International central adjudication committee in the PLATO trial: independent body of experts or friendly family picnic?
Bibliographic record
Abstract
The International Central Adjudication Committee (ICAC) is responsible for blinded independent assessment of complex clinical events in randomized trials. In this study, we analyze the constituence and impact of the ICAC in the PLATO trial. The PLATO ICAC was entirely governed by two academic institutions, Duke Clinical Research Institute (DCRI) and Uppsala Clinical Research Center (UCRC). Both co-chairman, all coordinators and half of the adjudicators in the PLATO ICAC belonged to either DCRI or UCRC. Among the other adjudicators representing USA, Canada and Australia, majority had DCRI ties, including at least five former Duke cardiology fellows. Furthermore, both co-chairmen are listed as adjudicators, representing obvious conflict. In the PLATO trial, the sponsor representatives were involved in selecting the ICAC members. Finally, 21 out of the 50 adjudicators represented Sweden, the homeland of the PLATO sponsor and primary investigator. Heavy selection bias in the ICAC constituence, lack of independence and potential control of the ICAC by the study sponsor may influence PLATO outcomes, and should be avoided in the future.
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 | 0.263 | 0.524 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.006 | 0.004 |
| Bibliometrics | 0.003 | 0.005 |
| Science and technology studies | 0.004 | 0.007 |
| Scholarly communication | 0.011 | 0.008 |
| Open science | 0.005 | 0.003 |
| Research integrity | 0.020 | 0.023 |
| Insufficient payload (model declined to judge) | 0.007 | 0.004 |
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".