> For the complete documentation index, see [llms.txt](https://docs.owkin.com/llms.txt). Markdown versions of documentation pages are available by appending `.md` to page URLs; this page is available as [Markdown](https://docs.owkin.com/what-you-can-do-with-k-pro/trial-navigator-1/navigate-clinical-trials.md). # Navigate clinical trials ## Overview Trial Navigator is a specialized tool within Owkin K designed to help pharmaceutical professionals analyze the clinical trial landscape. It transforms natural language questions into powerful visualizations and structured insights, enabling you to: * **Map competitive landscapes** across therapeutic areas * **Track competitor pipelines** and development timelines * **Analyze trial design assumptions** for individual studies Trial Navigator automatically interprets your questions and delivers the appropriate analysis, whether you need a broad market overview or a deep-dive into a specific trial’s statistical assumptions. **Tips for effective queries:** * Be specific about the therapeutic area, indication, or mechanism of action * Mention specific sponsors, drugs, or NCT IDs when relevant * Specify trial phases if you want to focus on a particular development stage * Include timeframes (e.g., “trials that started after 2020”) to narrow results *** ## Key capabilities ### Competitive landscape analysis Get a visual timeline of clinical trials across any therapeutic area, mechanism of action, or competitive set. **What you get:** * **Interactive gantt chart** showing trial phases and timelines * **Detailed results table** with all matching trial metadata * **Summary statistics** (enrollment totals, sponsor counts, phase distribution) * **Direct links** to [ClinicalTrials.gov](http://clinicaltrials.gov) for each trial **Example queries:** ``` "What are the trials targeting ERBB2 for breast cancer?" "Show me Phase III immunotherapy trials in NSCLC" "List clinical trials for Alzheimer's disease involving gene therapy" "What trials is Pfizer running in melanoma?" "Show me all ADC trials that started after 2022" ``` ### Single trial statistical analysis Deep-dive into the statistical assumptions underlying any specific trial’s design and projected readout times. **What you get:** * **Statistical projection plot** showing enrollment and survival curves * **Predicted median OS and PFS** based on historical data * **Predicted enrollment duration** estimates * **Reference trials** used to generate predictions **Example queries:** ``` "Perform a statistical analysis for trial NCT04589845" "What are the underlying assumptions for readout times of trial NCT04589845?" "Show me the statistical projection plot for the NCT04589845 trial" ``` #### See it in action {% embed url="" %} ## Output formats ### Gantt chart view The timeline visualization displays: * **X-axis:** Time (years) * **Y-axis:** Individual trials (grouped by phase, sorted by start date) * **Bars:** Represent trial duration with phase progression markers
### Table view A sortable, filterable table containing: * NCT ID (with link to [ClinicalTrials.gov](http://clinicaltrials.gov)) * Sponsor information * Phase, indication and drug information * Key results
### Summary statistics Automatically computed metrics and answer summary that can include for example: * Total trial count matching your query * Phase distribution breakdown * Top indications represented
### Statistical projection Interactive plotly visualization including: * Data points: Enrollment curve, survival projections * Reference trials: NCT ID used for predictions
*** ## Searchable data fields Trial Navigator provides access to a comprehensive clinical trials dataset. You can filter and search across the following dimensions: ### Identification | Field | Description | | --------------- | ---------------------------------------------------------- | | NCT ID | [ClinicalTrials.gov](http://clinicaltrials.gov) identifier | | Brief Title | Short trial title | | Official Title | Full formal trial title | | Commercial Name | Sponsor’s commercial trial name | ### Status & Timeline | Field | Description | | ----------------------- | -------------------------------------------------------------- | | Overall Status | Recruiting, Active Not