This Solution Provider Archive Webinar is brought to you by DIA in cooperation with Cytel.
International regulators are calling sponsors to increasingly conduct CV outcomes studies. The costs necessitated by the additional trials will be measured in the $100’s of millions of dollars per program. The full impact to be felt by every sponsor, of any size engaged in therapeutic areas where cardio-related events are a concern.
Add Increased Complexity to Increased Costs
Implementation and support complexity levels typically go up across the board, beginning with effectively managing the hurdles of combining data from multiple studies and then supporting the need for thoroughly integrated analysis and reports.
The greatest costs and resource strains will apply to (naturally) the biggest, most important trials - CV outcome trials (CVOT). Assessing necessity, design, and timing of CVOT trials is of critical strategic importance.
With some sponsors the experienced resources exist but they’re already stretched across multiple programs. Other developers don’t have the capabilities, resources and tools in the first place.
Background Info: Relevant FDA Guidance
Diabetes trials in particular heavily employ cardiovascular outcomes studies. Click here for a link to relevant FDA Guidances.
Relevant FDA Guidance: Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes
- Designing non-inferiority trials for CV outcome studies
- Including adaptations: sample size re-estimation, population enrichment, superiority switch
- Event modeling, interim analysis and study end forecasting, interim simulations, predicitive interval plots
- Describe strategies to address pre and post-marketing requirements