`clinical-trial-design`POST

Generate a precedent-backed clinical trial design strategy.

Analyzes trial precedents, regulatory patterns, endpoint/comparator expectations, safety monitoring needs, operational feasibility, and competitive benchmarks to recommend a structured clinical trial design strategy. Recommendations are strategic and do not replace biostatistics, clinical operations, or regulatory review.

Endpoint

POST https://api.frontwind.ai/v1/agents/clinical-trial-design

Example

curl -X POST https://api.frontwind.ai/v1/agents/clinical-trial-design \
  -H "Authorization: Bearer fw_live_..." \
  -H "Content-Type: application/json" \
  -d '{ "asset_name": "FW-201", "indication": "relapsed/refractory multiple myeloma", "modality": "bispecific antibody", "mechanism_of_action": "BCMA x CD3 T-cell engagement", "target": "BCMA", "development_stage": "Phase 2", "geography": "FDA", "line_of_therapy": "after at least three prior lines", "preferred_endpoint": "ORR with DoR", "competitor_trials": [ "MajesTEC-1", "MagnetisMM-3", "KarMMa" ] }'

Request body

Field	Type	Required	Description
`asset_name`	`string`	Yes
`indication`	`string`	Yes
`modality`	`string`	Yes
`mechanism_of_action`	`string`	Yes
`target`	`string`	Yes
`development_stage`	`string`	Yes
`geography`	`string`	Yes	Regulatory geography, e.g. FDA, EMA, PMDA.
`intended_label_claim`	`string`	No
`line_of_therapy`	`string`	No
`biomarker_strategy`	`string`	No
`target_patient_population`	`string`	No
`safety_profile`	`object`	No
`preliminary_efficacy_data`	`object`	No
`competitor_trials`	`array`	No
`preferred_endpoint`	`string`	No
`combination_partners`	`array`	No
`route_of_administration`	`string`	No
`dosing_schedule`	`string`	No
`regulatory_designations`	`array`	No
`manufacturing_constraints`	`object`	No
`use_cache`	`boolean`	default false

Response data

Field	Type	Description
`executive_summary`	`object`
`recommended_trial_design`	`object`
`proposed_trial_schema`	`object`
`target_patient_population`	`object`
`endpoint_strategy`	`array`
`comparator_strategy`	`object`
`statistical_design_recommendations`	`object`
`safety_monitoring_recommendations`	`object`
`operational_feasibility_analysis`	`object`
`competitive_trial_benchmarking`	`array`
`regulatory_risks`	`array`
`strategy_scenarios`	`array`
`recommended_next_steps`	`array`
`precedents`	`array`
`sources`	`array`
`assumptions`	`array`
`warnings`	`array`

Example response

{
  "ok": true,
  "agent": "clinical-trial-design",
  "data": {
    "executive_summary": {
      "recommended_trial_strategy": "Base case is a single-arm Phase 2 in heavily pretreated RRMM with ORR and DoR as the evidence package, paired with an early randomized confirmatory plan [1][2].",
      "likely_regulatory_pathway": "Accelerated approval may be plausible if response durability and safety are compelling in a refractory population [1][2].",
      "major_design_risks": [
        "single-arm evidence dependency [1]",
        "CRS/infection monitoring burden [2]"
      ],
      "confidence": "Medium",
      "confidence_score": 65,
      "source_ids": [
        "1",
        "2"
      ]
    },
    "recommended_trial_design": {
      "design_type": "Phase 2 single-arm with confirmatory randomized follow-on",
      "rationale": "A refractory setting can support response-based development when randomized SOC is operationally difficult, but confirmatory evidence remains a key risk [1].",
      "source_ids": [
        "1"
      ]
    },
    "competitive_trial_benchmarking": [
      {
        "asset": "teclistamab",
        "phase": "Phase 1/2",
        "population": "RRMM after multiple prior lines",
        "endpoint": "ORR",
        "comparator": "single-arm",
        "sample_size": "N/R",
        "outcome": "Supported approval precedent [1]",
        "source_ids": [
          "1"
        ]
      }
    ],
    "warnings": [
      "Design recommendations are strategic and not a final SAP or regulatory advice."
    ]
  },
  "elapsed_s": 42
}