Recruiting, Completed, Terminated, etc. | | Trial Start Date | Date the trial began | | Primary Completion Date | Date of primary outcome measurement | | Completion Date | Full study completion date | | Trial Duration | Duration in days | ### Design | Field | Description | | -------------- | --------------------------------------------------------- | | Study Type | Interventional, Observational | | Trial Phase | I, II, III, IV, I/II, II/III, III/IV | | Randomization | Whether the trial is randomized | | Number of Arms | Count of treatment arms | | Group Types | Experimental, Active Comparator, Placebo Comparator, etc. | ### Sponsors | Field | Description | | ------------------------- | ----------------------------------------------------------------------- | | Private/Industry Sponsors | Pharmaceutical and biotech companies (Pfizer, Roche, AstraZeneca, etc.) | | Public/Academic Sponsors | Universities, hospitals, research centers, government agencies | | Industry Sponsored | Boolean flag for industry involvement | ### Enrollment & accrual | Field | Description | | ------------------- | ---------------------------------- | | Enrollment | Number of participants | | Accrual Target | Target number of subjects | | Accrual Actual | Actual enrolled subjects | | Enrollment Duration | Time to complete enrollment (days) | ### Geography | Field | Description | | --------------- | --------------------------------------------------- | | Trial Countries | Countries where the trial is conducted | | Trial Regions | Regions (North America, Western Europe, Asia, etc.) | | Number of Sites | Count of trial sites | ### Eligibility criteria | Field | Description | | ---------------- | --------------------------------------------------------------------------- | | Gender | Both, Female Only, Male Only | | Age Range | Minimum and maximum age for eligibility | | ECOG Status | Performance status requirements (0-4 scale) | | Disease Stages | Localized, locally advanced, advanced, metastatic, resectable, unresectable | | Disease Paths | Persistent, recurrent, refractory, relapsed, resistant | | Lines of Therapy | Prior treatment requirements | ### Indications (cancer types) Trial Navigator covers a comprehensive oncology landscape including: **Solid Tumors:** * Breast, Lung (NSCLC, SCLC), Colorectal, Pancreas * Melanoma, Renal, Bladder, Prostate * Head/Neck, Esophageal, Gastric, Liver * Ovarian, Endometrial, Cervical * CNS tumors (Glioblastoma, Astrocytoma, Meningioma, etc.) * And many more… **Hematological Malignancies:** * Leukemia (ALL, AML, CML, CLL) * Lymphoma (Hodgkin’s, Non-Hodgkin’s) * Multiple Myeloma * Myelodysplastic Syndrome * Myeloproliferative Neoplasms ### Treatment & intervention | Field | Description | | -------------------- | ------------------------------------------------------------------------------ | | Drug Names | Investigational drug names | | Drug Type | ADC, Antibody Bispecific, Antibody Multispecific, Gene Therapy, Small Molecule | | Mechanisms of Action | JAK inhibitor, CDK inhibitor, PD-1/PD-L1 inhibitor, etc. | | Targets (HGNC) | Gene symbols (KRAS, TP53, BRCA1, EGFR, ERBB2, etc.) | | Biomarkers | Biomarkers used in trial selection | | Combination Therapy | Whether the trial tests a drug combination | ### Endpoints | Field | Description | | ----------------- | -------------------------------------------------- | | Primary Endpoints | OS, PFS, DUAL, or other | | Has OS | Overall Survival as endpoint | | Has PFS | Progression-Free Survival as endpoint | | Has EFS/DFS/RFS | Event-free, Disease-free, Recurrence-free Survival | ### Outcomes (actual & predicted) | Field | Description | | ----------------------------- | ---------------------------------------- | | Objective Response Rate | ORR from trial results | | Disease Control Rate | DCR from trial results | | Median OS (months) | Actual median overall survival | | Median PFS (months) | Actual median progression-free survival | | Predicted Median OS | AI-predicted median OS | | Predicted Median PFS | AI-predicted median PFS | | Predicted Enrollment Duration | AI-predicted time to complete enrollment | *** ## Query examples by use case ### Competitive Intelligence **Map the competitive landscape for a target:** ``` "Show me all trials targeting HER2 in