Long Development Times Linked to Low Patient Accrual Rates for Cancer Trials

A recent study from Oregon Health and Science University (OHSU) indicates that 40 percent of all cancer trials do not achieve the minimum accrual goals necessary to achieve a statistically significant conclusion. Additionally, it was found that the longer the preparation time required to develop the clinical trial, the harder it was to accrue enough participants to complete the study.

The findings stem from an evaluation of more than 550 therapeutic, non-pediatric phase I, II and III clinical trials that took place from 2000 to 2007. All trials were sponsored by the National Cancer Institute’s Cancer Therapy Evaluation Program (CTEP). For the study, trial development time was defined as the time from initial CTEP submission to the time enrollment of patients began.

Among all trials reviewed, the median development time was 15 months. Those with a relatively fast development time (9 to 12 months) achieved minimum accrual requirements 77 percent of the time. In contrast, studies with lengthy development times (more than 27 months) achieved minimum accrual requirements just 22 percent of the time.

The team at OHSU, headed by Dr. Steven K. Cheng, is now looking at how current efforts to shorten clinical development times may improve accrual rates.

Finding patients to participate in cancer trials has become a growing concern among the cancer community. Though 1.5 million people are diagnosed with cancer each year, only three to five percent ever enroll in a clinical trial.