Clinical trial results Summarization Prompt

# Clinical Trial Results Summarization Prompt ## Background & Context Clinical trial results reports are official documents that detail the outcomes, methodology, and findings of clinical studies testing medical interventions (drugs, devices, procedures, etc.) on human participants. These reports are typically created by pharmaceutical companies, academic research institutions, or contract research organizations (CROs). They are consumed by regulatory authorities (FDA, EMA, etc.), healthcare professionals, investors, patient advocacy groups, and other researchers. These reports serve as the scientific foundation for regulatory approval decisions, clinical practice guidelines, and future research directions. ## Report Structure & Components Clinical trial results reports typically include: 1. Study overview and trial identification (NCT number, protocol ID) 2. Study design (randomized, blinded, controlled, etc.) 3. Participant demographics and baseline characteristics 4. Inclusion/exclusion criteria 5. Intervention details (dosing, administration, duration) 6. Primary and secondary endpoints/outcome measures 7. Statistical analysis methodology 8. Efficacy results (primary and secondary endpoints) 9. Safety and adverse event data 10. Statistical significance calculations (p-values, confidence intervals) 11. Subgroup analyses 12. Discussion of results and limitations 13. Conclusions and implications ## Critical Information to Extract Focus on extracting: 1. Trial identification (name, phase, NCT number) 2. Study population size and key demographics 3. Study design (randomized, controlled, blinded, etc.) 4. Treatment arms and interventions tested 5. Primary endpoint results with statistical significance 6. Key secondary endpoint results 7. Safety profile and significant adverse events 8. Statistical methods used and their appropriateness 9. Any notable subgroup analyses or exploratory findings 10. Study limitations and potential biases 11. Authors' conclusions and recommendations 12. Funding sources and potential conflicts of interest ## Stakeholder Priorities Different stakeholders need different aspects emphasized: **Regulatory authorities:** - Methodological rigor - Complete safety profile - Statistical validity - Protocol adherence **Healthcare professionals:** - Clinical significance vs. statistical significance - Number needed to treat/harm - Applicability to real-world patients - Comparison to standard of care **Investors/executives:** - Market potential implications - Competitive positioning - Timeline to potential approval - Risk/benefit profile **Researchers:** - Methodological details - Statistical approach - Gaps requiring further study - Comparison to related trials ## Output Format Guidelines Structure the summary as follows: 1. **Executive Summary** (2-3 sentences highlighting key findings) 2. **Trial Overview** (study design, population, interventions - 1 paragraph) 3. **Key Results** (bullet points for primary and important secondary endpoints) 4. **Safety Profile** (concise summary of notable adverse events and safety signals) 5. **Limitations** (bullet points of key limitations affecting interpretation) 6. **Implications** (1-2 paragraphs on significance for clinical practice, regulatory pathway, or future research) Use precise medical terminology but explain specialized concepts. Include actual numerical data (percentages, p-values, confidence intervals) for key outcomes. ## Special Considerations - Distinguish between statistical significance and clinical relevance - Note the phase of the trial as context for interpreting results (Phase I-IV) - Highlight any discrepancies between pre-specified and reported outcomes - Be precise about the nature of endpoints (surrogate markers vs. clinical outcomes) - Consider the generalizability of results to broader populations - Interpret p-values and statistical tests appropriately - Identify potential biases in study design or reporting - Note whether the trial was completed as planned or terminated early - Be attentive to industry-funded studies and potential reporting biases ## Sample Output Structure **EXECUTIVE SUMMARY** Study XYZ, a Phase III randomized controlled trial, demonstrated that Drug A reduced mortality by 25% compared to standard of care in advanced non-small cell lung cancer patients with statistical significance (p=0.003). **TRIAL OVERVIEW** - Trial ID: NCT01234567, CLARION Study - Design: Multicenter, double-blind, randomized, placebo-controlled Phase III trial - Population: 782 adults with stage IIIB/IV non-small cell lung cancer, ECOG 0-1 - Intervention: Drug A (500mg daily) vs. placebo, both with standard chemotherapy - Primary endpoint: Overall survival at 12 months **KEY RESULTS** - Primary endpoint: 12-month overall survival was 65% with Drug A vs. 52% with placebo (HR 0.75, 95% CI 0.62-0.90, p=0.003) - Secondary endpoints: * Progression-free survival: 8.3 vs. 5.1 months (HR 0.68, p<0.001) * Objective response rate: 42% vs. 29% (p=0.01) * Quality of life: Significant improvement in FACT-L scores (p=0.02) **SAFETY PROFILE** - Most common adverse events: Fatigue (45% vs. 30%), nausea (38% vs. 35%) - Serious adverse events: 18% in Drug A arm vs. 12% in placebo arm - Treatment discontinuation due to adverse events: 7% vs. 4% - Treatment-related deaths: 2 (<1%) vs. 1 (<1%) **LIMITATIONS** - Underrepresentation of elderly patients and those with ECOG ≥2 - Median follow-up of only 14 months may limit long-term safety assessment - Single biomarker (PD-L1) used for stratification - 15% crossover rate may have diluted survival difference **IMPLICATIONS** Drug A demonstrates clinically meaningful improvement in overall survival with a manageable safety profile for advanced NSCLC patients. These results suggest Drug A could become a new standard-of-care first-line therapy for this population. The benefit appears most pronounced in patients with high PD-L1 expression, indicating potential for biomarker-guided treatment selection. Regulatory submission is planned for Q3 2023, with potential approval expected mid-2024.