clinical-research-tools

name: clinical-research-tools description: Clinical research workflow guide for protocol design, endpoint selection, evidence grading, reporting-guideline selection, statistical planning, and clinical-trial evidence synthesis. Use when the user asks to design or review human-subjects research, trial analyses, observational studies, study protocols, CSRs, or clinical evidence summaries without requesting patient-specific diagnosis or treatment decisions.

Clinical Research Tools

Use this skill for group-level human research work, not bedside care.

Typical triggers:

• choose between RCT, cohort, case-control, cross-sectional, diagnostic, or single-arm designs
• define primary and secondary endpoints, estimands, eligibility criteria, or subgroup analyses
• select the right reporting guideline such as CONSORT, STROBE, PRISMA, STARD, TRIPOD, SPIRIT, or CARE
• draft protocol, SAP, CSR, or evidence-summary outlines
• review bias, confounding, missing data, and sample-size assumptions
• prepare trial or real-world-evidence summaries for drug-discovery programs

Working Rules

1. Keep the task at the study or cohort level.
2. Separate confirmed study facts from proposed design choices.
3. State assumptions behind endpoint, power, and statistical-model choices.
4. Call out data leakage, immortal-time bias, selection bias, and confounding whenever relevant.
5. Do not present DrugClaw as giving medical advice, treatment recommendations, or diagnostic decisions.

Study Design Map

Use this quick routing:

• RCT: intervention efficacy, causal inference, registration-ready protocols
• Prospective cohort: prognosis, exposure-outcome tracking, real-world evidence
• Retrospective cohort: registry or EHR analyses with explicit confounding control
• Case-control: rare outcomes or exploratory risk-factor work
• Cross-sectional: prevalence, survey snapshots, baseline association work
• Diagnostic accuracy: sensitivity, specificity, ROC, calibration, decision curves
• Prediction model: risk scores, survival models, treatment-response models with external validation plans

Reporting Guideline Map

Choose and state the governing framework early:

• CONSORT: randomized trials
• SPIRIT: trial protocols
• STROBE: observational studies
• PRISMA: systematic reviews and meta-analysis
• STARD: diagnostic accuracy studies
• TRIPOD: prediction models
• CARE: case reports
• ICH E3: clinical study reports

Protocol Workflow

For protocol or study-design requests:

1. Define population, intervention or exposure, comparator, outcome, and timeframe.
2. State inclusion and exclusion criteria.
3. Define primary endpoint, key secondary endpoints, and censoring rules.
4. Choose analysis populations: ITT, mITT, per-protocol, safety.
5. Describe missing-data handling and sensitivity analyses.
6. State sample-size assumptions clearly: alpha, power, effect size, event rate, dropout.
7. Specify monitoring, ethics, registration, and data-governance requirements.

Statistical Planning Checklist

Always address:

• endpoint type: binary, continuous, count, time-to-event
• stratification variables and subgroup policy
• multiplicity control
• covariate adjustment policy
• temporal leakage and look-ahead bias
• external validation or temporal validation when building prediction models
• calibration, not only discrimination, for predictive work

Evidence Synthesis

For evidence summaries:

• identify study type and evidence level
• note patient population, line of therapy, biomarker context, and comparator
• distinguish efficacy, safety, and external-validity conclusions
• state what remains uncertain
• use cautious language for indirect or observational evidence

Outputs

Good outputs usually include:

• one-page design summary or protocol skeleton
• endpoint table
• statistical analysis outline
• bias and limitation section
• reporting-guideline checklist

Related Skills

For ClinicalTrials.gov, openFDA, or OpenAlex lookups, activate pharma-db-tools. For cohort tables, biosignals, or DICOM datasets, activate medical-data-tools. For citation cleanup, evidence matrices, or structured review drafting, activate literature-review-tools. For hypothesis tests, regression, or effect-size reporting, activate stat-modeling-tools. For Kaplan-Meier, log-rank, or Cox workflows, activate survival-analysis-tools. For manuscript critique, hypothesis framing, or reproducibility checklists, activate scientific-workflow-tools. For molecular, variant, pathway, or structure work, activate bio-tools, bio-db-tools, chem-tools, or docking-tools as appropriate.