Early Phase Success Is No Guarantee Of Final Approval
Success in an early phase trial is just the first step along the path to market approval but there is no guarantee. The most frequently identified reasons for trial failure are study design, site selection, inadequate recruitment, patient burden or safety issues, and poor trial execution. To combat the risk of a failed trial, a proactive approach and meticulous execution are crucial to laying a firm groundwork for subsequent phases. Protocol execution starts with recruitment and by enrolling the right amount of patients or healthy volunteers to make your dataset viable enables advancement in later phase trials.
The Shifting Landscape Of Early Phase Trials
The field of pharmaceutical research is in a perpetual state of flux, with the continuous emergence of new scientific knowledge and the constant refinement of regulatory policy. Sponsors need to be alert to new regulatory developments, while at the same time remaining poised for new opportunities as they arise. You have a lot at stake in your early phase trial, and the perpetual movement of science and regulation adds extra levels of risk. But, by applying a strategic approach to innovation, you can discern and leverage the necessary and beneficial shifts in early phase trial practice to drive your success.
Trial execution can make or break your early phase program. If lab services and study participants are ignored, the outcome of your study is questionable at best. Finding the right partner who offers only the highest standards and levels of expertise is your best bet for a successful program.