Patient Enrollment is a Critical Cost Driver in Phase 1 Clinical Trials
News Jun 19, 2013
Both the number of patients and trial duration heavily impact a Phase 1 oncology trial’s total cost. The underlying force driving most costs is patient enrollment. As the time to reach full enrollment increases, the trial lasts longer and the cost of maintaining and staffing clinical sites rises.
Cutting Edge Information’s study “Oncology Clinical Trials: Drug Development Resources and Case Studies” discovered that for Phase 1 clinical trials, patient enrollment ranges from 25 to 97 patients with an average of 47.8 patients. As the patient pool increases, trial costs rise as well. Trials enrolling 40 or fewer patients report an average cost of $2.7 million. Trials enrolling more than 40 patients report an average cost of $7.6 million.
The Phase 1 oncology trials included in the study reported very little variability in the average planned and actual enrollments. The planned and actual enrollment numbers differ on average by fewer than two patients. Additionally, Phase 1 is the only phase to report small increases from planned to actual patient enrollment.
“Overall, the trend shows an increase in trial costs with increasing patient enrollment,” said Ryan McGuire research team leader at Cutting Edge Information. “The correlation coefficient between number of patients and trial cost is relatively strong. The expected patient enrollment helps a clinical program leader gauge the total cost of the trial. Higher enrollment generally requires more time, staff and site.”
“Oncology Clinical Trials: Drug Development Resources and Case Studies” features detailed oncology clinical development data including specific methods for best allocating resources in Phase 3. The research also highlights up-to-date metrics illustrating oncology clinical trial costs, one of the largest areas of study for the pharmaceutical industry. Drug companies that manufacture oncology medicines can use this report to:
• Explore areas of higher activity for different types of cancer drug development.
• Determine the cost per patient and other critical cost drivers for different types of oncology clinical trials.
• Compare predicted and actual patient enrollment metrics of 30 oncology clinical trials from Phase 1 to Phase 3.