Generation of Biological Samples Positive to Somatropin for Anti-doping Control
Model scores of the 29,894 trials active now.
Model score 3% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 11% of the time (918 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2020-01-08, after 2019-10-25 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 2020-01-08. 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
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: acutechronicevidencegrowthfailure
Phrases that lowered it: healthyvolunteersthe trialinvestigatorday -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Primary purpose: other (lowers risk) · Design
-
Sponsor's past termination rate: 1.7% (lowers risk) · Sponsor's track record
-
Phase: 1 (lowers risk) · Design
-
Minimum age: 20 (lowers risk) · Who can join
-
Drug's FAERS reports marked serious: 39.3% (lowers risk) · Drug's FDA history
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
-
Drug's FAERS reports with a death: 3.6% (lowers risk) · Drug's FDA history
-
Trials the sponsor started in the prior 2 years: 23 (lowers risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Has a data monitoring committee: No (lowers risk) · Design
-
Sponsor's past trials: 58 (lowers risk) · Sponsor's track record
-
Drug's FAERS reports before start: 23892 (raises risk) · Drug's FDA history
-
Disease area, psychiatry: No (lowers risk) · Disease area
-
Disease area, neurology: No (lowers risk) · Disease area
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
- 1 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- other (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 20 (typical: 18)
- Maximum age
- 30 (typical: 71)
- Sex
- male (typical: all)
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 58 (typical: 32)
- Sponsor's past termination rate
- 1.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 23 (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
- 23892 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 4506 (typical: 412.5)
- Drug's FAERS reports marked serious
- 39.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 3.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- somatropin
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
- Generation of Biological Samples Positive to Salmeterol for Anti-Doping Control NCT04195867 · started 2018 · scored riskier than 2% of active trials completed
- r-hGH Liquid Multidose Versus Freeze-dried Multidose Bioequivalence Trial NCT01034735 · started 2008 · scored riskier than 0% of active trials completed
- Generation of Biological Samples Positive to Hydrochlorothiazide for Anti-doping Control NCT04197622 · started 2019 · scored riskier than 2% of active trials completed
- A Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone Deficiency NCT04615273 · started 2020 · scored riskier than 15% of active trials completed
- A Trial to Investigate the Bioequivalence of Norditropin® (Somatropin) Versus Genotropin® (Somatropin) in Healthy Adult Subjects NCT01943084 · started 2013 · scored riskier than 0% 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.