Trial reportClinical trials (London, England)2022
Incorporating estimands into clinical trial statistical analysis plans.
Trial report in Clinical trials (London, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
What it found
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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.
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
20 citing papers in PubMed, 38 citations in OpenAlex.
- Trial
- Trial
- Pitavastatin to Prevent Cardiovascular Disease in HIV Infection.The New England journal of medicine · 2023 · on this mapTrial
- WIse CHoices in the ICU (WICH-ICU): Protocol and Statistical Analysis Plan for a Stepped-Wedge Cluster Randomized Trial of Choosing Wisely Interventions in Swedish Intensive Care Units.Acta anaesthesiologica Scandinavica · 2026Article
- Defining estimands in anaesthesia clinical trials: a scoping review and framework.British journal of anaesthesia · 2026Article
- Telitacicept for pediatric Henoch-Schönlein purpura nephritis: analytical populations and safety monitoring.Clinical rheumatology · 2026Article
- Review
- Review
- Article
- Mindfulness-Based Cognitive Therapy for Life (MBCT-L) Versus Stress Reduction Psychoeducation (SRP) for the Improvement of Mental Well-Being in Health Care and Other Public Sector Staff: Protocol for the Well at Work Randomized Controlled Trial.JMIR research protocols · 2025Article
- An Example to Illustrate Randomized Trial Estimands and Estimators.The American statistician · 2025Article
- Statistical methods for clinical trials interrupted by the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) pandemic: A review.Statistical methods in medical research · 2024Review
- Making causal inferences from transactional data: A narrative review of opportunities and challenges when implementing the target trial framework.The Journal of international medical research · 2024Review
- Immunogenicity, safety, and reactogenicity of a half- versus full-dose BNT162b2 (Pfizer-BioNTech) booster following a two-dose ChAdOx1 nCoV-19, BBIBP-CorV, or Gam-COVID-Vac priming schedule in Mongolia: a randomised, controlled, non-inferiority trial.The Lancet regional health. Western Pacific · 2024Article
- Design and analysis considerations for early phase clinical trials in hepatitis B (HBV) cure research: the ACTG A5394 study in persons with both HIV and HBV.Journal of virus eradication · 2023Article
- Public Health Impacts of Vaccines for COVID-19 and Beyond: Opportunities to Overcome Technical and Regulatory Barriers for Randomized Trials.American journal of public health · 2023Article
- Evolving a national clinical trials learning health system.Learning health systems · 2023Article
- Article
- The Use of Estimands in the Design and Analysis of Comparative Effectiveness Trials: The PEPPER Trial.JB & JS open accessArticle
- Current developments of the estimand concept.Pharmaceutical statisticsArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 1 institution in 1 country.
Funding
Abstract
backgroundInternational Council for Harmonisation (ICH) E9
methodsA table format was used to create a template for inclusion in SAPs that satisfies ICH E9 (R1) guidance to align statistical analysis to the estimand. The template provides a consistent structure for presentation of estimands and the associated analysis, and is applicable to a wide range of trial designs. We illustrate use of the template with a hypothetical clinical trial in HIV-1.
resultsThe estimand-to-analysis table template starts with the study objective describing the clinical question of interest as written in the trial protocol. The remainder of the table describes each attribute of the estimand (treatment, target population, variable, intercurrent events, and population-level summary) in the left column (ESTIMAND), while the right column describes how each attribute will be handled using the data collected in the clinical trial (ANALYSIS). The template was applied to a hypothetical, early-phase single-arm trial, modeled after a pediatric trial in HIV, where the objective was to determine the safety of a new antiretroviral drug as part of a combination antiretroviral treatment regimen in the pediatric population. Three intercurrent events were illustrated in the table: death, premature treatment discontinuation before 24 weeks, and pregnancy. An estimand-to-analysis table from a grant application that addresses the primary objective of a placebo-controlled randomized trial is also presented to demonstrate an alternative usage.
conclusionWe found the template to be useful in study design, providing a snapshot of the objective, target population, potential intercurrent events, analysis plan, and considerations for missing data in one place and facilitating discussion among stakeholders. The proposed standardized presentation of estimand attributes and analysis considerations in SAPs will provide guidance to SAP authors and consistency across studies to facilitate reviews.
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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.