Phase 1 Study to Evaluate the PK, Safety, Tolerability of BIIB023 in Chinese, Japanese, and Caucasian Healthy Volunteers

Model scores of the 29,894 trials active now.

Model score 4% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 5% of the time (4,470 trials).

Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2012-02-29. 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.

• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: priorcellstudy treatmentdiseaseenrollment
  Phrases that lowered it: healthyvolunteersjapanesesinglealcohol
• Accepts healthy volunteers: Yes (lowers risk) · Who can join
• Sponsor's past termination rate: 23.5% (raises risk) · Sponsor's track record
• Phase: 1 (lowers risk) · Design
• Primary purpose: basic science (lowers risk) · Design
• Design: parallel (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 39 (lowers risk) · Sponsor's track record
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Has a data monitoring committee: No (lowers risk) · Design
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Disease area, cancer: No (lowers risk) · Disease area
• Number of arms: 6 (lowers risk) · Design
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Maximum age: 55 (lowers risk) · Who can join
• Sponsor's past trials: 102 (lowers risk) · Sponsor's track record
• Disease area, neurology: No (lowers risk) · Disease area
• Minimum age: 18 (raises risk) · Who can join

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.

• Single Ascending Doses of BIIB063 in Healthy Volunteers NCT02555085 · started 2015 · scored riskier than 3% of active trials terminated
• Evaluating the Safety, Tolerability, and Pharmacokinetics of BIIB095 in Healthy Participants NCT03454126 · started 2018 · scored riskier than 11% of active trials completed
• Pharmacokinetics, Safety and Tolerability of Single Doses of BIIB033 (Opicinumab) Produced by 2 Manufacturing Processes NCT02833142 · started 2016 · scored riskier than 3% of active trials completed
• A Study to See How BIIB122 Works in the Human Body, and to Evaluate it's Safety, and Tolerability in Healthy Adult Japanese, Chinese, and Caucasian Participants NCT05229562 · started 2022 · scored riskier than 4% of active trials completed
• Safety, Tolerability, and Pharmacokinetics of Single Doses of BIIB059 in Healthy Japanese Subjects. NCT03224793 · started 2017 · scored riskier than 4% 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.