Atopic dermatitis Phase II benchmarking outlook

GlobalData Healthcare 4th October 2019 (Last Updated October 4th, 2019 12:35)

Atopic dermatitis is a red, itchy rash normally located on the cheeks, arms, and legs. It is common in children but can appear at any age, and tends to flare periodically.

Atopic dermatitis Phase II benchmarking outlook

Atopic dermatitis (AD) currently has no cure and is the most common type of eczema. 

AD is a red, itchy rash normally located on the cheeks, arms, and legs. It is common in children but can appear at any age, and tends to flare periodically.

A drug developer for this indication in Phase II should currently expect a 93.85% likelihood of completion and a 1.61% chance of suspension for these trials. The projected median timelines include 8.1 months for the enrolment period and 9.23 months for total trial duration. Enrolment goals suggest an enrolment rate of 1.62 subjects/sites/month, four sites, and 64 subjects based on previously completed trials in this indication. 

It is also important to examine why trials have failed and to learn from these mistakes. The biggest reason for trial termination is low accrual rate (42.9%), followed by lack of efficacy (28.6%) and adverse events (28.6%), as shown in Figure 1. 

This highlights the importance of selecting a suitable country or countries where developers can expect to find an available patient population to run an AD Phase II trial, as well as a study region that is not saturated from other planned or ongoing trials in this indication. The selection of sites and investigators with experience and availability to run these trials will also help developers avoid a low accrual rate and subsequent higher cost of development. 

GlobalData’s Feasibility Planner uses different algorithms to recommend the best geographies, investigators, and sites to help developers make informed decisions when planning these studies.