Knowledge is half the battle. Do the patients even exist to fulfill your protocol criteria?

Traditional protocol feasibility relies on opinions and is not based on actual patient metrics. Trialytics allows you to test each inclusion and exclusion criterion against the single largest database of patients available to determine potential roadblocks to your study’s enrollment success.

The essential elements of Trialytics’ approach are:

• Identify database requirements for each key inclusion and exclusion criterion
• Establish a preliminary ranking for all of the inclusion and exclusion criteria, ranking them on their potential degree of impact on the pool of eligible patients
• Perform database queries
• Identify gaps that will require focused reviews of medical literature or that will benefit from validation using published literature
• Demonstrate the impact that each testable inclusion and exclusion criterion will have on the eligible enrollee population and simulate how the eligible population would change with incremental changes in the specifications, wherever possible
• Gain insight into the feasibility of the protocol as written and determine how the criteria can be refined to optimize enrollment, while ensuring that drug safety may be adequately assessed and that the enrolled population can reasonably be expected to reach target study endpoints

Relying on opinions is costly and time-consuming. On average, each Phase III protocol undergoes three to five amendments, with each amendment taking 3 to 6 months to implement and costing an estimated $250,000. Your time, resources, and money are better spent elsewhere!

The Trialytics team is happy to discuss your protocol feasibility with you at any time. Please call 610-238-5289 or e-mail trialytics@sdihealth.com for more information.