Approval Timelines for Advanced Therapeutics in Inflammatory Bowel Disease: A Comparison Between the European Medicines Agency and the Food and Drug Administration
Bibliographic record
Abstract
Journal Article Corrected proof Approval Timelines for Advanced Therapeutics in Inflammatory Bowel Disease: A Comparison Between the European Medicines Agency and the Food and Drug Administration Get access Jurij Hanzel, MD, PhD, Jurij Hanzel, MD, PhD Department of Gastroenterology and Hepatology, University Medical Center Ljubljana, University of Ljubljana, Ljubljana, SloveniaAlimentiv Inc, London, ON, Canada https://orcid.org/0000-0003-3158-8014 Search for other works by this author on: Oxford Academic PubMed Google Scholar Christopher Ma, MD, MPH, Christopher Ma, MD, MPH Department of Community Health Sciences, University of Calgary, Calgary, AB, CanadaAlimentiv Inc, London, ON, CanadaDivision of Gastroenterology & Hepatology, Department of Medicine, University of Calgary, Calgary, AB, Canada https://orcid.org/0000-0002-4698-9948 Search for other works by this author on: Oxford Academic PubMed Google Scholar Theshani Amalka De Silva, MD, Theshani Amalka De Silva, MD Schulich School of Medicine and Dentistry, Western University, London, ON, Canada Search for other works by this author on: Oxford Academic PubMed Google Scholar Lotus Alphonsus, MD, Lotus Alphonsus, MD Schulich School of Medicine and Dentistry, Western University, London, ON, Canada Search for other works by this author on: Oxford Academic PubMed Google Scholar Leonardo Guizzetti, PhD, Leonardo Guizzetti, PhD Independent statistical consultant, London, ON, Canada Search for other works by this author on: Oxford Academic PubMed Google Scholar Eileen Crowley, MD, PhD, Eileen Crowley, MD, PhD Division of Pediatric Gastroenterology and Hepatology, Department of Pediatrics, Children's Hospital Western Ontario, Western University, London, ON, CanadaAlimentiv Inc, London, ON, Canada https://orcid.org/0000-0002-9545-4384 Search for other works by this author on: Oxford Academic PubMed Google Scholar Siddharth Singh, MD, Siddharth Singh, MD Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA https://orcid.org/0000-0002-2640-7269 Search for other works by this author on: Oxford Academic PubMed Google Scholar Vipul Jairath, MD, PhD Vipul Jairath, MD, PhD Department of Epidemiology and Biostatistics, Western University, London, ON, CanadaAlimentiv Inc, London, ON, CanadaDivision of Gastroenterology, Department of Medicine, Western University, London, ON, Canada Address correspondence to: Vipul Jairath, MBChB, DPhil, Department of Medicine, Division of Gastroenterology, Department of Epidemiology and Biostatistics, Western University, Suite 200, 100 Dundas Street, London, Ontario, N6A 5B6, Canada (vjairath@uwo.ca). https://orcid.org/0000-0002-1092-0033 Search for other works by this author on: Oxford Academic PubMed Google Scholar Inflammatory Bowel Diseases, izad168, https://doi.org/10.1093/ibd/izad168 Published: 17 August 2023 Article history Received: 03 May 2023 Editorial decision: 26 July 2023 Corrected and typeset: 17 August 2023 Published: 17 August 2023
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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 | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| 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; a candidate call from one teacher head, 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".