Development Of Successful Phase 2 Analgesia Protocols

By David Shoemaker, Ph.D. , Jack Modell, Ph.D., and Ben Vaughn

Once a product has demonstrated an acceptable safety profile in Phase 1 studies, it is time to demonstrate proof of concept in initial Phase 2 studies. Phase 2 is a critical make-or-break phase of product development. Preparation of successful Phase 2 protocols requires the development team to leverage their total understanding of the product development process from preclinical to marketing approval. But more importantly, and particularly for analgesia products, successful protocol development also depends on the team’s application of keen scientific and regulatory acumen within the targeted therapeutic area. Unfortunately, companies all too often jump to implement inadequately designed proof-of-concept studies with hopes for a “quick win” to gain support for future funding or development, or sometimes simply for lack of appreciation of critical success factors for early-phase clinical studies. This rush causes many potentially successful products to be declared ineffective or unsafe and left for dead in the graveyard commonly known as Phase 2. In many cases, partnering with a CRO with demonstrated success in protocol development consulting and a track record of delivering comprehensive clinical regulatory strategies leveraging an interdisciplinary approach can help as you navigate this crucial, yet precarious stage.