「trial」の検索結果

Designs adaptive clinical trials including group-sequential (O'Brien-Fleming, Pocock, Lan-DeMets spending), sample-size re-estimation (blinded Friede-Kieser, unblinded Cui-Hung-Wang, Mehta-Pocock promising zone), seamless Phase 2/3 with treatment-arm selection, population enrichment, and response-adaptive randomisation. Covers FDA 2019 Final Adaptive Designs Guidance, FDA 2022 Master Protocols, and ICH E20 Step 2b/3 draft (June 2025, NOT final). Use when planning interim analyses, sample-size re-estimation, or master/platform-trial designs.

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Reads, validates, and prepares CDISC SDTM and ADaM clinical trial data for analysis. Covers SDTM domain joins (DM, AE, EX, VS, LB, DS), ADaM architecture (ADSL, BDS, OCCDS, ADTTE) with traceability, treatment-emergent AE conventions, baseline derivation, SUPPQUAL/NSV handling, Define-XML 2.1, and Pinnacle 21 / CORE validation. Use when working with clinical trial datasets in CDISC SDTM/ADaM format, preparing analysis-ready data, or validating for regulatory submission.

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Performs logistic regression for clinical trial outcomes (binary, ordinal, multinomial) with marginal-vs-conditional estimand reporting per FDA 2023 covariate adjustment guidance, g-computation/standardisation for marginal effects, modified Poisson for RR, Brant test for proportional odds, Firth penalty for separation, and Hauck-Donner detection. Use when modeling binary or ordinal endpoints in confirmatory or exploratory clinical trials.

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Computes sample size and power for clinical trials including continuous, binary, and time-to-event endpoints; superiority, non-inferiority, and equivalence designs; FDA 2016 non-inferiority margin selection with M1/M2 framework; Schoenfeld 1981 and Lakatos 1988 for survival; Schuirmann TOST and 80-125% bioequivalence; minimum clinically important difference (MCID) vs δ distinction. Use when justifying trial size in protocol or SAP per CONSORT 2025 item 16a.

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Performs time-to-event analysis for clinical trials including Cox proportional hazards regression with PH diagnostics, restricted mean survival time (RMST) under non-PH, competing risks via Fine-Gray vs cause-specific Cox, weighted log-rank and MaxCombo for non-proportional hazards, recurrent events (Andersen-Gill, PWP, WLW), and interval-censored data. Use when analyzing time-to-event endpoints (OS, PFS, DOR, TTR, TTNT) in oncology or other clinical trials.

日本語の概要は準備中です。原文の説明を表示しています。

Prepares statistical reports for clinical trials following CONSORT 2025, SPIRIT 2025, ICH E9(R1) estimands, and FDA 2023 covariate adjustment guidance. Covers Table 1 generation, analysis populations (ITT/FAS/PP/Safety), the 5 ICH E9(R1) intercurrent-event strategies, MMRM under MAR (mmrm), reference-based MI (rbmi J2R/CR/CIR), Permutt tipping-point sensitivity, and Rubin's-rules vs frequentist variance debate. Use when preparing regulatory submissions, defining estimands, or implementing missing-data sensitivity analyses.

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Initiates a 6‑month trial of DHEA replacement in women with primary adrenal insufficiency (PAI) who have persistent low libido, depressive symptoms, or low energy despite otherwise optimized glucocorticoid and mineralocorticoid therapy. If the patient does not report a sustained beneficial effect after 6 months, discontinue DHEA.

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Suggests a trial of dehydroepiandrosterone (DHEA) replacement in women with primary adrenal insufficiency (PAI) who report low libido, depressive symptoms, and/or low energy levels despite otherwise optimized glucocorticoid and mineralocorticoid replacement. Consider when a woman with PAI presents with persistent low libido, depressive symptoms, and/or low energy levels after glucocorticoid and mineralocorticoid doses have been titrated to clinical targets.

