine · 2024Guideline
- A systematic review of methods used to conduct decentralised clinical trials.British journal of clinical pharmacology · 2022Pooled it
- Factors influencing harmonized health data collection, sharing and linkage in Denmark and Switzerland: A systematic review.PloS one · 2019Pooled it
- Trial
- Precision Recruitment and Engagement of Individuals at Risk for Diabetes and Hypertension in Clinical Trials (PREDHICT): A Randomized Trial for an E-Persuasive Mobile Application to Inform Decision Making about Clinical Trials.International journal of environmental research and public health · 2023Trial
- Feasibility of a hybrid clinical trial for respiratory virus detection in toddlers during the influenza season.BMC medical research methodology · 2021Trial
- Different corticosteroid induction regimens in children and young people with juvenile idiopathic arthritis: the SIRJIA mixed-methods feasibility study.Health technology assessment (Winchester, England) · 2020Trial
- Article
- Why and how do we perform physical examination(s) in clinical trials? A use case of drug intervention trials in type 2 diabetes mellitus.British journal of clinical pharmacology · 2026Article
- Trial characteristics, methods and reported challenges of decentralised clinical trials: a scoping review.BMJ open · 2025Article
- Do people prefer to take part in a clinical trial from home or come to site? A discrete choice experiment in type 2 diabetes mellitus.BMJ open · 2025Article
- Examining the Association Between DCT Solutions Use and Participant Diversity in Clinical Trials.Therapeutic innovation & regulatory science · 2025Article
- Decentralized Clinical Trials in Pediatrics: Is Italy Ready?Journal of clinical medicine · 2025Article
- Adaptation of Clinical Research Staff to Decentralized Clinical Trials and Impacts on the Patient-Centered Experience: Qualitative Interview Study.Journal of medical Internet research · 2025Article
- Impact of the COVID-19 Pandemic Mitigation Strategies on Cancer Treatment Trials: A Meta-Analysis of Industry and National Cancer Institute Studies.JCO oncology advances · 2025Article
- Diversity in decentralized clinical trials: prioritizing inclusion of underrepresented groups.BMC medical ethics · 2025Review
- Sample-size determination for decentralized clinical trials.International journal of epidemiology · 2025Article
- What motivates people with type 2 diabetes mellitus to participate in clinical trials from home?Clinical and translational science · 2024Article
- Telehealth mindful exercise for people with knee osteoarthritis: A decentralized feasibility randomized controlled trial.Osteoarthritis and cartilage open · 2024Article
- Narrative review of telemedicine applications in decentralized research.Journal of clinical and translational science · 2024Review
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Clinical trials are slow and costly, built around the research centers that study local participants. Building clinical trials around patients in their homes and community through remote visits and monitoring could enhance recruitment and increase convenience for participants. This study evaluated different trial settings, a decentralized arm via telemedicine center (virtual study conduct), a conventional arm via health clinic (onsite study conduct) and a mixed model arm. Acute low-back pain patients (20-65 years) were recruited to this non-interventional trial in Switzerland. The study consisted of a screening period and a 2-week data collection period using direct data capture (eSource), electronic informed consent form (eICF), electronic diary (eDiary) and wearable actigraphy sensor. A higher number of patients were enrolled in the decentralized arm (N = 18) compared to the conventional arm (N = 5) and none in the mixed model arm. The decentralized arm consisted of a diverse population with increased participation from rural areas. In the decentralized arm 89% of enrolled patients completed the study compared to 60% in the conventional arm. All the patients reported satisfaction with the use of eICF, eDiary and remote visits; whereas patients reported a lower level of satisfaction with the wearable sensor. The decentralized setting was operationally feasible and well accepted by patients. Faster recruitment and improved access to patients was observed in the decentralized arm. This study supports broader adoption of the decentralized model in clinical trials, though further investigations in larger interventional trials are needed to confirm the benefits from this patient-centric approach.
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