COUNTY OF SAN MATEO

Inter-Departmental Correspondence

San Mateo Medical Center

DATE:

April 23, 2004

BOARD MEETING DATE:

May 11, 2004

TO:

Honorable Board of Supervisors

FROM:

Nancy J. Steiger, Chief Executive Officer, San Mateo Medical Center

SUBJECT:

Acceptance of a Grant Award from the Roche Pharmaceuticals

Recommendation

1.

Adopt a resolution accepting a grant from Roche Pharmaceuticals in the amount of $64,170 and

2.

Approve an Appropriation Transfer Request (ATR) to accept unanticipated revenue ($12,834) for FY2003-04 and appropriate new revenue to Contracted Medical Groups ($5,000), Salaries and Benefits ($5,000) and Other Clinical Expense ($2,834)

Background

The Clinical Trials and Research Unit of the San Mateo Medical Center was established by the Health Services Agency in 2000 in order to provide a mechanism and infrastructure for the conduct of clinical treatment trials and medical or psychosocial research projects for the benefit of the residents of San Mateo County. A preliminary assessment by the Unit staff identified HCV associated cirrhosis as a problem affecting many of the County's patients with HIV, for which there was not a clinically proven method of screening in this population.

Discussion

The Clinical Trials and Research Unit submitted a proposal to conduct a study regarding the efficacy and safety of Pegasys plus ribavirin in patients with Chronic Hepatitis C. On March 17, 2004, Roche Pharmaceuticals notified the County that the proposal had been favorably received and the award granted. The County will receive $64,170.00 for fiscal years 2003-2005 over a two-year period. The term of the agreement to conduct the study is February 19, 2004 through July 12, 2005.

The primary purpose of this study is to study the efficacy and safety study of Pegasys plus ribavirin in patients with Chronic Hepatitis C.

Outcome Objectives

The following outcome objectives related to this project will be measured in 2003-2005 using an Evaluation Work Plan included in the grant proposal:

Outcome Measures

(at end of second year)

2003-2005

Objectives

To compare 10 on clinical with Pegasys plus rabvirin.

100%

To study what proportion of patients have sustained virologic response at 72 weeks after treatment.

100%

Vision Alignment

This agreement keeps the County's commitment of responsive, effective and collaborative government, and goal number 21, County employees understand, support and integrate the County vision and goals into their delivery of services. This agreement contributes to this commitment and goal by participating in a study to access the safety and efficacy of Pegasys plus ribavirin in patients with chronic Hepatitis C.

Fiscal Impact

This total amount of the award for the first year is $64,170. An initial start-up amount of $12,834.00 will be paid to the County in fiscal year 2003-2004. The anticipated additional funding of $51,336 will be included in the Recommended Budget for FY 2004-2005, pending patient enrollments. Administrative oversight, technical assistance, and project monitoring will be provided by existing Clinical Trials and Research staff. There is no net county cost associated with this project.