breast cancer" "What trials are investigating KRAS G12C inhibitors?" "List all PD-1/PD-L1 trials in NSCLC since 2020" ``` **Track competitor pipelines:** ``` "What Phase III trials is Merck running in oncology?" "Show me Roche's ADC pipeline across all indications" "List all trials sponsored by BioNTech in solid tumors" ``` **Analyze mechanism trends:** ``` "Show me all bispecific antibody trials in hematological malignancies" "What gene therapy trials are active in oncology?" "List all CAR-T trials recruiting in the US" ``` ### Portfolio management **Assess development timelines:** ``` "Statistical analysis for NCT04589845" "What are the projected readout dates for trial NCT04589845?" ``` **Compare trial designs:** ``` "Show me Phase III trials in 1L metastatic NSCLC with OS as primary endpoint" "What trials are testing combinations with pembrolizumab in melanoma?" ``` **Identify white space opportunities:** ``` "What Phase II trials are there in cholangiocarcinoma?" "Show me trials in myelodysplastic syndrome that started after 2021" ``` ### Clinical development strategy **Benchmark enrollment assumptions:** ``` "What is the typical enrollment for Phase III NSCLC trials?" "Show me completed trials in breast cancer with enrollment over 500 patients" ``` **Analyze endpoint selection:** ``` "What trials use dual OS/PFS endpoints in gastric cancer?" "Show me Phase III trials with PFS as primary endpoint in ovarian cancer" ``` **Understand eligibility trends:** ``` "What trials require ECOG 0-1 in metastatic colorectal cancer?" "Show me trials enrolling patients with prior immunotherapy in melanoma" ``` *** ## Advanced Features #### Comparative Queries Trial Navigator can handle queries that compare against specific trial values: ``` "Show me trials that started after trial NCT04589845" "Find trials with higher enrollment than NCT04589845" "What trials have longer duration than the NCT04589845 study?" ``` The system automatically looks up the reference trial’s values and uses them to filter results. #### Multi-Step Analysis For complex queries requiring multiple data lookups, Trial Navigator orchestrates the analysis automatically: ``` "For the top 3 trials by enrollment in lung cancer, show their statistical projections" ``` The system will: 1. Find the top 3 trials by enrollment 2. Extract their NCT IDs 3. Generate statistical projections for each #### Smart Name Resolution Trial Navigator understands synonyms and variations: * “Keytruda” maps to pembrolizumab * “Herceptin” maps to trastuzumab * Various gene name formats (ERBB2/HER2/neu) * Sponsor name variations (Merck & Co., MSD, Merck Sharp & Dohme) *** ### Limitations * **Data scope:** Primarily oncology-focused; coverage in other therapeutic areas may vary * **Statistical projections:** Available only for Phase II and III trials with sufficient historical data * **Data freshness:** Dataset is updated periodically; for real-time status, verify on [ClinicalTrials.gov](http://clinicaltrials.gov) --- # Agent Instructions This documentation is published with GitBook. GitBook is the documentation platform designed so that both humans and AI agents can read, navigate, and reason over technical content effectively. Learn more at gitbook.com. ## Querying This Documentation If you need additional information that is not directly available in this page, you can query the documentation dynamically by asking a question. Perform an HTTP GET request on the current page URL with the `ask` query parameter, and the optional `goal` query parameter: ``` GET https://docs.owkin.com/what-you-can-do-with-k-pro/trial-navigator-1/navigate-clinical-trials.md?ask=&goal= ``` `ask` is the immediate question: it should be specific, self-contained, and written in natural language. `goal` is optional and describes the broader end goal you are ultimately trying to accomplish on behalf of the user. GitBook uses it to tailor the answer towards what is most useful for that goal. The response will contain a direct answer to the question and relevant excerpts and sources from the documentation. Use this mechanism when the answer is not explicitly present in the current page, you need clarification or additional context, or you want to retrieve related documentation sections.