Reporting Clinical Trials: Full Access to All the Data
Bibliographic record
Abstract
Biomedical research is becoming more complex as a result of involvement by individual investigators, universities, commercial research units and industry.Financial conflicts of interest have been the subject of many editorials, and most peer-reviewed journals now require any conflicts to be identified and explained when authors submit manuscripts for publication.Clear statements of industry sponsored research and author participation in corporate activities are required for evaluation of a manuscript.Full disclosure of financial interests by authors is essential to retain public trust in biomedical research, the peerreview process and the integrity of the authors and of the universities.1 We already require that each author sign a statement of his or her financial arrangements with public, private and industry sources of support.These declarations alert the editor, reviewer and physician-reader to any potential bias in the interpretation and presentation of the data.Patients' lives may depend on an accurate and complete understanding of how and why authors obtained facts relating to therapies.Nonfinancial conflicts of interest between authors and corporate sponsors are of equal concern and require our attention.These include the need for an open and candid relationship between authors and the policies of the sponsoring companies with regard to academic freedom.Issues of control and complete access to all data, conduct of statistical studies and analyses, manuscript preparation, and decisions to publish are of increasing importance and concern.Corporate sponsors must not be allowed to influence publication, or indeed to prevent it, especially when the data are not supportive of their product.Authors, editors and industry sponsors are aware of these matters and it is now time to address them. 1 These issues have been addressed in recent editorials in JAMA and The New England Journal of Medicine.The editors of JAMA, The New England Journal of Medicine, Canadian Medical Association Journal, Journal of the Danish Medical Association, The Lancet, MEDLINE/Index Medicus, New Zealand Medical Journal, Journal of the Norwegian Medical Association, Dutch Journal of Medicine, Annals of Internal Medicine, Medical Journal of Australia and the Western Journal of Medicine have all agreed to require authors to disclose details of their own and the sponsor's role in the study.2 Authors will be required to sign a statement indicating that they accept full responsibility for the conduct of the study, had access to all the data and had the authority to publish it.An amendment was made allowing the sponsor up to 60 days to review a manuscript before publication to allow for the filing of additional patent protection, if necessary.These policies will also be incorporated into the next revision of "Uniform Requirements for Manuscripts Submitted to Biomedical Journals".3
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 | 0.208 | 0.634 |
| Meta-epidemiology (narrow) | 0.006 | 0.008 |
| Meta-epidemiology (broad) | 0.026 | 0.009 |
| Bibliometrics | 0.035 | 0.034 |
| Science and technology studies | 0.002 | 0.005 |
| Scholarly communication | 0.020 | 0.018 |
| Open science | 0.009 | 0.013 |
| Research integrity | 0.013 | 0.009 |
| Insufficient payload (model declined to judge) | 0.363 | 0.310 |
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".