RESEARCH TRIANGLE PARK, N.C.--()--A useful metric in planning for different oncology clinical trial phases is the ratio of patients to investigator sites. The profiled trials in Cutting Edge Information’s latest study show a strong correlation between number of patients and number of sites.
“These clinical tests require patients with a very specific disease state, slowing patient recruitment.”
The study, “Oncology Clinical Trials: Drug Development Resources and Case Studies,” uncovered the average number of patients per site of reported oncology trials. Phase 1 trials span the widest range: 5.3 to 35.3 patients per site. The average ratio reported for Phase 1 trials is 12.9 patients per trial site. Phase 2 and Phase 3 trials average 3.4 and 5.1 patients per site, respectively.
“Phase 2 and Phase 3 trials have much smaller patient groups at each investigator site,” said Ryan McGuire, senior research analyst at Cutting Edge Information. “These clinical tests require patients with a very specific disease state, slowing patient recruitment.” Because of this requirement, trial managers depend on more sites. Although average overall enrollment is much greater for later-phase trials, enrollment is spread over many more sites.
Overall, trial managers can plan for higher patient enrollment per Phase 1 trial site. Phase 1 trial protocols generally require fewer patients, simplifying the patient recruitment process. The combination of patients and healthy volunteers makes recruitment easier yet. Meanwhile, Phase 2 and Phase 3 trials tend to have more sites while serving fewer patients at each site. These metrics are useful to trial managers when deciding how many sites a trial will need to reach the target patient enrollment level.
“Oncology Clinical Trials: Drug Development Resources and Case Studies” (http://www.cuttingedgeinfo.com/research/clinical-development/oncology-clinical-trials/) features detailed data on clinical development for oncology treatment including specific methods for allocating the correct resources in Phase 3. The research also highlights up-to-date metrics illustrating clinical costs for oncology trials, 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.
- Get a robust picture of each phase’s challenges and costs.
- Determine the cost per patient and other critical cost drivers for different types of oncology clinical trials.
For more information about oncology clinical development benchmarks, contact Cassie Demeter at 919-403-6583.