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Case Study # 3: Iterative Protocol Design

Proof-of-Concept data was required in the utility of a molecule in alleviating the toxic effects of a commonly used chemotherapeutic agent. The end-points of this study were clear. However, the measures that could be employed to achieve these end points ranged from the highly subjective to the objective. We therefore proposed a two-stage strategy, the first being an exploratory study, wherein we established the criteria and techniques that we would employ to measure the end-points. The exploratory study eventually segued into a 60 patient trial, the data from which was critical to the company seeking future funding.

In our experience, clients are often constrained in their trial design thinking by western cost and feasibility assumptions. For example, an end-point may best be determined by a complex test such as an fMRI or a CT scan. However, as these techniques are cost-prohibitive in a 100 patient trial, the company has not thought of including these valuable metrics in their early stage Proof-of-Concept studies. In India, most of these high-end techniques cost less than 10% of their U.S. costs – allowing scientists to do more within a limited budget.