ReviewClinical and translational science2025
Decentralized Clinical Trials in the Era of Real-World Evidence: A Statistical Perspective.
Review in Clinical and translational science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 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
13 citing papers in PubMed.
- Optimising clinical trial design choices in inflammatory bowel disease.BMJ open gastroenterology · 2026Review
- Advancing clinical trials for rare renal cell carcinoma subtypes: Consensus statements from the International Kidney Cancer Symposium North America 2025 think tank.Urologic oncology · 2026Article
- Exercise as a Programmable Regulator of Mitophagy Sensitivity in Aging Muscle and Age-Related Disease.IUBMB life · 2026Review
- Addressing the Key Challenges of Decentralized Clinical Trials in Europe: Multistakeholder Perspective Delphi Study.Journal of medical Internet research · 2026Article
- Ethical Challenges and Considerations in Decentralized Clinical Trials (DCTs): Insights from a Scoping Review.Therapeutic innovation & regulatory science · 2026Article
- Perspectives in educating molecular pathologists on liquid biopsy: Toward integrative, equitable, and decentralized precision oncology.Molecular oncology · 2026Review
- Bringing Trial Activities to Participants-The Trials@Home RADIAL Proof-of-Concept Trial Investigating Decentralization of Trials.Clinical pharmacology and therapeutics · 2025Article
- Operationalizing Decentralized Clinical Trials: Technology Insights from the Trials@Home RADIAL Proof-of-Concept Trial.Clinical pharmacology and therapeutics · 2025Article
- Selecting and Preparing Clinical Sites for the Successful Conduct of Decentralized Clinical Trial Activities-Findings From the Trials@Home RADIAL Proof-of-Concept Trial.Clinical pharmacology and therapeutics · 2025Article
- Decentralized Clinical Trials: Governance, Ethics and Medico-Legal Issues for the New Paradigm of Research with a Focus on Cardiovascular Field.Medical sciences (Basel, Switzerland) · 2025Review
- Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health.Sensors (Basel, Switzerland) · 2025Review
- The Changing Landscape of Heart Failure Drug Clinical Trials in China, 2013-2023.Drug design, development and therapy · 2025Review
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
There has been a growing trend that activities relating to clinical trials take place at locations other than traditional trial sites (hence decentralized clinical trials or DCTs), some of which are at settings of real-world clinical practice. Although there are numerous benefits of DCTs, this also brings some implications on a number of issues relating to the design, conduct, and analysis of DCTs. The Real-World Evidence Scientific Working Group of the American Statistical Association Biopharmaceutical Section has been reviewing the field of DCTs and provides in this paper considerations for decentralized trials from a statistical perspective. This paper first discusses selected critical decentralized elements that may have statistical implications on the trial and then summarizes regulatory guidance, framework, and initiatives on DCTs. More discussions are presented by focusing on the design (including construction of estimand), implementation, statistical analysis plan (including missing data handling), and reporting of safety events. Some additional considerations (e.g., ethical considerations, technology infrastructure, study oversight, data security and privacy, and regulatory compliance) are also briefly discussed. This paper is intended to provide statistical considerations for decentralized trials of medical products to support regulatory decision-making.
Indexed as
Identifiers
What Socratic 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 Socratic graph.