Adaptive clinical trial designs to detect interaction between treatment and a dichotomous biomarker
Bibliographic record
Abstract
Abstract Biomarkers play a crucial role in the design and analysis of clinical trials for personalized medicine. One major goal of these trials is to derive an optimal treatment scheme based on each patient's biomarker level. Although completely randomized trials may be employed, a more efficient design can be attained when patients are adaptively allocated to different treatments throughout the trial using biomarker information. Therefore, we propose a new adaptive allocation method based on using multiple regression models to study treatment–biomarker interactions. We show that this perspective simplifies the derivation of optimal allocations. Moreover, when implemented in real clinical trials, our method can consolidate all the covariates which may not be related to the treatment–biomarker interaction for a joint analysis. Our general idea can be applied to diverse models to derive optimal allocations. Simulation results show that both the optimal allocation and the proposed design can lead to a more efficient trial. The Canadian Journal of Statistics 41: 525–539; 2013 © 2013 Statistical Society of Canada
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.211 | 0.291 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 0.002 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.001 | 0.004 |
| Scholarly communication | 0.002 | 0.004 |
| Open science | 0.003 | 0.004 |
| Research integrity | 0.004 | 0.006 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".