Related Experiment Video
Updated: May 31, 2026
06:03
Integrating Augmented Reality Tools in Breast Cancer Related Lymphedema Prognostication and Diagnosis
Published on: February 6, 2020
Directly comparing randomized and real-world controls in adjuvant breast cancer
Brigham Walker1, Marley Boyd2, Michelle Silver3
1Department of Health Policy and Management, Tulane University Celia Scott Weatherhead School of Public Health, LA 70112, USA.
Journal of Comparative Effectiveness Research
|May 29, 2026
Summary
Real-world data can serve as a synthetic control arm in early breast cancer trials. This study found no significant differences in disease-free survival between real-world and randomized controlled trial control groups.
Area of Science:
- Oncology
- Clinical Trials
- Health Informatics
Background:
- Randomized controlled trials (RCTs) are the gold standard for evaluating cancer treatments.
- Real-world (RW) data offers a valuable alternative or supplement to RCTs.
- Utilizing RW data can potentially streamline early breast cancer research.
Purpose of the Study:
- To directly compare contemporaneous RW and RCT control arms in early breast cancer.
- To assess the feasibility of using RW controls in this patient population.
- To evaluate the efficacy of adjuvant docetaxel, doxorubicin, and cyclophosphamide treatment.
Main Methods:
- Included women with HER2-negative high-risk breast cancer receiving specific adjuvant chemotherapy.
- Extracted structured data from the iKnowMed electronic medical record system.
- Employed propensity scores for baseline characteristic balancing and Kaplan-Meier analysis.
Main Results:
- A total of 306 patients were analyzed (153 per arm).
- Propensity score matching successfully balanced covariates between RW and RCT cohorts.
- Kaplan-Meier analysis showed no significant difference in disease-free survival between the arms (p=0.98).
Conclusions:
- RW data demonstrated feasibility as a synthetic control arm in this early breast cancer setting.
- The findings support the potential use of RW data in future clinical trial designs.
- Further research is needed to address limitations, such as reliance on structured data only.
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