PAREXEL - Dr Sy Pretorius Speaks on the Building Blocks of Protocol Optimization
Every protocol has certain standard elements or building blocks as I'd like to call them. For example, every study has a design, it has primary and perhaps some secondary or exploratory objectives, it has a sample size, inclusion and exclusion criteria, study procedures etc. Each of these building blocks or key protocol elements can be viewed or evaluated through a variety of different lenses – for example, you could look at each of these building blocks through a scientific lens or a regulatory lens or are a commercial lens or an ethical lens and so forth. By carefully evaluating and challenging each of these building blocks via the different lenses, we compile different scenarios or options for running the same study. Once these different scenarios are compiled, they are mapped out to assess their impact on project time and they are also costed out to assess the impact on project budget. The final deliverable maps these scenarios along the cost and time axes. This is then shared and discussed in detail with our clients who make the final decision in terms of the scenario that they would like to write into the protocol. Typically, and for the majority of the scenarios there are various trade-off decisions that our clients need to make. Having quantified the impact of the various options of scenarios on time and budget assists our clients in making the best decisions based on the information they have.