clinical global trials derived

{
  "input": {
    "type": "http",
    "method": "GET",
    "queryParams": {
      "lang": "en | es | fr | de | ja | zh | ko | pt | ar | hi (default: en)",
      "region": "global | africa | asia | europe | latin-america | middle-east | north-america (default: global)",
      "condition": "Disease — e.g. \"Malaria\" | \"Tuberculosis\" | \"Dengue\" | \"Sickle Cell Disease\" | \"Chagas Disease\""
    }
  },
  "output": {
    "type": "json",
    "example": {
      "query_summary": {
        "region": "global",
        "condition": "Malaria"
      },
      "phase3_highlights": [
        {
          "drug": "R21/Matrix-M",
          "notes": "WHO prequalification received 2023. First malaria vaccine with >75% efficacy in high-transmission settings.",
          "sponsor": "Serum Institute / Oxford",
          "countries": [
            "Burkina Faso",
            "Kenya",
            "Mali",
            "Tanzania"
          ]
        }
      ],
      "regulatory_landscape": {
        "ema": "Article 58 mechanism for non-EU disease burden assessments. R21 assessed via UK MHRA.",
        "fda": "Limited footprint — malaria not a US priority market; few NDA filings",
        "nmpa_china": "Artemisinin derivatives approved; combination therapies standardized under WHO guidelines",
        "who_prequalification": "Primary pathway for SSA deployment. RTS,S and R21 both WHO-prequalified."
      },
      "unmet_needs_by_region": {
        "latin_america": "Vivax malaria (neglected vs. falciparum)",
        "southeast_asia": "Artemisinin resistance (Pfkrelch mutations) — urgent — treatment of resistant falciparum",
        "sub_saharan_africa": "Pediatric dosing, pregnancy, severe malaria, transmission blocking"
      },
      "opportunity_assessment": "R21 scale-up is the near-term priority. Resistance crisis in SE Asia creates urgent Phase 3 need for alternative regimens.",
      "global_trial_distribution": {
        "most_active_countries": [
          "Kenya (45 trials)",
          "Uganda (38)",
          "Burkina Faso (31)",
          "Mali (28)",
          "Tanzania (24)",
          "United States (22)",
          "Thailand (19)"
        ],
        "clinicaltrials_gov_count": 312,
        "geographic_concentration": "Sub-Saharan Africa dominates — 68% of all active malaria trials",
        "estimated_non_us_registries": "200+ additional trials in WHO ICTRP member registries"
      },
      "global_registries_coverage": {
        "ctri_india": "18 trials — India significant manufacturer (Serum Institute)",
        "chictr_china": "Limited malaria — primarily domestic infectious disease",
        "anzctr_australia": "5 trials — malaria research centers in Melbourne (Burnet Institute)",
        "clinical_trials_eu": "12 EU-registered trials"
      },
      "development_finance_context": "GAVI, Global Fund, UNITAID, PMI, USAID funding dominant. Wellcome Trust largest private funder."
    }
  }
}