Basket, Umbrella, and Platform Trials: The Potential for Master Protocol–Based Trials in Inflammatory Bowel Disease

Honap, Sailish; Sands, Bruce E.; Jairath, Vipul; Danese, Silvio; Vicaut, Eric; Peyrin-Biroulet, Laurent

doi:10.1053/j.gastro.2024.04.020

Gastroenterology

2024

DOI: 10.1053/j.gastro.2024.04.020

|View full text |Cite

Basket, Umbrella, and Platform Trials: The Potential for Master Protocol–Based Trials in Inflammatory Bowel Disease

Sailish Honap,

Bruce E. Sands,

Vipul Jairath

et al.

Help me understand this report

Search citation statements

Order By: Relevance

Paper Sections

Select...

Citation Types

Supporting

Mentioning

Contrasting

Year Published

2024

Publication Types

Select...

Article2

Relationship

Self Cite0

Independent2

Authors

Journals

Cited by 2 publications

References 16 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

The Future of Clinical Trials in Inflammatory Bowel Disease

Ma,

Solitano,

Danese

et al. 2024

Clinical Gastroenterology and Hepatology

View full text Add to dashboard Cite

The Future of Clinical Trials in Inflammatory Bowel Disease

Ma,

Solitano,

Danese

et al. 2024

Clinical Gastroenterology and Hepatology

View full text Add to dashboard Cite

Acute severe ulcerative colitis trials: the past, the present and the future

Honap,

Jairath,

Sands

et al. 2024

Gut

View full text Add to dashboard Cite

Acute severe ulcerative colitis (ASUC), characterised by bloody diarrhoea and systemic inflammation, is associated with a significant risk of colectomy and a small risk of mortality. The landmark trial of cortisone in 1955 was pivotal for two reasons: first, for establishing the efficacy of a drug that remains a first-line therapy today and, second, for producing the first set of disease severity criteria and clinical trial endpoints that shaped the subsequent ASUC trial landscape. Trials in the 1990s and at the turn of the millennium established the efficacy of infliximab and ciclosporin, but since then, there has been little progress in drug development for this high-risk population. This systematic review evaluates all interventional randomised controlled trials (RCTs) conducted in patients hospitalised with severe UC. It provides an overview of the efficacy of treatments from past to present and assesses the evolution of trial characteristics with respect to study populations, eligibility criteria and study designs over time. This review details ongoing RCTs in this field and provides a perspective on the challenges for future clinical trial programmes and how these can be overcome to help deliver novel ASUC therapies.

show abstract

scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.

Contact Info

customersupport@researchsolutions.com

10624 S. Eastern Ave., Ste. A-614

Henderson, NV 89052, USA

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Blog Terms and Conditions API Terms Privacy Policy Contact Cookie Preferences Do Not Sell or Share My Personal Information

Made with 💙 for researchers

Part of the Research Solutions Family.

Basket, Umbrella, and Platform Trials: The Potential for Master Protocol–Based Trials in Inflammatory Bowel Disease

Cited by 2 publications

References 16 publications

The Future of Clinical Trials in Inflammatory Bowel Disease

The Future of Clinical Trials in Inflammatory Bowel Disease

Acute severe ulcerative colitis trials: the past, the present and the future

Contact Info

Product

Resources

About