mondotwin/mondotwin-researcher

Draft inclusion and exclusion criteria for a clinical trial from the criteria of comparable registered trials, and propose concomitant-medication exclusions from what those trials prohibit and from the investigational drug's likely interactions with background and commonly co-prescribed drugs. Use when the user asks to write, draft, compare, tighten or broaden eligibility criteria, inclusion/exclusion criteria, or prohibited and restricted medications for a study.

Summarise which primary and key secondary endpoints comparable registered trials used and at which time points, and draft the estimand for a trial objective following ICH E9(R1) (treatment, population, variable, intercurrent events with their strategies, population-level summary). Use when the user is choosing or justifying a primary or secondary endpoint, asks what similar trials measured and when, or asks to define, check or write an estimand or an intercurrent-event strategy.

Report which primary endpoints the registered trials of an indication used and how often each succeeded or failed, by phase, and which control arms and active comparators those trials used and how they fared, from mondoTWIN's twin. Use when the user asks which endpoints work or have succeeded for a disease, for endpoint precedent or success rates by endpoint, what primary endpoint a phase 3 should use, which comparator or control arm trials in the indication used, the standard-of-care comparator, placebo versus active comparator, or what trials in an indication have measured. Descriptive precedent, not a prediction.

Answer a question about ICH or FDA regulatory guidance with the exact passage quoted, the guideline id and the section. Use when the user asks what ICH (for example E6(R3), E8(R1), E9(R1), E10, M11, the Q series) or FDA guidance says about a topic, wants the source or exact wording of a regulatory expectation, or wants to check a statement against the guidance.

Review a draft clinical trial protocol or synopsis section (objectives, endpoints, eligibility criteria, sample size rationale, schedule of activities) against comparable registered trials and ICH E6(R3), E8(R1), E9(R1) and M11, and return numbered, reasoned changes, each backed by trial registry ids or a quoted guideline passage and marked "to validate". Use when the user pastes or describes part of a protocol and asks for a review, critique, gap check, improvements, or consistency with ICH or with what similar trials did.

Benchmark a planned or existing clinical trial against comparable registered trials (ClinicalTrials.gov, EU CTR/CTIS, ISRCTN, ANZCTR, UMIN) and return a table with registry id and link, phase, status, enrolment, primary endpoint and time frame, key eligibility criteria and stop reason. Use when the user asks for similar, comparable, competing or precedent trials, a trial landscape for a drug, indication or design, or "what has been done before" for a study they are planning.