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A Swapping Method for Average Treatment Effect Estimation
Proposal
1528
Title of Proposed Research
A Swapping Method for Average Treatment Effect Estimation
Lead Researcher
Bimal Sinha
Affiliation
Statistics, the University of Maryland at Baltimore County (UMBC)
Funding Source
None
Potential Conflicts of Interest
None
Data Sharing Agreement Date
6 Sep 2016
Lay Summary
Accurate estimate of treatment effect is vital to clinical studies. A randomized controlled trial (RCT) is the gold standard to reduce bias when testing a new treatment. The people participating in the trial are randomly allocated to either the group receiving the treatment or to a group receiving the control. Such a randomization process minimises the selection bias and therefore allows the researchers to determine any effect differences between the treatment and the control groups. However, the imbalance in covariates such as age, gender, and laboratory measurements can exist in flawed randomized trials due to non-random dropouts and interruption, and non-randomized studies such as open label or single-blind designs. Although methods such as propensity score based methods can remedy the issue, the imbalance continues to be one of major issues in clinical studies.
We propose a swapping method to achieve the balance. We classify all patients into subclasses based on discrete covariates such as gender. Within each subclass, we then estimate the average treatment effect based on the principle of choosing a better model between the treatment and baseline groups. The simulation studies indicate that our method provides more stable estimates than traditional methods. The proposed datasets are for non-randomized studies. They are helpful to illustrate the public the importance of correcting the bias and therefore providing more reliable and accurate estimate of treatment effects in clinical studies. We can provide a powerful tool that will be published and distributed to the community.
Study Data Provided
[{ "PostingID": 2574, "Title": "ROCHE-BO21977", "Description": "A randomized, Multicenter, Phase III Open-Label study of the efficacy and safety of Trastuzumab-MCC-DM1 vs. Capecitabine + Lapatinib in patients with HER2-Positive locally advanced or metastic breast cancer who have received prior Trastuzumab-based therapy." },{ "PostingID": 3125, "Title": "GSK-GLP108486", "Description": "A Randomized, Open-Label, Active-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Albiglutide Administered in Combination With Insulin Glargine as Compared with the Combination of Insulin Glargine and Preprandial Lispro Insulin in Subjects With Type 2 Diabetes Mellitus" },{ "PostingID": 3358, "Title": "ROCHE-BO16216", "Description": "A randomized, open-label study of the effect of Herceptin plus Arimidex compared with Arimidex alone on progression-free survival in patients with HER2-positive and hormone-receptor positive metastatic breast cancer" },{ "PostingID": 3826, "Title": "LILLY-H9X-MC-GBDE", "Description": "A Randomized, Open-Label, Parallel-Arm Study Comparing the Effect of Once-Weekly Dulaglutide with Once-Daily Liraglutide in Patients with Type 2 Diabetes (AWARD 6: Assessment of Weekly AdministRation of LY2189265 in Diabetes-6)" }]
Statistical Analysis Plan
The proposed procedure generates the average treatment effect using a technique that infuses swapping" of models based on classical regression and meta-analyses procedures. The mean comparison between two groups of treatment and control is carried out after the classification of categorical variables. If non-hypothesis is rejected, the swapping proceeds. The swapping" procedure allows for the imputation of the missing potential outcome Y (1) and Y (0) for units in the control and treatment groups, respectively, while meta-analysis provides a means of combining the effect sizes calculated from each matched group while addressing the issue of homogeneity. We show that the estimated average treatment effect is unbiased, and has much better performance than multiple propensity score based approaches.
Publication Citation
https://www.tci-thaijo.org/index.php/thaistat/article/view/163194/117937
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