Meeting the Challenges of Phase 2 Clinical Development

Some investigational products successfully make the transition from phase 2 to phase 3 while most fall by the wayside. Disregarding products that fail because they simply lack efficacy or safety, what makes the difference between phase 2 success for a relative few products and failure for most?

In our view, the key to maximizing chances of success in phase 2 is individualizing everything about your development program to address the unique requirements of the investigational product, target indication and target population. Cookie-cutter methods do not apply. It is important to learn from past projects, but what phase 2 development requires is intense focus on everything that makes the current investigational product different. The project team must account for such differences throughout program planning, trial design and trial conduct. A new Health Decisions white paper, Perfecting Phase 2: 10 Essential Steps for Individualizing Clinical Development for the Unique Requirements of Each Investigational Product, summarizes some of the aspects of development that require individualization in phase 2.

To be sure, the high rate of phase 2 failures shows that clinical development is inherently difficult. However, it also raises questions about whether we need to rethink the way our conventional development approach charts a course from first-in-human testing to marketing approval. Is the standard progression from phase 2a to phase 2b and, sometimes, on to phase 3 serving the industry and the public well? Could there be a better way? Look for a post on that topic soon.

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