{"entity":{"id":"idea-tr1-open-protocol-and-sap-library","kind":"idea","name":"Open-source protocol and statistical analysis plan templates with runnable code","aka":[],"tldr":"Every trial writes its protocol and analysis plan from scratch. A shared library of well-written templates and ready-to-run analysis code would let teams start from the best version rather than a blank page.","summary":"A curated public repository of oncology protocol templates (by design type), statistical analysis plans with executable code (R/Python) for standard endpoints, adaptive designs and estimands, and eligibility criterion libraries with computable definitions. Maintained by cooperative groups and statistical societies with version control and peer review, building on the TransCelerate common protocol template and CDISC standards.","asOf":"2026-09-08","links":[{"label":"TransCelerate BioPharma","url":"https://www.transceleratebiopharmainc.com/"},{"label":"CDISC","url":"https://www.cdisc.org/"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["curie-nki-eortc"],"institutions":["nci"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-trial-design","b-knowledge-diffusion","b-reproducibility"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Teams using the library will produce protocols and SAPs in half the time, with fewer regulator queries, and analyses will be more reproducible across trials.","rationale":"Open-source infrastructure accelerated software and genomics; protocol writing remains artisanal. Reuse also propagates good practice (broad eligibility, tolerability estimands) by default.","test":"Release the library and compare protocol development time and query counts for cooperative-group trials that use it versus those that do not over two years.","maturity":"speculative","actor":"research","cost":"small","horizonYears":2},"route":"/ideas/idea-tr1-open-protocol-and-sap-library/","neighbours":{"company":[{"id":"curie-nki-eortc","kind":"company","name":"EORTC","route":"/companies/curie-nki-eortc/"}],"institution":[{"id":"nci","kind":"institution","name":"National Cancer Institute (NIH)","route":"/institutions/nci/"}],"bottleneck":[{"id":"b-knowledge-diffusion","kind":"bottleneck","name":"Knowledge reaches practice too slowly","route":"/bottlenecks/b-knowledge-diffusion/"},{"id":"b-reproducibility","kind":"bottleneck","name":"Preclinical results do not reproduce","route":"/bottlenecks/b-reproducibility/"},{"id":"b-trial-design","kind":"bottleneck","name":"Trial design, endpoints and cost","route":"/bottlenecks/b-trial-design/"}]}}