Screen failure rates in contemporary phase II/III therapeutic trials in genitourinary malignancies.
Bibliographic record
Abstract
176 Background: Screen failures cost effort, time and resources estimated at about $2000 per patient (Bienkowski RS et al 2008). There is little published data about the frequency or causes of screen failures in genitourinary (GU) cancer clinical trials. Methods: We reviewed published articles and contacted study investigators on 42 key phase 2 and 3 trials in advanced GU cancer run from 1999 to 2015. We sought data on the numbers and causes of screen failures. Screen failures were defined as individuals who underwent screening but were not enrolled in the trial. Results: Among all 11 phase 3 trials in prostate cancer, the mean screen failure rate was 25% (17.9%-30.3%). In 4 recent trials evaluating novel androgen receptor pathway targeted agents, abiraterone and enzalutamide before or after chemotherapy for castration-resistant disease, the mean screen failure rate was 28% (range 22% to 30%). Only 2 of 3 prostate cancer chemotherapy trials completed after 2008 collected screen failure data with screen failure rates of 18 and 21%. The main reason for screen failures among all prostate cancer clinical trials was ineligibility. Among 14 phase 3 trials in kidney cancer, 5 reported rates and the mean screen failure rate was 24% (range 21%-27%). The main reasons again were ineligibility, with a very small percentage due to patient refusal. Among 17 phase 2 or 3 trials in bladder cancer, 6 reported rates and the mean screen failure rate was 13% (range 2.04% - 22.8%). The main reasons were primarily ineligibility and patient refusal to a lesser extent. Only (16/42) 38% of the trials published screen failure rates-73% of those in prostate cancer (all completed after 2008), 29% in kidney cancer, and 24% in bladder cancer. Conclusions: Contemporary trials in GU cancer that collected screen failure data had fairly consistent failure rates of 20-30% in prostate and kidney cancer. Many trials did not collect data on the numbers of and reasons for screen failures. Greater standardization of definitions, methods and reporting are needed to better understand and improve screen failure rates in GU cancer trials.
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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 | 0.157 | 0.269 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.004 |
| Bibliometrics | 0.006 | 0.007 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.004 | 0.004 |
| Open science | 0.001 | 0.002 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 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".