ReviewJournal of clinical and translational science2023
Guidance on interim analysis methods in clinical trials.
Review in Journal of clinical and translational science, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 39 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.
The Effect of a Novel Joint Distraction Knee Orthosis for Treating Medial Knee Osteoarthritis
Clinical Assessment of Respiratory Events for Kids: Integrating Diagnostics and Stewardship
Who cites it
39 citing papers in PubMed.
- A remote intervention to improve medication nonadherence guided by a marker of risk derived from the electronic health records of adolescent transplant recipients.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2026Trial
- Trial
- Effect of desflurane versus propofol on perioperative neurocognitive disorders in older adults undergoing major urological surgery: a randomized trial.BMC geriatrics · 2026Trial
- Trial
- No effect of tetracosactide for treatment of postdural puncture headaches in parturient women: a double-blind randomised controlled clinical trial.British journal of anaesthesia · 2025Trial
- Systemic and cerebro-cardiac biomarkers following traumatic brain injury: an interim analysis of randomized controlled clinical trial of early administration of beta blockers.Scientific reports · 2024Trial
- Biomarker-guided acute kidney injury risk assessment under liberal versus restrictive fluid therapy - the prospective-randomized MAYDAY-trial.Scientific reports · 2024Trial
- Randomized clinical trial on safety of the natriuretic peptide ularitide as treatment of refractory cirrhotic ascites.Hepatology communications · 2024Trial
- Analytic Misjudgment of Drug Safety Evidence and Causality: From the Prosecutor's Fallacy and Simpson's Paradox to Artificial Intelligence.Drug safety · 2026Review
- Article
- Rationale for incorporating short-term endpoints in interim futility analysis of phase 3 oncology trials: a simulation study.BMC medical research methodology · 2026Article
- The added value of Bayesian interim analysis in randomized phase II and phase III clinical trials in hemato-oncology.Haematologica · 2026Article
- Clinical Trial Simulation: Planning With the OCTAVE Framework, Implementation and Validation Principles.Statistics in medicine · 2026Article
- Infrared Kinesiology Tape Increases Skin Temperature and Red Blood Cell Flux at Rest.International journal of sports physical therapy · 2026Article
- Comments on "Low-Dose Morphine Intrathecal Analgesia in Elderly Patients with Hip Fracture Undergoing Single Spinal Anesthesia: A Randomized Controlled Trial" [Response to Letter].Local and regional anesthesia · 2026Article
- The benefits of PCNL combined with ureterorenoscopy compared to isolated PCNL in urolithiasis (PRECISE): a multicentre randomised controlled trial protocol.BJU international · 2026Article
- From feedback to action: a process evaluation of implementation strategies for sepsis bundles in emergency departments.Frontiers in medicine · 2026Article
- Effectiveness and cost-effectiveness of an online transdiagnostic positive psychology intervention for patients awaiting mental health treatment and their loved ones: study protocol.BMC psychology · 2025Article
- Bayesian interim analysis and efficiency of phase III randomized trials.British journal of cancer · 2025Article
- Practical guidance for conducting high-quality and rapid interim analyses in adaptive clinical trials.BMC medicine · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
Abstract
Interim analyses in clinical trials can take on a multitude of forms. They are often used to guide Data and Safety Monitoring Board (DSMB) recommendations to study teams regarding recruitment targets for large, later-phase clinical trials. As collaborative biostatisticians working and teaching in multiple fields of research and across a broad array of trial phases, we note the large heterogeneity and confusion surrounding interim analyses in clinical trials. Thus, in this paper, we aim to provide a general overview and guidance on interim analyses for a nonstatistical audience. We explain each of the following types of interim analyses: efficacy, futility, safety, and sample size re-estimation, and we provide the reader with reasoning, examples, and implications for each. We emphasize that while the types of interim analyses employed may differ depending on the nature of the study, we would always recommend prespecification of the interim analytic plan to the extent possible with risk mitigation and trial integrity remaining a priority. Finally, we posit that interim analyses should be used as tools to help the DSMB make informed decisions in the context of the overarching study. They should generally not be deemed binding, and they should not be reviewed in isolation.
Indexed as
Identifiers
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.