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December 23, 2019

Benchmarking Phase II industry-sponsored colorectal cancer trials

Colorectal cancer is the second most common cause of cancer deaths in men and women combined in the US.

By GlobalData Healthcare

Colorectal cancer begins in the colon or rectum; it is also named colon cancer or rectal cancer, depending on where it originates. According to the American Cancer Society, about 101,420 people in the US will be diagnosed with colon cancer and 44,180 with rectal cancer in 2019.

Colorectal cancer is the second most common cause of cancer deaths in men and women combined in the US. A drug developer for this indication in Phase II should currently expect an 81.88% likelihood of completion and a 0.89% chance of suspension for these trials. Projected median timelines include 19.77 months for the enrollment period and 32.10 months for total trial duration. Enrollment goals suggest a median enrollment rate of 0.39 subjects per site per month, seven sites, and 58 subjects, based on previously completed trials in this indication.

It is also important to examine why trials have failed and to learn from these mistakes. The biggest reasons for trial termination are low accrual rate (41%), followed by business/strategic decisions (24%) and adverse events (14%), as shown in Figure 1.

Such a low accrual rate highlights the importance of selecting a suitable country or countries where developers can expect to find an available patient population to run a colorectal cancer Phase II trial, as well as a study region that is not saturated from other planned or ongoing trials in this indication. The selection of sites and investigators with experience and availability to run these trials will also help developers avoid a low accrual rate and subsequent higher cost of development. GlobalData’s Feasibility Planner uses different algorithms to recommend the best geographies, investigators, and sites to help developers make informed decisions when planning these studies.

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