RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Protocol design elements, such as subject visit frequency, significantly impacts the budget for Phase I clinical trials, finds Cutting Edge Information data.
The study, “Phase I Clinical Trials: Optimizing Cost-Drivers for Clinical Pharmacology Programs,” revealed an average of 6.8 per-patient visits across all therapeutic areas studied. Trials in endocrinology/metabolic diseases, central nervous system/neurological diseases and gastroenterology all fell close to this average. Several therapeutic areas, including cardiovascular, reported approximately half the average number of visits.
Oncology trials, however, report a far greater average number of visits — 9.3 across the Phase I oncology studies included in the data. Oncology trials typically have more frequent visits; an interviewed pharmaceutical executive reports having anywhere from five to fifteen visits required over three to four weeks for his oncology Phase I study.
For surveyed trials with five to seven patient visits, total costs ranged from $400,000 to $4 million. The cost per patient was higher than for trials with only one to four patient visits. The per-patient average ranged from $16,000 to approximately $80,000.
Trials with the highest numbers of patient visits — eight to fifteen — spanned a wide range of total costs, from a $250,000 trial to one $13 million trial. Oncology trials were responsible for the highest and lowest total trial costs. The cost per patient for these trials with frequent patient visits also varied significantly. Per-patient costs ranged from $11,000 to $309,524.
“Overall, the study shows a positive correlation between the number of patient visits and cost per patient,” said Ryan McGuire, research team leader, Cutting Edge Information. “Higher numbers of patient visits, along with the procedures involved, are major cost-drivers when determining a Phase I trial budget.”
“Phase I Clinical Trials: Optimizing Cost-Drivers for Clinical Pharmacology Programs,” (http://www.cuttingedgeinfo.com/research/clinical-development/phase-i-clinical-trials/) examines the critical cost drivers when budgeting for Phase I trials. It includes detailed cost-per-patient data for 10 different therapeutic areas. Use this report to:
- Manage critical cost-drivers when budgeting for Phase I trials.
- Save time and prevent costly delays with early strategic planning.
- Balance the number and quality of trial sites during site selection to manage patient enrollment and drop-off rates.
For more information about Phase I clinical trials, contact Cassie Demeter at 919-403-6583.