Strategic design of a Phase 3 clinical trial to maximize the likelihood of treatment approval

Maximizing the likelihood of becoming a standard-of-care therapy.

The brief

Our client wished to inform the Phase 3 trial design of a potential new oncology asset and required a comprehensive understanding of the evolving treatment landscape in order to identify their most likely competitors and clinical comparators.

The challenge

Our client had limited knowledge of the specific oncology indication and required a more comprehensive understanding in order to design an optimal Phase 3 trial that maximized their chance of regulatory approval and HTA recommendation. They required a systematic appraisal of the current standard of care as well as strategic recommendations on endpoint and outcome focuses for their trial design.  

The solution

We delivered a comprehensive solution to our client encompassing a robust assessment of the current landscape, a review of the evolving competitor landscape, and strategic recommendations on clinical trial design.

  • Through a thorough examination of the prevailing clinical guidelines we were able to define the standard of care and potential treatment comparators.
  • Extending our efforts, we reviewed unmet needs as well as drivers of treatment approval. This analysis enabled us to propose specific clinical trial endpoints and outcomes that our client should target to secure approval of their potential asset.
  • We also performed a review of the competitor landscape in which we highlighted the newer additions to the treatment arsenal, ensuring support of our client’s strategy beyond the Phase 3 trial.

Value to the client

We provided our client with a series of strategic recommendations to inform the design of their Phase 3 trial, ultimately arming them with the expertise needed to target the clinical trial outcomes  most likely to maximize their likelihood of becoming a new standard of care.  

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