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既存skillの品質を実走eval駆動で反復改善したいとき、run-skill-live-trialの受け入れFAILやgoal-proxy乖離を改善に引き継ぐときに、PASS詐欺・context汚染・評価縮退を構造的に防ぐeval帰属改善ループとして起動する。

This skill covers detecting anomalies in Modbus/TCP and Modbus RTU communications in industrial control systems. It addresses function code monitoring, register range validation, timing analysis, unauthorized client detection, and deep packet inspection for malformed Modbus frames. The skill leverages Zeek with Modbus protocol analyzers, Suricata IDS with OT rules, and custom Python-based detection using Markov chain models for normal Modbus transaction sequences.

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Prepare a defense-contractor environment for CMMC Level 2 certification: scope CUI and FCI, implement the 110 NIST SP 800-171 Rev 2 security requirements across 14 families, compute the SPRS score with the DoD Assessment Methodology, manage a compliant POA&M, and ready the organization for a C3PAO assessment. Use when an organization handles Controlled Unclassified Information (CUI) under a DoD contract, when a contract carries DFARS clause 252.204-7012/7019/7020/7021, when preparing for or responding to a CMMC assessment, when computing or improving an SPRS score, when building a System Security Plan or POA&M for 800-171, or when scoping which systems are in the CUI boundary. Keywords: CMMC, CMMC Level 2, NIST 800-171, SP 800-171 Rev 2, CUI, FCI, SPRS, DFARS 7012, C3PAO, POA&M, System Security Plan, DoD Assessment Methodology, 110 controls, defense industrial base, DIB, FedRAMP equivalency.

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When the user wants to create or optimize in-app paywalls, upgrade screens, upsell modals, or feature gates. Also use when the user mentions "paywall," "upgrade screen," "upgrade modal," "upsell," "feature gate," "convert free to paid," "freemium conversion," "trial expiration screen," "limit reached screen," "plan upgrade prompt," "in-app pricing," "free users won't upgrade," "trial to paid conversion," or "how do I get users to pay." Use this for any in-product moment where you're asking users to upgrade. Distinct from public pricing pages (see cro) — this focuses on in-product upgrade moments where the user has already experienced value. For pricing decisions, see pricing.

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Product-led growth and customer-base growth for B2B SaaS. Use this skill for self-serve funnel work (activation, time-to-value, free trial vs freemium, PQL definition, in-product upgrade moments, sales-assist triggers) and for growing revenue from existing customers (adoption, expansion, churn-save, renewal marketing, net revenue retention). Also triggers on: PLG, product-led growth, activation, aha moment, time to value, free trial, freemium, PQL, product qualified lead, onboarding, self-serve, customer marketing, expansion revenue, upsell, cross-sell, churn, retention, NRR, renewal.

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Analyze graded `trial_result` JSONL outputs from the eval pipeline, including reliability and custom slicing.

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Expert en biotechnologie (bioinformatics, genomics, CRISPR, clinical trials, FDA)

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When the user wants to optimize their subscription business end-to-end — from trial start through renewal, cancellation, and win-back. Use when the user mentions "subscription lifecycle", "trial conversion", "churn", "cancellation", "win-back", "lapsed subscribers", "dunning", "billing retry", "grace period", "renewal rate", "subscriber LTV", or "resubscribe". For paywall design and pricing strategy, see monetization-strategy. For subscription analytics dashboards, see app-analytics.

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When the user wants to optimize signup, registration, account creation, or trial activation flows. Also use when the user mentions "signup conversions," "registration friction," "signup form optimization," "free trial signup," "reduce signup dropoff," or "account creation flow." For post-signup onboarding, see onboarding-cro. For lead capture forms (not account creation), see form-cro.

