Uniform Clinical Trials Protocol

Year: 
2013
PI Name: 
James A. Solomon, MD, PhD
Type:
Other
Status: 
Complete

Summary

The purpose of this project is to develop an initial core Uniform Clinical Trials Protocol with defined clinical endpoints, statistical analyses, safety procedures and vendor charters intended to meet FDA requirements.

Abstract

This Core Uniform Protocol is the first step in a precedent setting process by a patient advocacy group with the support in principle by the FDA to facilitate and drive clinical research toward finding safe and efficacious treatments for alopecia areata. The purpose is two-fold:  Firstly, to develop a plug-and-play template to entice biopharmaceutical companies to test medications on alopecia areata; Secondly, to establish a framework wherein data from clinical trials for the treatment of alopecia areata can be easily compared through consistency of inclusions/exclusions, safety, and outcome assessment measures. The plan is to develop a core protocol which includes primary inclusion and exclusion criteria, safety measures, and outcome assessment tools. This core uniform protocol is for pharmaceutical investigative products which have already confirmed Phase I safety, and preliminary small proof of concept. Thus, it is conceived for a Phase II or III trial.

Impact

Companies can simply plug in specific product data enabling studies to move rapidly from concept to completion.

Publication

Solomon JA. Development of Uniform Protocol for Alopecia Areata Clinical Trials. J Investig Dermatol Symp Proc. 2015 Nov;17(2):63-6. doi: 10.1038/jidsymp.2015.45