NEGOTIATING A BUDGET FOR INDUSTRY-SPONSORED TRIALS. Sponsors commonly underestimate a site’s costs for performing clinical trials. To give Principal Investigators an opportunity to recover all costs, the RSO constructs a careful study budget when it begins work on a new project and reviews it with the PI. When sponsors make an initial budget offer that is insufficient to cover projected costs, the RSO will attempt to negotiate an appropriate budget. Most sponsors recognize that quality performance cannot be expected if reimbursement is insufficient. In 2000, the RSO negotiated final budgets that were 202% higher than the sponsors’ initial offer. In 2001 our negotiated budgets were 162% higher than the initial offer. The RSO can assist faculty and their staff develop fixed price agreements with industry sponsors; contact Debbie Dykhuis, Associate Director of the RSO, at 624-9154 or dykhu001@umn.edu.
 

CLINICAL TRIALS ARE TIME INTENSIVE. The administrative burden of performing a clinical trial is substantial. Using the TASCS system (a computer-based time tracking system), the RSO has been able to quantify the time required to accomplish discreet tasks involved in initiating or performing a clinical trial. For example, on average, obtaining approval from the Cancer Protocol Review Committee requires 3.7 hours of RPM time. Obtaining approval to perform a study in the General Clinical Research Center (GCRC) requires 7.2 hours, whereas completion of the IRB application and writing the consent form (including responding to all IRB questions and stipulations) requires 14.8 hours (range 3 to 34 hours). Developing and negotiating the study budget requires 8.5 hours (see above regarding the increase in contract value resulting from this work), whereas assembling and obtaining signatures on the Proposal Routing Form and related work requires on average 3.5 hours. Processing protocol amendments requires on average 3.4 hours per trial. Once a study is underway, reporting Serious Adverse Events to the IRB requires on average 6.8 additional hours per clinical trial.