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®SCS Capabilities — Clinical Development Program Design
In the competitive pharmaceutical and biotech landscape, the market success of any new product depends on how well a company executes a clinical development program. Success depends on integrating scientific, clinical, regulatory, and marketing approaches to the development and commercialization of therapies that go beyond the optimization of a single clinical trial.
Pharsight® partners with your development team to design a program that fully explores possible treatment regimens and clinical trial sequences for the highest value clinical development strategy. Clinical development program design addresses the types of trials as well as the sequence of trials that provide the basis for making informed “go/no-go” decisions.
Pharsight's integrated approach supports critical analysis of each new product, monitoring of development time and resource utilization, and effective allocation of R&D resources.
Clinical development program design offers several important benefits:
- Eliminate unnecessary or redundant clinical trials used for internal decision-making
- Identify and address critical path issues that could delay development timelines
- Ensure that clinical programs focus quickly and unambiguously on key attributes of the compound
Objective |
Approach/Methods |
Design a clinical development program that increases confidence for decision-making. |
Build models to provide a transparent basis for decision-making for development projects and programs. Define and track critical success factors and their uncertainty. |
Incorporate industry knowledge into your development plans. |
Evaluate the scientific merit of published literature on pharmacological activity and potential clinical efficacy and safety. Interview thought leaders to support development strategy. Incorporate this knowledge into models of disease and competitive drug efficacy and safety. |
Optimize the compound’s regulatory strategy. |
Assess prior product precedents; review relevant Advisory Committee opinions, current FDA policy and unique requirements in appropriate review Divisions. Take advantage of new trial design and analysis options discussed in the FDA Critical Path White Paper. |
Optimize the compound’s commercial value. |
Work with your company’s experts and appropriate thought leaders to leverage data on physician prescribing behavior (e.g., conjoint analysis); develop a clinical utility index (CUI). |
Ensure competitive success. |
Estimate utility of the product relative to competitors given the current state of knowledge, based on the integrated models, conjoint results or Clinical Utility Index. |
Determine a treatment regimen that optimizes the product profile. |
Model and simulate a set of alternative development programs. |