Study Metrics
Total Sample
1886
Treatment Group
462
Control Group
1424
Covariates
18
PICO Comparisons
1
Quality Indicators
Transparency
High
DAG Usage
No
QBA Performed
No
Study Information
| First Author: | Merola |
| Publication Year: | 2022 |
| DOI: | https://doi.org/10.2147/CLEP.S373291 |
| Preprint: | No preprint |
Institution & Funding
| Institutions: | Brigham and Women's Hospital, Harvard Medical School, Harvard TH Chan School of Public Health, Harvard Pilgrim Healthcare Institute, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical School, Massachusetts General Hospital, Ontada |
| Funding: | Declared: NGO |
| Funding Institutions: | This project was funded by an Innovation in Regulatory Science Award from the Burroughs Wellcome Fund (#1020021). |
Study Context
| Disease: | Breast cancer |
| Disease Category: | Oncology |
| Data Type: | Electronic Health Records |
| Number of Data Sources: | 1 |
| Geography: | US |
| Eligible Sample: | 1886.0 |
Analytical Methods
| Missing Data Method: | Multiple imputation |
| Matching Method: | Stratification |
| Analysis Method: | Cox PH |
Quality Methods
Directed Acyclic Graph (DAG)
Not Used
Quantitative Bias Analysis (QBA)
Not Performed
Target Trial Information
| Target Trial Name: | PARSIFAL |
| Registration Number: | NCT02491983 |
| Target Trial DOI: | https://doi.org/10.1001/jamaoncol.2021.4301 |
TTE vs RCT Comparisons
Detailed comparison between Target Trial Emulation results and corresponding Randomized Controlled Trial outcomes.
Overall survival
PARSIFAL
HR
Efficacy
Population
Women ≥18 years old with metastatic breast cancer
Intervention
Fulvestrant + Palbociclib
Comparison
Letrozole + Palbociclib
Outcome
Overall survival
RCT Result
1.00
95% CI: [0.68, 1.48]
vs
TTE Result
1.07
95% CI: [0.86, 1.35]
Concordance Assessment
Confidence Interval Overlap:
Yes
CIs overlap, suggesting concordance
CIs overlap, suggesting concordance
Direction Agreement:
Different Direction
Different conclusions
Different conclusions
Transparency Indicators
Protocol Registration
Available
Data Sharing
Not Available
Code Sharing
Not Available
Overall Transparency Score:
High Transparency - This study meets good transparency standards.
Conflicts & Funding
| Conflicts of Interest: | Declared: Financial |
| COI Institutions: | Aetion Inc, McKesson Corporation, Boehringer Ingelheim, JAMA, GRAIL, Dana-Farber Cancer Institute |
| Funding Source: | Declared: NGO |
| Funding Institutions: | This project was funded by an Innovation in Regulatory Science Award from the Burroughs Wellcome Fund (#1020021). |