| Title: | Differences between the 2016 and 2022 food and drug administration guidance : implications for design and interpretation of clinical trials in ulcerative colitis |
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| Authors: | ID Hanžel, Jurij (Author)
ID Ma, Christopher (Author)
ID Peyrin-Biroulet, Laurent (Author)
ID Danese, Silvio (Author)
ID Sands, Bruce E (Author)
ID Jairath, Vipul (Author) |
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| Files: |  PDF - Presentation file, download (338,58 KB)
MD5: BDA6F79CD954814784D09550520DDF7B
 URL - Source URL, visit https://academic.oup.com/crohnscolitis360/article/6/2/otae038/7693369
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| Language: | English |
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| Typology: | 1.01 - Original Scientific Article |
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| Organization: |  UKC LJ - Ljubljana University Medical Centre
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| Abstract: | Background: In 2022, the Food and Drug Administration (FDA) updated its draft guidance for drug development in ulcerative colitis, replacing the version from 2016. Several changes from the 2016 version merit further discussion as they impact clinical trial design and the interpretation of trial results. Methods: We compared both documents and critically appraised the changes and implications for future clinical trials. Results: The 2022 guidance recommends full colonoscopy, rather than fexible sigmoidoscopy, to document disease activity in all involved segments of the colon. The concordance between the fndings of the 2 procedures is very high and there is little evidence to support colonoscopy over sigmoidoscopy. The use of colonoscopy, rather than sigmoidoscopy, is also associated with a higher burden to trial participants who must undergo full bowel preparation, cost, and a potential for more adverse events. The defnition of the Mayo endoscopic score of 0 was changed from the original publication to “normal appearance of mucosa,” which suggests that endoscopic signs of prior disease, such as pseudopolyps and scarring, are incompatible with a score 0, even though they are not associated with active disease. The term “mucosal healing” has been abolished and histologic outcomes defned as exploratory. A welcome change is that shorter washout periods than 5 half-lives will be considered to reduce patient exposure to corticosteroids as bridging therapy. Conclusions: The 2022 FDA draft guidance includes changes which for the most part are not informed by empirical evidence, which may ultimately complicate interpretation of future trials and preclude comparisons with past trials |
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| Keywords: | food guidance, drug guidence, differences |
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| Publication status: | Published |
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| Publication version: | Version of Record |
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| Year of publishing: | 2024 |
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| Number of pages: | str. 1-5 |
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| Numbering: | Vol. 6, iss. 2 |
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| PID: | 20.500.12556/DiRROS-29793  |
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| UDC: | 61 |
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| ISSN on article: | 2631-827X |
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| DOI: | 10.1093/crocol/otae038 |
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| COBISS.SI-ID: | 200322307 |
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| Note: | Nasl. z nasl. zaslona;
Opis vira z dne 1. 7. 2024;
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| Publication date in DiRROS: | 05.06.2026 |
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| Views: | 79 |
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| Downloads: | 64 |
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| Metadata: |    |
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