{
  "question_id": "W242",
  "slug": "drug-approved-on-simulated-evidence",
  "title": "A drug is approved on AI-simulated evidence, without an efficacy trial",
  "type": "binary",
  "resolution": {
    "levels": [],
    "values": [],
    "annotations": []
  },
  "forecasts": [
    {
      "question_id": "W242",
      "forecast_date": "2026-09-20",
      "evidence_cutoff": "2026-09-20",
      "method": "wide-v2",
      "opened": "2026-09-16",
      "linked_questions": [],
      "reading_adopted": "I treat an EU authorization as eligible even if the product separately has a US Animal Rule approval, but animal-to-human pharmacokinetic dose bridging alone does not constitute substitution by simulated human efficacy.",
      "summary": null,
      "ambiguities": [],
      "key_drivers": [],
      "would_update_on": [],
      "forecasts": [
        {
          "period_end": "2026-09-30",
          "p_yes": 0.0002
        },
        {
          "period_end": "2026-12-31",
          "p_yes": 0.0007
        },
        {
          "period_end": "2027-03-31",
          "p_yes": 0.001399
        },
        {
          "period_end": "2027-06-30",
          "p_yes": 0.002298
        },
        {
          "period_end": "2027-09-30",
          "p_yes": 0.003396
        },
        {
          "period_end": "2027-12-31",
          "p_yes": 0.004691
        },
        {
          "period_end": "2028-03-31",
          "p_yes": 0.006184
        },
        {
          "period_end": "2028-06-30",
          "p_yes": 0.007973
        },
        {
          "period_end": "2028-09-30",
          "p_yes": 0.010056
        },
        {
          "period_end": "2028-12-31",
          "p_yes": 0.012531
        },
        {
          "period_end": "2029-03-31",
          "p_yes": 0.015494
        },
        {
          "period_end": "2029-06-30",
          "p_yes": 0.018939
        },
        {
          "period_end": "2029-09-30",
          "p_yes": 0.022864
        },
        {
          "period_end": "2029-12-31",
          "p_yes": 0.027261
        },
        {
          "period_end": "2030-03-31",
          "p_yes": 0.032124
        },
        {
          "period_end": "2030-06-30",
          "p_yes": 0.037448
        },
        {
          "period_end": "2030-09-30",
          "p_yes": 0.043223
        },
        {
          "period_end": "2030-12-31",
          "p_yes": 0.049442
        },
        {
          "period_end": "2031-03-31",
          "p_yes": 0.056096
        },
        {
          "period_end": "2031-06-30",
          "p_yes": 0.063175
        },
        {
          "period_end": "2031-09-30",
          "p_yes": 0.07067
        }
      ],
      "passes": []
    },
    {
      "question_id": "W242",
      "forecast_date": "2026-09-27",
      "evidence_cutoff": "2026-09-27",
      "method": "wide-v2",
      "opened": "2026-09-16",
      "linked_questions": [],
      "reading_adopted": "I require explicit acceptance of model-generated human efficacy predictions rather than PK or bioequivalence bridging alone, and apply the absence-of-efficacy-trials requirement across all indications and populations worldwide.",
      "summary": null,
      "ambiguities": [],
      "key_drivers": [],
      "would_update_on": [],
      "forecasts": [
        {
          "period_end": "2026-09-30",
          "p_yes": 0.0001
        },
        {
          "period_end": "2026-12-31",
          "p_yes": 0.0006
        },
        {
          "period_end": "2027-03-31",
          "p_yes": 0.001399
        },
        {
          "period_end": "2027-06-30",
          "p_yes": 0.002398
        },
        {
          "period_end": "2027-09-30",
          "p_yes": 0.003595
        },
        {
          "period_end": "2027-12-31",
          "p_yes": 0.00509
        },
        {
          "period_end": "2028-03-31",
          "p_yes": 0.00708
        },
        {
          "period_end": "2028-06-30",
          "p_yes": 0.009562
        },
        {
          "period_end": "2028-09-30",
          "p_yes": 0.012533
        },
        {
          "period_end": "2028-12-31",
          "p_yes": 0.015989
        },
        {
          "period_end": "2029-03-31",
          "p_yes": 0.019925
        },
        {
          "period_end": "2029-06-30",
          "p_yes": 0.024336
