Trial Performance Metrics in Pivotal Cancer Trials

This is the sixth in a series of blog posts VOI Consulting will publish based on high-level examination of the company’s new insiteinvestigator™ database. It addresses time from pivotal trial initiation to approval, accrual rates, and trial placement patterns for cancer drugs gaining approval during the 2005 to 2011 period.

In addition to understanding key design characteristics, planners also need to know how their trials are likely to perform in the implementation stage. Towards this end, we now examine several key findings from the insiteinvestigator™ database regarding time from pivotal trial initiation to approval, accrual rates, and trial placement patterns.

Development Time

Figure 1 shows the median time required from pivotal trial initiation (defined here as the date of first patient enrollment) to FDA approval by cancer type. (Several cancers are excluded because of limited data). For the cancers shown, the overall median time is approximately 63 months or a little over five years. However, this ranges considerably from a low of 36 months for kidney cancer to a high of more than 100 months in skin cancer trials. Our analysis suggests that these variations are driven by a combination of several factors including the size of the available population, the number of competitive trials taking place at the same time, and how the existing standard-of-care is viewed.

Figure 1 - Median Months from Trial Initiation to Approval

Insiteinvestigator is VOI’s proprietary database containing detailed information on design, endpoints, populations, size, placement, timelines, efficacy outcomes, and safety results for every pivotal trial supporting a cancer drug approved by the U.S. FDA from 2005 through 2011.


Donald Clark
Donald Clark

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