New study evaluates disparity between planned versus actual patient enrollment in oncology trials

Dec 12 2013

Expected and actual patient enrollment differs by an average 7.1% among the Phase 3 oncology trials examined in a recent Cutting Edge Information study.

The study, "Oncology Clinical Trials: Drug Development Resources and Case Studies," evaluated the disparity between planned versus actual enrollment. The difference of 7.1% highlights trial managers' difficulty reaching their initial patient recruitment targets. In fact, only 29% of the oncology trials examined in the study reached their patient recruitment targets.

"Oncology trials typically set high enrollment goals because the nature of the disease often increases patient drop-out rates, said Ryan McGuire, research team leader at Cutting Edge Information. "Unfortunately, many patients fail to live through the trial's full duration. Or in certain instances, they are forced to withdraw because of painful side effects."

The patient dropout trend puts oncology trial managers in a difficult position when attempting to forecast total enrollment needed to retain an adequate number of patients through trial completion. Additionally, only one trial examined in the study exceeded initial enrollment goals. On the other hand, Phase 3 studies did sometimes set ambitious enrollment targets — two-thirds of trials planned for or actually recruited 500 or more patients.

Furthermore, the research discovered a strong correlation between patient enrollment and total trial cost. Specifically, trials with patient enrollment goals under 550 patients cost an average of $29.9 million, while trials with more than 550 patients experienced an average total trial cost of $56.5 million.

"Oncology Clinical Trials: Drug Development Resources and Case Studies" (http://www.cuttingedgeinfo.com/research/clinical-development/oncology-clinical-trials/) details oncology clinical development data, including specific best practices and strategies for allocating clinical development resources. The study also includes benchmarks on oncology trial costs per phase. Drug companies that manufacture oncology treatments can use this report to:

• Explore areas of higher activity for different types of cancer drug development.
• Determine the per-patient cost and other critical cost drivers for oncology clinical trials in different disease states.
• Compare the predicted and actual patient enrollment metrics of specific oncology clinical trials from Phase 1 to Phase 3.

Source: Cutting Edge Information