Statistical review of Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial
Bibliographic record
Abstract
The following review has been prepared in collaboration with members of the MRC-NIHR Trials Methodology Research Partnership. The reviewers named above, and other, unnamed discussants of the paper, are all qualified statisticians with experience in clinical trials. Our objective is to provide a rapid review of publications, preprints and protocols from clinical trials of COVID-19 treatments, independent of journal specific review processes. We aim to provide timely, constructive, focused, clear advice aimed at improving both the research outputs under review, as well as future studies. Given our collective expertise (clinical trial statistics) our reviews focus on the designs of the trials and other statistical content (methods, presentation and accuracy of results, inferences). This review reflects the expert opinions of the named authors, and does not imply endorsement by the MRC-NIHR Trials Methodology Research Partnership, its wider membership, or any other organization. Here we review Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial by Wang et al, which was published in The Lancet, April 29, 2020. Overall, this was a well-conducted, well-reported trial, which was faithful to a pre-registered, openly available study protocol. Our comments on the paper, detailed below, are all minor in nature. The trial ended early, roughly half-way to its planned sample size, once successful infection control efforts in the region made it difficult to recruit new patients. It is perhaps not surprising then that the study did not demonstrate any substantial effects of remdesivir, though the authors correctly noted that the study was too small to rule out potentially important effects. Regardless, it will be important for investigators and decision makers to take data from this study into account as our understanding of COVID-19 treatment grows.
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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 | 0.125 | 0.372 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.007 | 0.011 |
| Bibliometrics | 0.006 | 0.006 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.006 | 0.003 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.004 | 0.004 |
| Insufficient payload (model declined to judge) | 0.006 | 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; 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".