A large biotech was developing a new PD-1 immuno-oncology asset in Phase III clinical trials across eight solid tumors made more challenging by an intensely crowded oncology space. As part of its commercialization plan, the client wanted understand how to optimize clinical trial designs in order to achieve successful market access in US, EU5, China and Japan. ADD PRO instrument wanted to understand how best of optimize them


  • We agreed seven analogues in the client and assessed them which helped to highlight challenges and key learnings of clinical/economic evidence generation
  • Assessing competitive advantage by looking at unmet need, reimbursement status of current standards of care and the future treatment landscape to better inform the client in an already crowded and potentially even more competitively oncology space
  • We tracked the most commonly used PRO instruments providing insight on their value and weight in reimbursement decisions
  • Presented it in a workshop format and helped consolidate thoughts across medical and commercial teams in shaping their optimal trial designs


The team got agreement on best trial design for the asset in light of the future competitive environment. It fostered alignment between the medical and commercial teams and realistic assessment of the opportunity in the highly crowded marketplace.

By working with P4A to develop a clear understanding of the environment and requirements for HTA authorities, we are able to confidently move our asset forward into the next phase of development

Health Economics & Outcomes Research Lead