「trial」の検索結果

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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Validates predictive models on omics and biomedical data with nested cross-validation, group/batch/temporal-aware splits, the full data-leakage taxonomy, probability calibration, decision-curve net benefit, optimism correction, sample-size planning, and TRIPOD+AI reporting. Use when estimating model performance honestly, choosing a CV scheme, detecting leakage, or judging whether reported discrimination means the model is actually useful. For feature selection itself see machine-learning/biomarker-discovery; for confirmatory-trial inference see clinical-biostatistics/trial-reporting.

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Literature: retrieve document-level scientific evidence from publications, clinical-trial registries, and patent sources. Use for PubMed records, reproducible searches, trial registrations, patent evidence, abstracts, study metadata, stable identifiers, and citation provenance.

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Draft or review an employer's Otameshi Tenshoku listing so a candidate can decide whether to apply: check item by item that the work, deliverable, out-of-scope tasks, required experience, support, hours, schedule, location, compensation, contract form and payment timing are stated, find open-ended, unpaid-company-work, guarantee, personal-attribute and unverifiable wording, and confirm that the hours, weekly availability, period, rate and budget hold together. Use when a hiring manager, recruiter or small-business owner wants a listing written from a plan, wants an existing draft or published listing reviewed before or after posting, or wants to know why applications are not coming; do not use to design the work itself (trial-work-design), to reply to applicants (applicant-reply), to state market rates, legal, tax or service conditions from memory, or to post or update the listing on the user's behalf.

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Reply to an applicant for an employer's Otameshi Tenshoku listing: match the application against the listed requirements item by item on what the applicant actually stated, list the questions still open, and draft an invitation, a request for clarification, a hold notice or a decline that sticks to the listed conditions, keeps other applicants and internal notes out, and presents any new work or dates as a proposal rather than an agreed term. Use when a hiring manager, recruiter or small-business owner has applications to answer, wants to know what to ask before inviting, or has to decline; do not use to judge an applicant's aptitude or predict hiring outcomes, to screen on personal attributes unrelated to the work, to design the work (trial-work-design) or the listing (trial-listing-draft), or to send the message or update applicant records on the user's behalf.

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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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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.

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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.

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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.

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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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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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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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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 page-cro) — this focuses on in-product upgrade moments where the user has already experienced value. For pricing decisions, see pricing-strategy.

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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。

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。

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.

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。

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。

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。

Early-user discovery and feedback trials. Use when reviewing unfamiliar AI Matrx accounts, classifying owner relationships, recommending trial plans, or running approved outreach and reply checks.

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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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Bluetooth Classic (BR/EDR) attack methodology — device discovery, service enumeration via SDP, LMP/L2CAP layer attacks, legacy PIN cracking (BlueBorne / KNOB), Bluetooth file-transfer abuse (BlueSnarfing legacy), unauthenticated profile abuse (HSP, HFP, OPP), and modern relevance against older industrial / automotive / accessory targets. Use when in-scope devices use Bluetooth Classic (Bluetooth ≤ 4.0 BR/EDR) — common in legacy car kits, industrial sensors, older medical devices, and audio accessories.

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実際の開発課題で複数のコーディングエージェントを比較するスキル。成功率、取得可能なAPI費用、所要時間、繰り返し実行の安定性を測り、選定や更新後の評価に使えます。

• 実際の開発課題でエージェントを比較
• 新しいツールやモデルの導入前評価
• エージェント更新後の性能確認