KOL Perspectives: Adaptive Trial Designs in IBD

Summary

This KOL Insight briefing focuses on KOLs views of Adaptive trial designs in IBD.

Questions topics -

• Current challenges in IBD clinical trials


• Adaptive Phase II/III trial designs


• Guselkumab’s Phase II/III trial in Crohn’s disease


• Novel clinical trials in IBD

Key Highlights

• Most KOLs highlighted that recruitment is the greatest challenge in IBD clinical trials, both across Crohn’s disease & UC


• Most KOLs flagged Phase II/III trials could accelerate development, but may limit ability to analyze data & adapt trial design


• Most KOLs cited 8-12 weeks as being the minimum duration of a Phase II trial in IBD, with open-label extensions favored by all KOLs.

Scope

• The insight briefing is based on Sociable Pharma’s analysis of primary research with our IBD key opinion leaders (KOLs).

In total, we conducted interviews with 10 KOLs -

• 5 Europe-based & 5 N. America-based


• Interviews performed during July 2018

KOL data is analyzed to produce -

• Charts summarizing KOL opinions


• Chart call-outs of key information & details


• KOL quotes


• Summary of KOL reporting trends


• Insight from Sociable Pharma's analysts

Reasons to Buy

• Combines Qualitative & semi-quantitative insight from key opinion leaders on Adaptive trial designs in IBD


• Includes insight & recommendations from our disease-specific healthcare analysts


• Utilizes independent expert viewpoints to validate the impact of new clinical data & emerging trends on management of IBD


• Provides cost-effective support for your advisory boards, with topics acting as a catalyst for further expert discussion.