Physicians' perspective on the clinical meaningfulness of inflammatory bowel disease trial results : an International Organization for the Study of Inflammatory Bowel Disease (IOIBD) survey
© 2018 John Wiley & Sons Ltd..
BACKGROUND: Several novel compounds are being developed for inflammatory bowel diseases (IBD). In addition, biosimilar drugs are being approved. An increasing number of head-to-head, superiority and non-inferiority trials in patients with IBD are expected in the future. The clinical relevance of the magnitude of the effect size is often debated.
AIM: To better understand physicians' perspectives on the clinical meaningfulness of IBD trial results.
METHODS: We conducted an online survey among all IOIBD (International Organization for the Study of Inflammatory Bowel Diseases) members, asking their opinion on the clinical relevance of the results of IBD trials.
RESULTS: Forty-six IOIBD members responded to the survey (52.3%). In biologic-naïve ulcerative colitis (UC) and Crohn's disease (CD) patients, most of the participants considered a 15% difference with placebo for clinical remission and endoscopic remission to be clinically relevant. In head-to-head trials, most of participants considerer a 10% difference between groups for clinical remission and endoscopic remission to be clinically relevant. Half of respondents considered 10% to be an adequate margin in non-inferiority trials. In bioequivalence studies, most of the participants considered adequate a ± 5% difference between a biosimilar and the originator for pharmacokinetic parameters, efficacy, safety and immunogenicity. Regarding safety, the difference between two drugs considered clinically relevant varied from 1% to 5%, depending on the type of adverse event.
CONCLUSIONS: This is the first survey exploring how physicians perceive IBD trial results, providing an estimation of the magnitude of the difference between treatment arms that may directly influence clinical practice.
| Errataetall: |
CommentIn: Aliment Pharmacol Ther. 2018 Apr;47(7):1032-1033. - PMID 29512917 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2018 |
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| Erschienen: |
2018 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:47 |
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| Enthalten in: |
Alimentary pharmacology & therapeutics - 47(2018), 6 vom: 25. März, Seite 773-783 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Olivera, P [VerfasserIn] |
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| Anmerkungen: |
Date Completed 12.06.2019 Date Revised 13.06.2019 published: Print-Electronic CommentIn: Aliment Pharmacol Ther. 2018 Apr;47(7):1032-1033. - PMID 29512917 Citation Status MEDLINE |
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| doi: |
10.1111/apt.14514 |
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| funding: |
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| PPN (Katalog-ID): |
NLM280116500 |
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| 500 | |a Date Revised 13.06.2019 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a CommentIn: Aliment Pharmacol Ther. 2018 Apr;47(7):1032-1033. - PMID 29512917 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2018 John Wiley & Sons Ltd. | ||
| 520 | |a BACKGROUND: Several novel compounds are being developed for inflammatory bowel diseases (IBD). In addition, biosimilar drugs are being approved. An increasing number of head-to-head, superiority and non-inferiority trials in patients with IBD are expected in the future. The clinical relevance of the magnitude of the effect size is often debated | ||
| 520 | |a AIM: To better understand physicians' perspectives on the clinical meaningfulness of IBD trial results | ||
| 520 | |a METHODS: We conducted an online survey among all IOIBD (International Organization for the Study of Inflammatory Bowel Diseases) members, asking their opinion on the clinical relevance of the results of IBD trials | ||
| 520 | |a RESULTS: Forty-six IOIBD members responded to the survey (52.3%). In biologic-naïve ulcerative colitis (UC) and Crohn's disease (CD) patients, most of the participants considered a 15% difference with placebo for clinical remission and endoscopic remission to be clinically relevant. In head-to-head trials, most of participants considerer a 10% difference between groups for clinical remission and endoscopic remission to be clinically relevant. Half of respondents considered 10% to be an adequate margin in non-inferiority trials. In bioequivalence studies, most of the participants considered adequate a ± 5% difference between a biosimilar and the originator for pharmacokinetic parameters, efficacy, safety and immunogenicity. Regarding safety, the difference between two drugs considered clinically relevant varied from 1% to 5%, depending on the type of adverse event | ||
| 520 | |a CONCLUSIONS: This is the first survey exploring how physicians perceive IBD trial results, providing an estimation of the magnitude of the difference between treatment arms that may directly influence clinical practice | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 700 | 1 | |a Sandborn, W J |e verfasserin |4 aut | |
| 700 | 1 | |a Panés, J |e verfasserin |4 aut | |
| 700 | 1 | |a Baumann, C |e verfasserin |4 aut | |
| 700 | 1 | |a D'Haens, G |e verfasserin |4 aut | |
| 700 | 1 | |a Vermeire, S |e verfasserin |4 aut | |
| 700 | 1 | |a Danese, S |e verfasserin |4 aut | |
| 700 | 1 | |a Peyrin-Biroulet, L |e verfasserin |4 aut | |
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