        },
        {
          "period_end": "2029-09-30",
          "p_yes": 0.029214
        },
        {
          "period_end": "2029-12-31",
          "p_yes": 0.034553
        },
        {
          "period_end": "2030-03-31",
          "p_yes": 0.040346
        },
        {
          "period_end": "2030-06-30",
          "p_yes": 0.046584
        },
        {
          "period_end": "2030-09-30",
          "p_yes": 0.053258
        },
        {
          "period_end": "2030-12-31",
          "p_yes": 0.060358
        },
        {
          "period_end": "2031-03-31",
          "p_yes": 0.067875
        },
        {
          "period_end": "2031-06-30",
          "p_yes": 0.075798
        },
        {
          "period_end": "2031-09-30",
          "p_yes": 0.084116
        }
      ],
      "passes": []
    },
    {
      "question_id": "W242",
      "forecast_date": "2026-10-01",
      "evidence_cutoff": "2026-10-01",
      "method": "wide-v2.1",
      "opened": "2026-09-16",
      "linked_questions": [],
      "reading_adopted": "Approvals that rest on reliance on another substance's efficacy trials through PK/bioequivalence bridging, or on modelling used only for dose selection or animal-to-human translation, are treated as not meeting the computational-substitution requirement; only an explicit regulatory statement that model-generated efficacy predictions replace human efficacy-trial evidence counts.",
      "summary": null,
      "ambiguities": [],
      "key_drivers": [],
      "would_update_on": [],
      "forecasts": [
        {
          "period_end": "2026-09-30",
          "p_yes": 0.0002
        },
        {
          "period_end": "2026-12-31",
          "p_yes": 0.0006
        },
        {
          "period_end": "2027-03-31",
          "p_yes": 0.0011
        },
        {
          "period_end": "2027-06-30",
          "p_yes": 0.0016
        },
        {
          "period_end": "2027-09-30",
          "p_yes": 0.0022
        },
        {
          "period_end": "2027-12-31",
          "p_yes": 0.0028
        },
        {
          "period_end": "2028-03-31",
          "p_yes": 0.0035
        },
        {
          "period_end": "2028-06-30",
          "p_yes": 0.0042
        },
        {
          "period_end": "2028-09-30",
          "p_yes": 0.005
        },
        {
          "period_end": "2028-12-31",
          "p_yes": 0.0058
        },
        {
          "period_end": "2029-03-31",
          "p_yes": 0.0067
        },
        {
          "period_end": "2029-06-30",
          "p_yes": 0.0076
        },
        {
          "period_end": "2029-09-30",
          "p_yes": 0.0086
        },
        {
          "period_end": "2029-12-31",
          "p_yes": 0.0096
        },
        {
          "period_end": "2030-03-31",
          "p_yes": 0.0106
        },
        {
          "period_end": "2030-06-30",
          "p_yes": 0.0117
        },
        {
          "period_end": "2030-09-30",
          "p_yes": 0.0129
        },
        {
          "period_end": "2030-12-31",
          "p_yes": 0.0141
        },
        {
          "period_end": "2031-03-31",
          "p_yes": 0.0154
        },
        {
          "period_end": "2031-06-30",
          "p_yes": 0.0167
        },
        {
          "period_end": "2031-09-30",
          "p_yes": 0.018
        }
      ],
      "passes": []
    },
    {
      "question_id": "W242",
      "forecast_date": "2026-10-08",
      "evidence_cutoff": "2026-10-08",
      "method": "wide-v2.1",
      "opened": "2026-09-16",
      "linked_questions": [],
      "reading_adopted": null,
      "summary": "No medicine has ever been approved in the US or EU without any human test of whether it works, relying instead on computer simulations. Past approvals without human efficacy data relied on animal studies, which this question excludes. Current US and EU reforms speed up human trials or replace animal testing, but none replaces human efficacy trials. A formal US or EU pathway allowing approval on simulations alone would most change this forecast.",
      "ambiguities": [],
      "key_drivers": [],
      "would_update_on": [],
      "forecasts": [
        {
          "period_end": "2026-12-31",
          "p_yes": 0.0002
        },
        {
          "period_end": "2027-03-31",
