Accrual Rates in Pivotal Cancer Trials 2005 - 2011

This is the seventh in a series of blog posts VOI Consulting will publish based on high-level examination of the company’s new insiteinvestigator™ database. It addresses pivotal trial Accrual Rates for cancer drugs gaining approval during the 2005 to 2011 period.

Accrual Rates

Several of the factors that slow development times are out of the planner’s control. Subject to constraints on the budget and site availability, however, it is generally possible to speed the process by increasing the number of locations hosting the trial. The information in Figure 1 is of interest for this reason as it shows the median accrual rate for various types of cancer. (As with the time to approval data, some cancer types are not shown.) Note that accrual rate is defined as the number of patients recruited per site per month and the number of total months is based on the period from first patient enrolled to last patient enrolled.

The median accrual rate for the included conditions is 0.23 patients per site per month. Using this information, a hypothetical trial with a recruitment goal of 1,000 patients could expect to achieve full enrollment in 43.5 months with 100 sites and 34.8 months with 125 sites. Of course, there is no such thing as a “median cancer” and, as we have seen with the time to approval data, recruitment rates vary considerably between conditions. Unsurprisingly, those with the fastest times to approval also tend to have the highest accrual rates.

Figure 1 - Median Accrual Rates in Cancer Pivotal Trials 2005-2011 (Patients per Site per Month)

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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