What information should a sponsor of a randomized trial receive during its conduct?
Bibliographic record
Abstract
BACKGROUND: The relationship and roles among the steering committee, the Data Safety Monitoring Board (DSMB), and the sponsor of a randomized clinical trial (RCT) must be carefully defined to ensure the integrity of the trial. PURPOSE: We present an unusual scenario that arose during the conduct of a large RCT in Canada that involved the relationship of the steering committee and the DSMB with the peer review sponsor. METHODS: Case study of a large RCT conducted in Canada and a commentary on the roles and responsibilities of the steering committee, DSMB, and sponsor. CONCLUSIONS: This case illustrates the need for funding agencies to understand the importance of respecting the independence of the DSMB and the need to keep confidential emerging trends regarding study results, including the conditional probability, during the conduct of a trial.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.664 | 0.827 |
| Meta-epidemiology (narrow) | 0.001 | 0.002 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.007 | 0.025 |
| Scholarly communication | 0.011 | 0.018 |
| Open science | 0.005 | 0.004 |
| Research integrity | 0.038 | 0.028 |
| Insufficient payload (model declined to judge) | 0.003 | 0.002 |
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".