ArticleAMIA ... Annual Symposium proceedings. AMIA Symposium2020
Using Real-World Data to Rationalize Clinical Trials Eligibility Criteria Design: A Case Study of Alzheimer's Disease Trials.
Article in AMIA ... Annual Symposium proceedings. AMIA Symposium, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 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
15 citing papers in PubMed.
- Data-driven trial design: use of target trial emulation to evaluate eligibility criteria in asthma and COPD.Frontiers in medicine · 2026Article
- Validity of gold-standard clinical outcome assessments in U.S. Latinx-Hispanic participants enrolled in Alzheimer's disease clinical trials: A literature review.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025Review
- Federated target trial emulation using distributed observational data for treatment effect estimation.NPJ digital medicine · 2025Article
- Federated Target Trial Emulation using Distributed Observational Data for Treatment Effect Estimation.medRxiv : the preprint server for health sciences · 2025Article
- Analysis of eligibility criteria in Alzheimer's and related dementias clinical trials.Scientific reports · 2024Article
- High-throughput target trial emulation for Alzheimer's disease drug repurposing with real-world data.Nature communications · 2023Article
- Real-world data analysis on effectiveness of integrative therapies: A practical guide to study design and data analysis using healthcare databases.Integrative medicine research · 2023Article
- Exploring the Effect of Eligibility Criteria on AD Severity and Severe Adverse Event in Eligible Patients.Proceedings. IEEE International Conference on Healthcare Informatics · 2023Article
- Assess the documentation of cognitive tests and biomarkers in electronic health records via natural language processing for Alzheimer's disease and related dementias.International journal of medical informatics · 2023Article
- Machine learning enabled subgroup analysis with real-world data to inform clinical trial eligibility criteria design.Scientific reports · 2023Article
- Simulating Colorectal Cancer Trials Using Real-World Data.JCO clinical cancer informatics · 2022Article
- Impacts of Eligibility Criteria on Trial Participants' Age in Alzheimer's Disease Clinical Trials.AMIA ... Annual Symposium proceedings. AMIA Symposium · 2022Article
- Influence of Subject-Specific Effects in Longitudinal Modelling of Cognitive Decline in Alzheimer's Disease.Journal of Alzheimer's disease : JAD · 2022Article
- Quantifying representativeness in randomized clinical trials using machine learning fairness metrics.JAMIA open · 2021Article
- Modifiable Barriers for Recruitment and Retention of Older Adults Participants from Underrepresented Minorities in Alzheimer's Disease Research.Journal of Alzheimer's disease : JAD · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
Low trial generalizability is a concern. The Food and Drug Administration had guidance on broadening trial eligibility criteria to enroll underrepresented populations. However, investigators are hesitant to do so because of concerns over patient safety. There is a lack of methods to rationalize criteria design. In this study, we used data from a large research network to assess how adjustments of eligibility criteria can jointly affect generalizability and patient safety (i.e the number of serious adverse events [SAEs]). We first built a model to predict the number of SAEs. Then, leveraging an a priori generalizability assessment algorithm, we assessed the changes in the number of predicted SAEs and the generalizability score, simulating the process of dropping exclusion criteria and increasing the upper limit of continuous eligibility criteria. We argued that broadening of eligibility criteria should balance between potential increases of SAEs and generalizability using donepezil trials as a case study.
Indexed as
Identifiers
33936446PMC8075542What 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.