Representativeness of oncology clinical trials in Alberta.
Bibliographic record
Abstract
27 Background: The Institute of Medicine encourages broad participation by patients in clinical trials to “efficiently provide practice-changing evidence”. Enrolment of a representative sample of the general oncology population in clinical trials is essential to ensure that outcomes are generalizable and to ensure equity and social justice. Our aims were to 1) determine the characteristics of all cancer patients compared to those enrolled on a clinical trial and 2) to determine factors and outcomes associated with clinical trial participation. Methods: We assembled a large cohort of patients diagnosed with all solid malignancies between 2004 and 2016 in a large Canadian province. We collected information on age, sex, tumor type, Charlson comorbidity index (CCI), year of diagnosis, treatment type (surgery, chemo, radiation, and immunotherapy). Logistic regression was used to identify factors associated with clinical trial participation. Cox regression models were constructed to determine overall survival (OS). Results: We identified 146,294 patients with a cancer diagnosis, of which 43% were men and the mean age at diagnosis was 61 years (SD 15.6). Approximately 3% (4,364/146,294) of all patients were enrolled in a clinical trial. Baseline characteristics showed that clinical trial patients were younger (mean age 58 years vs 61 years), had fewer comorbidities (CCI 0 = 83% vs. 73%) and more often male (45% vs 43%). Compared to all patients, clinical trial patients were more likely to be younger (OR 0.98, p < 0.001), male (OR 1.21, 95% CI 1.10-1.32 p < 0.001), and to have a diagnosis of brain (OR 3.8, 95% CI 2.86-5.05, p < 0.001), kidney (OR 2.61, 95% CI 1.93-3.52) or breast cancer (OR 2.38, 95% CI 1.84-3.08). Compared to all patients and those not treated on clinical trial, patients on clinical trial had improved OS (HR 0.81, 95% CI 0.77-0.85, p < 0.001). Conclusions: Only a small proportion of real world patients are treated within a clinical trial. Characteristics of clinical trials patients are significantly different from all patients with cancer. More representative clinical trials are needed in order to reflect the real world cancer population.
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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 | 0.082 | 0.146 |
| Meta-epidemiology (narrow) | 0.000 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.005 | 0.009 |
| Science and technology studies | 0.002 | 0.002 |
| Scholarly communication | 0.003 | 0.001 |
| Open science | 0.003 | 0.003 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.008 | 0.001 |
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; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
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".