Extension Study to PTR-01-002 (A Study in Recessive Dystrophic Epidermolysis Bullosa (RDEB) Patients Previously Treated With PTR-01)

Model scores of the 29,894 trials active now.

Model score 11% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 6% of the time (240 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 2022-08-09. 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% (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) (lowers risk) · Wording Phrases that raised it: of studytherapydose ofinvestigationalstudy drug
  Phrases that lowered it: consent formthe trialparticipatedagreesscreening
• Drug's FAERS reports marked serious: 54.3% (lowers risk) · Drug's FDA history
• Disease area, cancer: No (lowers risk) · Disease area
• Drug's FAERS reports with a death: 1.3% (lowers risk) · Drug's FDA history
• Design: single group (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Has a data monitoring committee: No (lowers risk) · Design
• Primary purpose: treatment (raises risk) · Design
• Disease area, dermatology: Yes (raises risk) · Disease area
• Blinding: none (raises risk) · Design
• Number of arms: 1 (raises risk) · Design
• Maximum age: not given (raises risk) · Who can join
• Disease area, neurology: No (lowers risk) · Disease area
• Collaborators: 1 (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.

• A Study of PTR-01 in Recessive Dystrophic Epidermolysis Bullosa NCT04599881 · started 2020 · scored riskier than 51% of active trials completed
• A Phase 1/2 Trial of PTR-01 in Adult Patients With Recessive Dystrophic Epidermolysis Bullosa (RDEB) NCT03752905 · started 2019 · scored riskier than 15% of active trials completed
• Allogeneic ABCB5-positive Stem Cells for Treatment of Epidermolysis Bullosa NCT03529877 · started 2019 · scored riskier than 47% of active trials completed
• Long Term Open-label Study Evaluating Safety of Diacerein 1% Ointment Topical Formulation in Subjects With Epidermolysis Bullosa Simplex NCT03389308 · started 2017 · scored riskier than 50% of active trials completed
• Open-Label Extension Study to Evaluate the Safety of SD-101 Cream in Participants With Epidermolysis Bullosa NCT02090283 · started 2014 · scored riskier than 41% of active trials terminated

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.