Roflumilast as add-on Therapy in Early Cases of ARDS

Model scores of the 29,894 trials active now.

Model score 12% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 21% of the time (143 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2022-01-01. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

• Sponsor's past termination rate: 0.8% (lowers risk) · Sponsor's track record
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 2 (raises risk) · Design
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: breastpatientstherapyprotocolstandard
  Phrases that lowered it: respiratorycopdmalemildinflammatory
• Trials the sponsor started in the prior 2 years: 564 (raises risk) · Sponsor's track record
• Blinding: single (lowers risk) · Design
• Design: parallel (raises risk) · Design
• Responsible party: principal investigator (lowers risk) · Design
• Has a data monitoring committee: Yes (raises risk) · Design
• Drug's FAERS reports with a death: 11.7% (lowers risk) · Drug's FDA history
• Disease area, cancer: No (lowers risk) · Disease area
• Minimum age: 18 (raises risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Sponsor type: academic or other (raises risk) · Sponsor's track record
• Sponsor's past trials: 524 (raises risk) · Sponsor's track record
• Number of arms: 2 (raises risk) · Design
• Maximum age: 65 (lowers risk) · Who can join
• Drug's FAERS reports marked serious: 68.9% (lowers risk) · Drug's FDA history
• Collaborators: 0 (raises risk) · Design

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

• Effects of Roflumilast in Hospitalized Chronic Obstructive Pulmonary Disease( COPD) on Mortality and Re-hospitalization NCT01973998 · started 2013 · scored riskier than 30% of active trials completed
• Effect of Roflumilast at Acute Exacerbations of Chronic Obstructive Pulmonary Disease NCT01473758 · started 2012 · scored riskier than 31% of active trials terminated
• A Multicenter Randomized Double-blind Clinical Study Evaluated the Safety, Pharmacokinetic and Pharmacodynamic Characteristics of Roflumilast in COPD Patients NCT02671942 · started 2016 · scored riskier than 16% of active trials terminated
• A Combination of an Inhaled Budesonide and Ipratropium in Patients at Risk of Developing ARDS NCT06657079 · started 2024 · scored riskier than 62% of active trials completed
• Roflumilast or Azithromycin to Prevent COPD Exacerbations Trial NCT04069312 · started 2020 · scored riskier than 19% of active trials completed

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.