Funding academic oncology clinical trials.

Abstract

e16507 Background: Oncology clinical trials departments (CTD) improve patient care by addressing clinical problems through clinical trials. CTDs participate in trials sponsored by industry (e.g. pharmaceutical company) or academic research groups (e.g. co-operative group trial). However, many CTDs operate in a fiscal deficit, relying upon the host centre or hospital for financial support. This study compared the net income trend of academic and industry trials to illuminate how different payment models contribute to the financial burden of CTDs. Methods: We retrospectively examined the lifetime costs for 2 academic and 2 industry oncology clinical trials. Studies were conducted at the CTD within a large academic cancer hospital in Ontario, (approximately 75-100 active trials on-going). For each trial, we analyzed the monthly net income (cash flow minus costs) from accrual start date to end of follow-up, up to 10 years. Data sources included accrual start and end dates from patient charts and estimated costs (e.g. staff time) from departmental financial records. Results: The payment schemes and lifetime trial costs differed markedly for academic vs. industry trials. For academic trials, payments typically occurred upon each patient’s accrual with little or no remuneration for follow-up visits. Once accrual ended, monthly net income quickly became negative. In contrast, payment for the industry trials occurred in stages, beginning at patient accrual and continuing at each visit or milestone. Follow-up duration was also considerably shorter for industry compared to academic trials, meaning deficits due to follow-up costs were minimal. Conclusions: The payment model of academic trials resembles a ponzi scheme: CTDs are using the revenue earned by accruals from an existing academic trial to pay for the follow-up costs of a past trial that is no longer generating revenue. Reforms are needed to prevent a global “bail-out” to save the industry of conducting clinical trials.