Generalisability of pharmaceutical randomised controlled trial eligibility criteria for progressive pulmonary fibrosis
Bibliographic record
Abstract
BACKGROUND: Progressive pulmonary fibrosis (PPF) is of substantial interest for novel pharmacotherapy discovery, but little is known about clinical trial eligibility criteria. We evaluated eligibility criteria of PPF randomised controlled trials, their representativeness in registry patients, and forced vital capacity changes and mortality according to trial eligibility. METHODS: A systematic search was used to identify completed and in-progress phase 2 and 3 PPF randomised controlled trials. Common clinical trial eligibility criteria used in ≥60% of previous PPF randomised controlled trials were identified. The most common criteria for PPF used in randomised controlled trials ("trial-PPF criteria") and the clinical practice guideline definition of PPF ("guideline-PPF criteria") were both applied to patients enrolled in a prospective multicentre Canadian registry. Common trial eligibility criteria were tested for their frequency and association with health outcomes in registry patients who met trial-PPF and guideline-PPF criteria. RESULTS: 10 different definitions of PPF were used in 16 randomised controlled trials. At the time of meeting PPF definitions, 50% of 864 patients with trial-PPF and 44% of 408 patients with guideline-PPF met the common trial eligibility criteria. For both definitions, trial-eligible patients had more rapid 1-year decline in forced vital capacity but better transplant-free survival than trial-ineligible patients. Patients with unclassifiable interstitial lung disease had a higher proportion of trial exclusion compared to those with connective tissue disease-associated interstitial lung disease and fibrotic hypersensitivity pneumonitis. Annual forced vital capacity decline (trial-PPF: -67 to -21 mL; guideline-PPF: -116 to -41 mL) and 1-year transplant-free survival (trial-PPF: 90.5-97.5%; guideline-PPF: 87-96.2%) varied in trial-eligible patients across interstitial lung disease subtypes. CONCLUSIONS: Existing randomised controlled trials use a variety of definitions for PPF with eligibility criteria that have limited representativeness. Forced vital capacity decline and transplant-free survival vary according to trial eligibility and interstitial lung disease subtypes.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.646 | 0.832 |
| Meta-epidemiology (narrow) | 0.004 | 0.004 |
| Meta-epidemiology (broad) | 0.016 | 0.036 |
| Bibliometrics | 0.014 | 0.014 |
| Science and technology studies | 0.003 | 0.013 |
| Scholarly communication | 0.009 | 0.009 |
| Open science | 0.009 | 0.007 |
| Research integrity | 0.014 | 0.007 |
| Insufficient payload (model declined to judge) | 0.022 | 0.005 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; the direct Gemma label and the distilled Codex classifier agree on what is shown here.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".