Highly Efficient Clinical Trials Simulator (HECT): Software application for planning and simulating platform adaptive trials
Why this work is in the frame
A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.
Bibliographic record
Abstract
<ns4:p> <ns4:bold>Background:</ns4:bold> Adaptive designs and platform designs are among two common clinical trial innovations that are increasingly being used to manage medical intervention portfolios and attain faster regulatory approvals. Planning of adaptive and platform trials necessitate simulations to understand how a set of adaptation rules will likely affect the properties of the trial. Clinical trial simulations, however, remain a black box to many clinical trials researchers who are not statisticians. </ns4:p> <ns4:p> <ns4:bold>Results:</ns4:bold> In this article we introduce a simple intuitive open-source browser-based clinical trial simulator for planning adaptive and platform trials. The software application is implemented in <ns4:italic>RShiny</ns4:italic> and features a graphical user interface that allows the user to set key clinical trial parameters and explore multiple scenarios such as varying treatment effects, control response and adherence, as well as number of interim looks and adaptation rules. The software provides simulation options for a number of designs such as dropping treatment arms for futility, adding a new treatment arm (i.e., platform design), and stopping a trial early based on superiority. All available adaptations are based on underlying Bayesian probabilities. The software comes with a number of graphical outputs to examine properties of individual simulated trials. The main output is a comparison of trial design performance across several simulations, graphically summarizing type I error (false positive risk), power, and expected cost/time to completion of the considered designs. </ns4:p> <ns4:p> <ns4:bold>Conclusion:</ns4:bold> We have developed and validated an intuitive highly efficient clinical trial simulator for planning of clinical trials. The software is open-source and caters to clinical trial investigators who do not have the statistical capacity for trial simulations available in their team. The software can be accessed via any web browser via the following link: <ns4:italic>https://mtek.shinyapps.io/hect/</ns4:italic> </ns4:p>
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Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.377 | 0.857 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.007 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.002 | 0.007 |
| Research integrity | 0.002 | 0.004 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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 it