Act 4 · Apply · F2.1
Protocol tool
From an indication or a published trial to a synopsis, simulations and a design report.
Sample values. Synthetic study, not real patients.
Demo role: Viewer: reads only. Switch. Roles are a demo switch, not sign-in.
Start from an indication
Switch to the analyst or biostatistician role on Demo control to build a design.
Endpoint, arms, criteria and the effect to plan for are planning starting points, labelled assumed.
Start from a published trial
The design facts come from the paper, each marked checked or not yet checked against it. No protocol text is copied. The question is how that design would run in Vietnam.
The published trials in the library
| Trial | Primary endpoint | Published effect | Control arm | Enrolled | Source |
|---|---|---|---|---|---|
| FLAURA Osimertinib against gefitinib or erlotinib, first line, EGFR-mutated advanced NSCLC | Progression-free survival time to event | 0.46 (as stated) Assumed checked | 10.2 months (as stated) Assumed checked | 556 (as stated) Assumed not yet checked | Soria et al., N Engl J Med 2018 (FLAURA) NCT02296125 not yet checked |
| KEYNOTE-024 Pembrolizumab against platinum chemotherapy, first line, advanced NSCLC with PD-L1 on at least half of tumour cells | Progression-free survival time to event | 0.50 (as stated) Assumed checked | 6.00 months (as stated) Assumed checked | 305 (as stated) Assumed checked | Reck et al., N Engl J Med 2016 (KEYNOTE-024) NCT02142738 checked |
| KEYNOTE-189 Pembrolizumab or placebo added to pemetrexed and platinum, first line, metastatic nonsquamous NSCLC | Progression-free survival time to event | 0.52 (as stated) Assumed checked | 4.90 months (as stated) Assumed checked | 616 (as stated) Assumed checked | Gandhi et al., N Engl J Med 2018 (KEYNOTE-189) NCT02578680 not yet checked |
| CHANCE Clopidogrel plus aspirin against aspirin alone within 24 hours of minor stroke or high-risk TIA | New stroke within 90 days binary | −3.5% (as stated) Assumed not yet checked | 11.7% (as stated) Assumed not yet checked | 5,170 (as stated) Assumed checked | Wang et al., N Engl J Med 2013;369:11-19 (CHANCE) NCT00979589 checked |
platform_zone/design/library/published_trials.json. A figure marked not yet checked must be checked against the paper before a real report uses it.
Designs built with the tool
None yet.