FDAnews Drug Daily Bulletin

Clinical Investigators Addressing 'Hidden Costs' With Help From Sponsors

June 16, 2005

Clinical investigators are increasingly turning to industry sponsors to help them cover "hidden" trial costs - such as prestudy services - that are starting to eat away at research institutions' operating budgets.

Many research sites are having to carry out preassessment feasibility analyses that cost upwards of $10,000 before the trial's first patient is even seen, according to RxTrials, a research organization that conducts clinical trials services in the Greater Washington and Baltimore region. RxTrials recently performed a cost analysis and estimated that investigative sites in the Washington/Baltimore area pay an average of $9,055 in prestudy assessment costs for each trial they conduct.

Prestudy funds are typically used to perform analyses and price assessments to determine if the site is capable of conducting the research required by the sponsor. For example, if the trial requires patients to receive an X-ray, the site needs to contact a radiology office to determine the costs. Sites also need to educate their investigators and coordinators about the research, conduct protocol reviews and send detailed reports to their institutional review boards.

In the past, many sponsors have balked at providing financial commitments for preclinical services, but that appears to be changing, said Michael Jay, contract and budget manager at RxTrials, who noted that sponsors are becoming more willing to include prestudy costs into contract negotiations.