Dear E,
Phase 2 is a critical make-or-break stage of product development. All too often, companies inadequately prepare their regulatory strategies and protocols for these proof-of-concept studies causing potentially successful products to be declared ineffective or unsafe.
Preparation of Phase 2 protocols requires the clinical development expertise to leverage a complete understanding of the product development process from preclinical to marketing applications. This guide outlines the components you should consider for designing Phase 2 protocols with marketing approval in mind.
While the guide outlines key points to consider for protocol design applied to an analgesia product, the fundamentals of this interdisciplinary approach can be applied within most any therapeutic area.
At Rho, we start with the end in mind. Download our guide to see the keys to designing Phase 2 protocols that will provide meaningful, supportive data to successful marketing applications. This document outlines the following key considerations:
- Objectives, Clinical Endpoints, and Proof of Concept
- Dosage Determination
- Inclusion/Exclusion Criteria
- Statistical Analysis Plan
