Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1)
Bibliographic record
Abstract
Registering of trials is essential to make sure all results are publicly available and that ethical obligations to participants are met Recent evidence of selective reporting of results has eroded public and academic confidence in publications of clinical trials, leading to renewed calls for trial registration.1–5 The dangers of non-disclosure of trial results, although described for years, sparked an international furore last spring after the publication of two systematic reviews on the effects of selective serotonin reuptake inhibitors for childhood depression.1 6 Subsequent legal proceedings7 and policy statements by journal editors,8 9 medical associations,10 and industry11 have recognised the importance of trial registration. The rationale for registering trials is well known (box 1).12 13 Most importantly, the contribution to social good that justifies research on human participants is not realised when resulting knowledge remains invisible. As an interested and neutral party that has been registering the trials that it funds,14 the Canadian Institutes of Health Research hosted an open meeting on 4 October 2004 in Ottawa, Canada, to foster international consensus on trial registration. The resulting Ottawa statement aims to establish internationally recognised principles for registration (box 2). The full statement is on bmj.com, but here we highlight and discuss some of the key principles. A statement on how to implement these principles (part 2) is still in development. The mandatory registration of all trials has three components: ### Box 1: Rationale for registration of clinical trials #### Ethical
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.129 | 0.032 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.001 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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; both teacher heads 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".