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PP06-49: How to Prioritize Indications in Early Clinical Development Using a Decision Framework to Assess the Overall Attractiveness





Poster Presenter

      Elke Roschmann

      • Senior Director
      • IQVIA R&D Solutions Gmbh
        Germany

Objectives

Demonstrate a rigorous process by which indications can be prioritized to make the best use of resources in the early clinical development process

Method

the case studies used to illustrate our indication prioritization approach were conducted in 2019. They involved the use of medical literature, medical claims data, internal trial time and cost data, epidemiology data, competitive pipeline data, and a clinical development scenario simulation tool.

Results

The approach that our team has developed involves tackling the problem of indication prioritization from three different angles: • Scientific Rationale • Market attractiveness • Feasibility of the opportunity The scientific rationale involves looking at disease linkage, mechanistic plausibility, pre-clinical and clinical evidence. In this phase assesses the molecular properties of the compound by a team of SMEs. Market attractiveness includes defining the unmet need, addressable patient population, current SOC, epidemiology of the disease to inform the market prospect. This stage leverages claims, EMR and clinical trial landscape data. Feasibility: how practical is it to conduct trials in these indications? Is enrollment easy or difficult? Is the cost per study subject exorbitant? What is the regulatory pathway? What are the realistic time and costs for such trials? This part of the project relies heavily on benchmark time and cost data from prior similar trials. The final phase consists in building a prioritization matrix where different weights are given to each of the research elements explained above to come with a ranking to compare the relative attractiveness of indications. The final phase consists in building an indication prioritization matrix where different weights are given to each of the research elements explained above to come with a prioritization ranking to compare the relative attractiveness of indications against each other.

Conclusion

In our poster, we will present blinded case studies where we successfully applied this methodology to prioritize indications in therapy areas such as oncology and neuropathic pain.