          "p_yes": 0.0005
        },
        {
          "period_end": "2027-06-30",
          "p_yes": 0.0008
        },
        {
          "period_end": "2027-09-30",
          "p_yes": 0.0011
        },
        {
          "period_end": "2027-12-31",
          "p_yes": 0.0014
        },
        {
          "period_end": "2028-03-31",
          "p_yes": 0.0018
        },
        {
          "period_end": "2028-06-30",
          "p_yes": 0.0022
        },
        {
          "period_end": "2028-09-30",
          "p_yes": 0.0026
        },
        {
          "period_end": "2028-12-31",
          "p_yes": 0.003
        },
        {
          "period_end": "2029-03-31",
          "p_yes": 0.0035
        },
        {
          "period_end": "2029-06-30",
          "p_yes": 0.004
        },
        {
          "period_end": "2029-09-30",
          "p_yes": 0.0045
        },
        {
          "period_end": "2029-12-31",
          "p_yes": 0.005
        },
        {
          "period_end": "2030-03-31",
          "p_yes": 0.0056
        },
        {
          "period_end": "2030-06-30",
          "p_yes": 0.0062
        },
        {
          "period_end": "2030-09-30",
          "p_yes": 0.0068
        },
        {
          "period_end": "2030-12-31",
          "p_yes": 0.0074
        },
        {
          "period_end": "2031-03-31",
          "p_yes": 0.0081
        },
        {
          "period_end": "2031-06-30",
          "p_yes": 0.0088
        },
        {
          "period_end": "2031-09-30",
          "p_yes": 0.0095
        },
        {
          "period_end": "2031-12-31",
          "p_yes": 0.0102
        }
      ],
      "passes": []
    },
    {
      "question_id": "W242",
      "forecast_date": "2026-10-15",
      "evidence_cutoff": "2026-10-15",
      "method": "wide-v2.1",
      "opened": "2026-09-16",
      "linked_questions": [],
      "reading_adopted": null,
      "summary": "I put this at about 1% by the end of 2031. Neither the FDA nor the EU has ever approved a new drug without testing whether it works in people, and US law requires clinical studies. Every 2026 reform, including the AI-driven ones, aims for fewer or smaller human trials, not none. A formal regulatory pathway that accepts computer simulations instead of human efficacy trials would most change this forecast.",
      "ambiguities": [],
      "key_drivers": [],
      "would_update_on": [],
      "forecasts": [
        {
          "period_end": "2026-12-31",
          "p_yes": 0.0001
        },
        {
          "period_end": "2027-03-31",
          "p_yes": 0.0004
        },
        {
          "period_end": "2027-06-30",
          "p_yes": 0.0007
        },
        {
          "period_end": "2027-09-30",
          "p_yes": 0.0011
        },
        {
          "period_end": "2027-12-31",
          "p_yes": 0.0015
        },
        {
          "period_end": "2028-03-31",
          "p_yes": 0.002
        },
        {
          "period_end": "2028-06-30",
          "p_yes": 0.0025
        },
        {
          "period_end": "2028-09-30",
          "p_yes": 0.0031
        },
        {
          "period_end": "2028-12-31",
          "p_yes": 0.0037
        },
        {
          "period_end": "2029-03-31",
          "p_yes": 0.0044
        },
        {
          "period_end": "2029-06-30",
          "p_yes": 0.0051
        },
        {
          "period_end": "2029-09-30",
          "p_yes": 0.0058
        },
        {
          "period_end": "2029-12-31",
          "p_yes": 0.0065
        },
        {
          "period_end": "2030-03-31",
          "p_yes": 0.0073
        },
        {
          "period_end": "2030-06-30",
          "p_yes": 0.0081
        },
        {
          "period_end": "2030-09-30",
          "p_yes": 0.0089
        },
        {
          "period_end": "2030-12-31",
          "p_yes": 0.0097
        },
        {
          "period_end": "2031-03-31",
          "p_yes": 0.0105
        },
        {
          "period_end": "2031-06-30",
          "p_yes": 0.0114
        },
        {
          "period_end": "2031-09-30",
          "p_yes": 0.0123
        },
        {
          "period_end": "2031-12-31",
          "p_yes": 0.0132
        }
      ],
      "passes": []
    }
  ],
  "declined": []
}