ArticleContemporary clinical trials communications2022
Effects of dose change on the success of clinical trials.
Article in Contemporary clinical trials communications, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 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
11 citing papers in PubMed, 12 citations in OpenAlex.
- Statistical inference for saved time based on disease progression curves in Alzheimer's disease research.Contemporary clinical trials communications · 2026Article
- A review of evidence supporting amyloid beta reduction as a surrogate endpoint in Alzheimer's disease.The journal of prevention of Alzheimer's disease · 2026Review
- Testing disease progression under the proportional reduction in decline in Alzheimer's disease studies.Journal of applied statistics · 2026Article
- Insights into the adoption of innovative clinical trials across therapeutic areas using clinical trials registry data and large Language models.Scientific reports · 2025Article
- Disease progression trajectory curves to estimate saved time in Alzheimer's disease trials.Contemporary clinical trials · 2025Article
- Sample size determination for a study with variable follow-up time.Journal of biopharmaceutical statistics · 2025Article
- Blood biomarkers as surrogate endpoints in Alzheimer's disease research.Frontiers in aging neuroscience · 2025Article
- Sample size calculation for the sequential parallel comparison design with binary endpoint using exact methods.Journal of applied statistics · 2025Article
- Response adaptive randomization design for a two-stage study with binary response.Journal of biopharmaceutical statistics · 2023Article
- Continuity corrected Wilson interval for the difference of two independent proportions.Journal of statistical theory and applications : JSTA · 2023Article
- Monte Carlo cross-validation for a study with binary outcome and limited sample size.BMC medical informatics and decision making · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 3 institutions in 1 country.
Funding
Abstract
The search for disease modifying therapies in Alzheimers disease (AD) has recently led to promising results but also revealed design issues in clinical trials themselves. Of particular importance is the potential statistical challenges that can arise when dosages change after an interim analysis, which is not uncommon in contemporary AD trials. Following the recent Aducanumab trials, we sought to study the implications of dose changes on the statistical power of an AD trial. We conducted extensive simulations to calculate statistical power when the relationship between treatment effect size and time is linear or non-linear, and the investigated drug has delayed treatment effect or not. Statistical power depends on many design factors including the dose change time, correlation, population homogeneity, and treatment effect time. We recommend that researchers conduct simulation studies at the interim analysis to justify the modified sample size and/or follow-up time modification meanwhile the type I and II error rates are controlled.
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.