PRODUCTS

StudyOptimizer – Plan

A good enrollment plan is critical to completing the patient enrollment process on time. In developing enrollment plans, study managers often miss valuable insights and fail to spot potential problems because they lack the tools to forecast effectively and to quickly identify clinical trial enrollment trends. Home-grown models built with Microsoft Excel® can plug in assumptions, but can’t visualize and predict problems. Without the ability to run simulations and plan scenarios, study managers are unable to validate their enrollment plans.

Model and Compare Your Planning Assumptions

StudyOptimizer allows Study Managers to leverage the information that resides in their organizations by looking at historical enrollment data and creating plans that reflect these metrics. For larger trials, the enrollment planning process can be broken down and delegated to site or country managers, so that they can build in the unique metrics and enrollment behaviors for their specific environments. Multiple plans can be created and tested against each other to identify the approach that optimizes the overall cost and delivery timing of the clinical trial.

StudyOptimizer Planning Process

Organizations may differ in their approaches to clinical trial planning, but most studies can begin only after a Clinical Trial Protocol has been drafted. Users often start creating enrollment plans within StudyOptimizer between the time when the concept protocol has been drafted and the final protocol is complete. Using StudyOptimizer in this early phase helps you determine the optimal number of countries and sites that should participate in the study.

Here are the key steps in the planning process, using StudyOptimizer

  1. Define global study targets
    • Number of subjects to randomize
    • First Site Initiated milestone (FSI)
    • Last Subject Randomized milestone (LSR)
  2. Add countries that will participate in the study
  3. Define individual enrollment plans for each country
    • Including country-specific targets for number of subjects, FSI, and LSR
    • Including country-specific performance assumptions such as expected screen failure rates, site initiation schedule, etc.
  4. Evaluate each country plan to determine whether it is forecast to meet its targets
  5. Evaluate the global study plan to determine if it is forecast to meet its targets
    • Individual country plans are “rolled up” into an aggregated forecast
  6. Refine and revise plans until they are forecast to meet study targets
  7. Approve the global study plan that most closely matches your study’s requirements and timeline.

 

Related Terms:
predictive analytics, clinical trial tools, enrollment modeling

Plan

Model and Compare Your Planning Assumptions.

 

 

Planning Capabilities

  • Collaborate in plan creation
  • Test best-case, worst-case plans before approval
  • Establish a baseline for study
  • Maintain a record of all plans developed
  • Use consistent assumptions across the organization