RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--The number of patients enrolled in a clinical trial is a key determinant in the trial’s total cost. Clinical executives look to per-patient costs to compare clinical studies of differing sizes.
Cutting Edge Information’s study “Oncology Clinical Trials: Drug Development Resources and Case Studies” found that per-patient cost metrics also include other fixed costs related to clinical trial operations, such as capital equipment, investigator meetings and an ethics review. Each of these additional costs is independent of patient enrollment. Therefore, two trials requiring the same exact medical procedures may have differing per-patient trial costs if one incurred higher fixed costs than the other.
Total cost for Phase 3 oncology trials fell within a narrower range ($110 million) compared to both Phase 1 ($297 million) and Phase 2 trials ($270 million). However, Phase 3 per-patient costs are significantly higher than in other development phases. The study found that higher patient enrollment for Phase 3 trials results in fewer per-patient cost outliers compared to earlier phases. Trials with low patient enrollment are unable to defray the costs of high-priced expenditures, such as assay development or specialized transportation for perishable drugs, across hundreds of patients as in Phase 3.
“That is not to say that Phase 3 oncology trials never experience high per-patient costs,” said Ryan McGuire, research team leader at Cutting Edge Information. “The average Phase 3 per-patient cost of $74,800 is higher than the Phase 1 and Phase 2 trials examined in this study. Furthermore, three Phase 3 trials surpassed $100,000 in per-patient costs — more than almost every Phase 1 or Phase 2 trial that we studied.”
“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 Phase 3 clinical development resources. 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 per-patient cost 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.
For more information about clinical research associate benchmarks, contact Cassie Demeter at 919-403-6583.