日本語の概要は準備中です。原文の説明を表示しています。

This skill covers detecting anomalies in Modbus/TCP and Modbus RTU communications in industrial control systems. It addresses function code monitoring, register range validation, timing analysis, unauthorized client detection, and deep packet inspection for malformed Modbus frames. The skill leverages Zeek with Modbus protocol analyzers, Suricata IDS with OT rules, and custom Python-based detection using Markov chain models for normal Modbus transaction sequences.

日本語の概要は準備中です。原文の説明を表示しています。

Implements multiplicity control for confirmatory clinical trials using graphical procedures (Bretz-Maurer-Hommel), gatekeeping (parallel, serial, mixed), Hochberg/Hommel/Holm with PRDS, and the closed-testing principle (Marcus-Peritz-Gabriel; Goeman 2021 admissibility). Covers FDA Multiple Endpoints Final Guidance (October 2022), graphical procedures via R gMCP, primary + key-secondary + subgroup hierarchies, and FWER vs FDR distinction. Use when designing the multiplicity strategy for confirmatory trials with multiple primary or key secondary endpoints.

日本語の概要は準備中です。原文の説明を表示しています。

Computes sample size and power for clinical trials including continuous, binary, and time-to-event endpoints; superiority, non-inferiority, and equivalence designs; FDA 2016 non-inferiority margin selection with M1/M2 framework; Schoenfeld 1981 and Lakatos 1988 for survival; Schuirmann TOST and 80-125% bioequivalence; minimum clinically important difference (MCID) vs δ distinction. Use when justifying trial size in protocol or SAP per CONSORT 2025 item 7.

日本語の概要は準備中です。原文の説明を表示しています。

Performs time-to-event analysis for clinical trials including Cox proportional hazards regression with PH diagnostics, restricted mean survival time (RMST) under non-PH, competing risks via Fine-Gray vs cause-specific Cox, weighted log-rank and MaxCombo for non-proportional hazards, recurrent events (Andersen-Gill, PWP, WLW), and interval-censored data. Use when analyzing time-to-event endpoints (OS, PFS, DOR, TTR, TTNT) in oncology or other clinical trials.

日本語の概要は準備中です。原文の説明を表示しています。

Prepares statistical reports for clinical trials following CONSORT 2025, SPIRIT 2025, ICH E9(R1) estimands, and FDA 2023 covariate adjustment guidance. Covers Table 1 generation, analysis populations (ITT/FAS/PP/Safety), the 5 ICH E9(R1) intercurrent-event strategies, MMRM under MAR (mmrm), reference-based MI (rbmi J2R/CR/CIR), Permutt tipping-point sensitivity, and Rubin's-rules vs frequentist variance debate. Use when preparing regulatory submissions, defining estimands, or implementing missing-data sensitivity analyses.

日本語の概要は準備中です。原文の説明を表示しています。

Designs adaptive clinical trials including group-sequential (O'Brien-Fleming, Pocock, Lan-DeMets spending), sample-size re-estimation (blinded Friede-Kieser, unblinded Cui-Hung-Wang, Mehta-Pocock promising zone), seamless Phase 2/3 with treatment-arm selection, population enrichment, and response-adaptive randomisation. Covers FDA 2019 Final Adaptive Designs Guidance, FDA 2022 Master Protocols, and ICH E20 Step 2b/3 draft (June 2025, NOT final). Use when planning interim analyses, sample-size re-estimation, or master/platform-trial designs.

日本語の概要は準備中です。原文の説明を表示しています。

Reads, validates, and prepares CDISC SDTM and ADaM clinical trial data for analysis. Covers SDTM domain joins (DM, AE, EX, VS, LB, DS), ADaM architecture (ADSL, BDS, OCCDS, ADTTE) with traceability, treatment-emergent AE conventions, baseline derivation, SUPPQUAL/NSV handling, Define-XML 2.1, and Pinnacle 21 / CORE validation. Use when working with clinical trial datasets in CDISC SDTM/ADaM format, preparing analysis-ready data, or validating for regulatory submission.

日本語の概要は準備中です。原文の説明を表示しています。