Augmenting control arms with real-world data for cancer trials: Hybrid control arm methods and considerations
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Summary
A frequentist two-step borrowing method is proposed to construct hybrid control arms and achieves comparable results for power, type 1 error, and effective number of external events borrowed compared to other borrowing methodologies.
- Type
- article
- Published
- 2021-08-16
- Cited by
- 24
- References
- 68
- Access
- Open access
- OpenAlex
- https://openalex.org/W3195798356
- Semantic Scholar
- https://api.semanticscholar.org/CorpusID:237142530
Keywords
Arms control, Control (management), Computer science, Artificial intelligence, Political science
References
- Median follow-up in clinical trials.
- Hierarchical Commensurate and Power Prior Models for Adaptive Incorporation of Historical Information in Clinical Trials
- Designing Premarket Observational Comparative Studies Using Existing Data as Controls: Challenges and Opportunities
- Evaluating water quality using power priors to incorporate historical information
- A weakly informative default prior distribution for logistic and other regression models
- A note on the power prior
- The combination of randomized and historical controls in clinical trials.
- Comparison of error rates in single-arm versus randomized phase II cancer clinical trials.
- Use of historical control data for assessing treatment effects in clinical trials
- Modernizing Eligibility Criteria for Molecularly Driven Trials.
- Beyond Power Calculations
- Constructing inverse probability weights for marginal structural models.
- Robust meta‐analytic‐predictive priors in clinical trials with historical control information
- Predicting Low Accrual in the National Cancer Institute's Cooperative Group Clinical Trials.
- Using Big Data to Emulate a Target Trial When a Randomized Trial Is Not Available.
- Balancing Covariates via Propensity Score Weighting
- Olaratumab and doxorubicin versus doxorubicin alone in soft tissue sarcoma
- Meta-analytic-predictive use of historical variance data for the design and analysis of clinical trials
- Utilizing national and international registries to enhance pre-market medical device regulatory evaluation
- Blinatumomab vs historical standard therapy of adult relapsed/refractory acute lymphoblastic leukemia
Cited by
- Diversity, Equity and Inclusion
- Emulating Randomized Controlled Trials with Hybrid Control Arms in Oncology: A Case Study
- Current Perspectives for External Control Arms in Oncology Clinical Trials: Analysis of EMA approvals 2016-2021.
- Confounding adjustment in the analysis of augmented randomized controlled trial with hybrid control arm
- Considerations for pooling real-world data as a comparator cohort to a single arm trial: a simulation study on assessment of heterogeneity
- Estimation of treatment effects in early-phase randomized clinical trials involving external control data
- Intratumoral therapies in head and neck squamous cell carcinoma: A systematic review and future perspectives.
- Enhancing External Control Arm Analyses through Data Calibration and Hybrid Designs
- Utilization of Real-World Data to Facilitate Clinical Trials for Patients with Lymphoma
- External Controls to Study Treatment Effects in Rare Diseases: Challenges and Future Directions
- Missing data in the eligibility criteria of synthetic controls from real-world data
- Synthetic Data in Healthcare and Drug Development: Definitions, Regulatory Frameworks, Issues
- Applying Bias Correction Methods to Build Hybrid Controls Using Real‐World Patients for a Phase IIb Randomized Controlled Trial of Baricitinib for Rheumatoid Arthritis
- Outcome Regression Methods for Analyzing Hybrid Control Studies: Balancing Bias and Variability
- Augmenting the Control Arm of Randomized Trials by Incorporating Multiple External Data Sources Using Propensity Score Stratification and Data-Driven Mixture Prior
- Augmented two-stage estimation for treatment switching in oncology trials: Leveraging external data for improved precision
- Addressing Non‐Exchangeability in Hybrid Control Studies: A Variable Selection Approach
- Artificial intelligence-generated synthetic data for cancer research and clinical trials.
- External Control Augmentation Increases Estimates Precision for Finerenone plus Sodium-Glucose Cotransporter-2 Inhibitors
- A Model-Robust G-Computation Method for Analyzing Hybrid Control Studies Without Assuming Exchangeability
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