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IPAK-EDU · RESEARCH FACILITATION · MONTE CARLO
Clinical Trial Failure Simulator
Upload a trial proposal and every patient gets simulated through screening, randomization, adherence, dropout, interim looks, DSMB review, supply shocks and budget burn. The output is the emergent Expected Trial Failure Probability (ETFP): how likely the trial is to fail to deliver a correct, conclusive answer, whatever the true effect turns out to be.
1 · Proposal
PDF, Word, PowerPoint, Excel, CSV, text, Markdown, RTF, OpenDocument, HTML or a .zip of any of these. Select several files at once to combine them.
…or paste proposal text
Extraction report
Fields marked E came from the proposal (hover for the source quote). Fields marked A are assumptions, so check them first.
2 · Trial model
Upload a trial proposal above. Its parameters fill in here automatically, and the simulation runs on its own.
Arms (row 1 = control. Effect = RR/HR for binary/TTE, or mean difference in the beneficial direction for continuous. Effect SD is on the log scale for ratios.)
| ARM | ALLOCATION | EFFECT (MEAN) | EFFECT SD |
|---|
Which failures count toward ETFP
Model JSON (copy / paste / edit)
3 · Run
Expected Trial Failure Probability
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Synopsis of the failure analysis
Weak-point analysis
Written by Claude from the full simulation report once all runs finish.
How each simulated trial ended
Green outcomes are correct, conclusive answers; the rest are failures. Operational trouble is simulated as a mechanism, not counted as a flag: a trial that runs out of money stops and analyses what it has (or is abandoned, if you choose), and a trial that enrolls too few patients is analysed with whoever enrolled. That trouble therefore shows up here as an inconclusive or wrong answer.
What drives failure: conditions present in failed trials
For each condition: how often it occurs, the failure rate with and without it, and the difference with a 95% interval. “Attributable” is the share of all simulated trials whose failure goes with the condition (prevalence × difference). These are associations inside the model, ranked by attributable share.
Weak points: sensitivity tornado
Each input is moved ±20% with common random numbers. The longest bars are the assumptions your ETFP depends on most.
Computing…
Hedges: what buys down failure, and which ones backfire
Each mitigation is applied on its own. ΔETFP below zero helps. Cost is the added expected spend as a % of budget. A hedge that raises the probability of budget failure past its benefit gets flagged as backfiring.
Computing…
Break points
Computing…
Resource distributions
Emergent drivers
Correlation between each simulated condition and failure, across trials. It shows what tends to precede failure inside this model. It does not establish causation outside the model.
Redesign the trial to succeed
Claude redesigns the trial against this assessment and returns a new title, an executive abstract and a parameter table. Run the redesign through the simulator for a new assessment, and repeat until the trial is viable. The scientific question is locked: the assumed true effect, alpha, MCID, endpoint and the failure definitions cannot be changed, so a redesign can’t succeed by assuming a bigger effect.
Executive abstract
What changed
Full parameter table for this redesign
Model notes (gen 11): every design shares one operations model — regulatory delay, site activation, screening, consent, supply interruptions and budget burn, with money running out stopping the trial (which then analyses what it has or is abandoned). Design modules: parallel superiority, non-inferiority and equivalence (frequentist group-sequential or Bayesian posterior thresholds); cluster-randomized (cluster-level t-test); stepped-wedge (cluster and period fixed effects on cluster-period means); crossover and N-of-1 (within-patient differences, carryover, period effect); factorial (marginal main effects, optional interaction); multi-arm with arm dropping and patient reallocation, and seamless II/III selection; non-randomized comparisons with drawn confounding bias; single-arm exact or Simon tests against a drifting benchmark; basket trials; dose-finding by 3+3, BOIN or CRM with an optional expansion cohort; and diagnostic accuracy with partial-verification bias. Safety stops are judged against drawn true SAE rates. Dropout is MCAR unless MNAR is chosen. Sensitivity and hedge comparisons are paired on the same seeds and carry 95% intervals. Budget is in your own units.