Burdensome Research Procedures in Trials: Why Less Is More
Bibliographic record
Abstract
A large volume of trials involve invasive, nontherapeutic research procedures, like organ biopsy or sham surgeries, that can pose risks comparable with the experimental treatment itself but that have no direct benefit for volunteers. Though such procedures can enhance the value of clinical investigations, recent studies suggest that many studies involving invasive, nontherapeutic research procedures are not well planned and reported; some studies suggest that their results are often not utilized in the planning of new investigations. This commentary offers recommendations for how investigators, sponsors, and ethics committees might improve evaluation and implementation of studies involving invasive nontherapeutic procedures. We conclude by urging more demanding scientific standards for the rationale, design, and reporting of burdensome, nontherapeutic research procedures-particularly where they involve risk of serious complications.
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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 | 0.748 | 0.862 |
| Meta-epidemiology (narrow) | 0.003 | 0.004 |
| Meta-epidemiology (broad) | 0.009 | 0.006 |
| Bibliometrics | 0.007 | 0.006 |
| Science and technology studies | 0.007 | 0.071 |
| Scholarly communication | 0.030 | 0.053 |
| Open science | 0.011 | 0.014 |
| Research integrity | 0.045 | 0.058 |
| Insufficient payload (model declined to judge) | 0.006 | 0.003 |
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".