GalenOps prod · 0.1.0

Agent

Feasibility assessed

Horizon 1 feasibility_agent

Can this study realistically enroll — sites, patients, timeline?

Escalates: Low-feasibility assessments (predicted enrollment shortfall or termination-risk red flags), as a medium-priority review task — to the clinical operations lead.

Agents

Runs

3

Escalations

0

Failures

0

Avg duration

4.0 s

Literature & benchmarks

  • Zhang & DuBois 2023 — odds ratios for early termination by funding source, phase and design, applied as the risk prior
  • Dombernowsky et al. 2019 — site recruitment forecasts overshoot; projections are discounted accordingly
  • ClinicalTrials.gov API v2 — comparator trials in the same indication and phase for enrollment and duration benchmarks

Run history (3 across all studies)

Newest first, 50 per page. Expand a row for the recorded reasoning and evidence.

Expand When Study Outcome Model Duration Reasoning
2026-09-29 23:42 UTC A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma completed claude-sonnet-5 4.6 s This study is assessed as feasible (score 1.0): target enrollment of 105 was already reached, with 126 consented across 34 contracted sites in 7 countries (AUS, HUN, IND, ROU, RUS, UKR, USA). Demand was 0.1716 per site-month against observed capacity (λ) of 0.1379, based on 126 accrued over 913.8 site-months (Dombernowsky 2019: observed accrual replaces assumed rate), giving burden 1.2443. A narrow funnel is flagged because assumed capacity λ 0.0375 is below the 0.05 threshold, driven by 3 restrictive criteria (treatment-naïve/prior-therapy exclusion, ECOG limit, organ-function thresholds) yielding a screen-pass fraction of 0.125. Termination-risk multiplier: phase II OR 1.58 (Zhang & DuBois 2023, product 1.58). ClinicalTrials.gov comparator (soft tissue sarcoma, phase 2, n=1344): terminated_rate 0.1168, accrual_terminated_rate 0.0432, median enrollment 42. No review was opened; no human decision is requested here.
2026-09-29 21:13 UTC A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer completed claude-sonnet-5 3.6 s This trial scores 0.52 — feasible with mitigation. Demand is 1.5789 patients per site-month against a capacity of 1.7043 (observed accrual, replacing the assumed rate per Dombernowsky 2019), giving a burden of 0.9264, close to capacity. With 317 of 450 accrued, 133 remain, and 6.0 months are left in the 19-month plan; at the observed pace (lambda 1.7043) this would take about 5.2 months, so timing looks workable but tight. The suggested mitigation is loosening the treatment-naïve/prior-therapy exclusion criterion to double the screen-pass fraction. Zhang & DuBois 2023 indicates no published termination-risk multipliers apply given industry funding, phase 3, and 13 countries. The ClinicalTrials.gov comparator (non-small cell lung cancer, phase 3, n=1025) shows 11.5% terminated overall, 3.1% for accrual, median enrollment 375. No review was opened and no human decision is requested at this time.
2026-09-19 08:58 UTC A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer completed claude-sonnet-5 3.9 s This trial is assessed as feasible with mitigation. Demand is 1.5789 patients per site-month against an observed capacity of 1.7043 per site-month, giving a burden of 0.9264 — close to capacity, as noted in the recommendation. With 317 of 450 accrued, 133 remain, and 6.0 months remain against a projected 5.2 months to finish at the observed pace, suggesting timeline feasibility if accrual holds. No termination-risk multipliers applied (industry-funded, phase 3, 13 countries, per Zhang & DuBois 2023, citing 22.7% terminated overall, 34.5% of terminations due to accrual). The ClinicalTrials.gov comparator (NSCLC, phase 3, n=1025) shows 11.5% terminated, 3.1% for accrual, median enrollment 375, and comparator_flag is false. Score is 0.52; no review was opened, so no human decision is required at this time.