By Craig Morgan, Head of Marketing, Study Startup, Oracle Health Sciences
Many facets of a clinical trial are unpredictable. Patient enrollment, a critical and often troublesome step, can vary widely within regions, countries and sites, as well as, across therapeutic areas. This unpredictability increases the complexity of clinical trial planning.
Key assumptions are made at the outset of setting up a clinical trial surrounding country and site selection. What if those assumptions shift? Do you know with a certain level of confidence how changes in those assumptions will impact the execution of the study?
This is why scenario planning is so valuable, and critical to helping to manage the variability in clinical trial setup decisions. Scenario planning attempts to eliminate the two most common errors made in any strategic analysis – overprediction and underprediction. Scenario planning puts the power back into the hands of clinical managers by providing them with an opportunity to explore possible outcomes based on a specific combination of events. In essence, it enables them to find the best strategy while balancing risks, resource allocations, and costs, as well as, giving them the insights needed to discuss with internal stakeholders the impact assessment of various plausible scenarios – based on real-time machine learning analysis of anonymized study data.