79MO Developing international consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding clinical trials: The DEFINE (DosE FIndiNg Extensions) study
Bibliographic record
Abstract
Early phase dose-finding (EPDF) trials are crucial for the development of a new intervention and influence whether it can be investigated in further trials. Guidance exists for clinical trial protocols and trial reports in the SPIRIT and CONSORT guidelines, respectively. The features of EPDF trials are not well addressed in both guidelines and their extensions. Building on the SPIRIT and CONSORT checklists, the DEFINE study aims to develop international consensus-driven guidelines for EPDF trial protocols and reports. The initial generation of candidate items was informed by reviewing published EPDF trial reports. The early draft items were further enriched via a review of the published and grey literature, real-world examples analysis, citation and reference searches and experts’ recommendations. Following a 2-round modified Delphi process, an international consensus meeting was held. The resultant SPIRIT-DEFINE and the CONSORT-DEFINE checklists are then piloted prior to being finalised. Tailored to cover the specific features of EPDF trials, the Delphi survey included new or modified candidate items for SPIRIT (n = 36) and CONSORT (n = 44) extensions. 206 interdisciplinary stakeholders participated in Round 1 from 24 countries, and 151 stakeholders in Round 2. The Delphi results and a subsequent consensus meeting led to the recommendation of 31 and 36 candidate items for the SPIRIT-DEFINE and CONSORT-DEFINE checklists respectively. New items added include starting dose and dosing regimens with rationale, dose [de-]escalation strategies and decision criteria. International stakeholders are currently testing the checklists, and their feedback will be integrated into the final guidelines. The SPIRIT-DEFINE and CONSORT-DEFINE guidelines will allow investigators to effectively address the essential items that should be present in EPDF trial protocols and their reporting of the results. These will promote transparency, completeness and reproducibility of methods and ultimately contribute to reducing research waste and enhancing patient care and safety.
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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 | 0.080 | 0.045 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.001 |
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".