Study to Determine the Efficacy and Safety of a Novel Nicotine Replacement Therapy
Model scores of the 29,894 trials active now.
Model score 7% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 12% of the time (422 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2016-02-10, after 2015-01-31 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
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 2016-02-10. 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
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: diabetesstoppregnancypurposetherapy
Phrases that lowered it: and safetyefficacy andsmokingthe efficacysafety of -
Sponsor's past termination rate: 25% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 31.5% (lowers risk) · Drug's FDA history
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Phase: 3 (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports with a death: 2.9% (lowers risk) · Drug's FDA history
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Blinding: triple (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Has a data monitoring committee: No (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Sponsor's past trials: 4 (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Maximum age: 85 (raises risk) · Who can join
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Collaborators: 2 (lowers risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Number of arms: 2 (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.
The trial
Design
- Phase
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 2 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 85 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 4 (typical: 32)
- Sponsor's past termination rate
- 25% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 2 (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
- 23671 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1374 (typical: 412.5)
- Drug's FAERS reports marked serious
- 31.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 2.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry
- Drugs matched to FDA substances
- nicotine
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Early Effects of a New Oral Nicotine Replacement Product and NiQuitin™ Lozenge NCT01075659 · started 2010 · scored riskier than 8% of active trials completed
- Study to Determine if a New Nicotine Replacement Therapy Can Safely Help Smokers to Quit Smoking NCT01296698 · started 2011 · scored riskier than 16% of active trials terminated
- Effects of Random Nicotine Delivery on Smoking Cessation NCT03674970 · started 2019 · scored riskier than 7% of active trials completed
- Combination of Nicotine Replacement Therapy (NRT) and Varenicline to Increase Cessation of Tobacco (CONVICT Study) NCT01184664 · started 2011 · scored riskier than 7% of active trials completed
- Clinical Study of Smoke-Break Liquid Cigarettes NCT00715871 · started 2008 · scored riskier than 28% 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.