Pharmaco-economic Study of a New Medical Device Performed From the Perspective of the Hospital

NCT01426295 on ClinicalTrials.gov Phase 2 Nantes University Hospital (academic or other) Started 2011-04-30 Completed

Riskier than 64% of active trials

Model scores of the 29,894 trials active now.

Model score 19% for any early termination, 12% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 30% of the time (107 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.

How it ended

Completed on 2014-04-30, after 2011-04-30 start.

The score above never used this outcome: 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.

Termination over time, as the model saw it at the start

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2014-04-30. 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.

What moved the score

Sponsor's past termination rate: 34.2% (raises risk) · Sponsor's track record
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: lymphomapatientsmarrowchemotherapypatient
Phrases that lowered it: oralproductsmyelomaseverehistory
Accepts healthy volunteers: No (raises risk) · Who can join
Primary purpose: not given (lowers risk) · Design
Phase: 2 (raises risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Trials the sponsor started in the prior 2 years: 33 (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports with a death: 13.1% (lowers risk) · Drug's FDA history
Minimum age: 18 (raises risk) · Who can join
Number of arms: 2 (raises risk) · Design
Drug's FAERS reports marked serious: 85.6% (raises risk) · Drug's FDA history

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.

The trial

Design

Phase: 2
Number of arms: 2
Allocation: randomized
Design: parallel
Primary purpose: not given (typical: treatment)
Blinding: none
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 1 (typical: 0)
Keywords listed: 1

Who can join

Minimum age: 18
Maximum age: not given (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 38 (typical: 32)
Sponsor's past termination rate: 34.2% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 33 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 1
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 33020 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 8803 (typical: 412.5)
Drug's FAERS reports marked serious: 85.6%
Drug's FAERS reports with a death: 13.1% (typical: 15.9%)

Disease area and drugs

Disease areas: hematology
Drugs matched to FDA substances: bicarbonate

Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.

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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.