Strategic design of Phase III 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 III trial design of a potential new oncology asset and required a comprehensive understanding of the evolving treatment landscape, in order to determine their most likely key competitors and clinical comparators, to help shape an optimal trial strategy should they proceed with the acquisition.  

The challenge

Our client had limited prior knowledge of the specific oncology indication and required a more comprehensive understanding in order to design an optimal Phase III 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, the evolving competitor landscape, and strategic recommendations on a trial design poised for successful treatment approval.

  • Through a thorough examination of the prevailing clinical guidelines in the treatment domain, we were able to ascertain essential standard-of-care therapies and potential comparator treatments for our client.
  • Extending our efforts, we reviewed unmet needs and the drivers for approval within the latest expansions of the therapy field. This strategic analysis enabled us to propose specific clinical trial endpoints and outcomes that our client should target to secure treatment approval.
  • These findings were completed with a review of the competitor landscape, where we highlighted new additions to the treatment space, ensuring we supported our client’s strategy design beyond just the phase III trial.  

Value to the client

We provided our client with a series of strategic recommendations to inform the design of their Phase III trial, ultimately arming them with the expertise to target the clinical trial outcomes that maximize their likelihood of becoming a standard-of-care therapy.  

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