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COUNTY OF SAN MATEO
Inter-Departmental Correspondence
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San Mateo Medical Center
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DATE:
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March 7, 2005
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BOARD MEETING DATE:
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March 29, 2005
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SPECIAL NOTICE/HEARING:
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None
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VOTE REQUIRED:
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Four-fifths vote
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TO:
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Honorable Board of Supervisors
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FROM:
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Nancy J. Steiger, Chief Executive Officer, San Mateo Medical Center
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SUBJECT:
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Acceptance of a Grant Award from InterMune, Inc.
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Recommendation
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1. Adopt a resolution accepting a grant from the InterMune, Inc. in the
Amount of $69,780 to study the safety and/or efficacy of Two Dose Levels of Interferon alfacon-1 (Infergen®, CIFN) Plus Ribavirin Administered for 48 Wks vs. No Treatment in Hepatitis C Infected Patients who are non-responders to previous Pegylated Interferon Alfa Plus Ribavirin therapy; and
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2. Approve an Appropriation Transfer Request (ATR) to accept unanticipated revenue ($69,780) for FY2004-05 and appropriate new revenue to Clinical Trials and Research ($69,680).
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Vision Alignment
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Commitment: Ensure basic health and safety for all.
Goal 8: Help vulnerable people – the aged, disabled, mentally ill, at risk youth and others – achieve a better quality of life.
This grant contributes to this commitment and goal by giving SMMC the opportunity to participate in a study to assess the safety and/or efficacy of Two Dose Levels of Interferon alfacon-1 (Infergen®, CIFN) Plus Ribavirin Administered for 48 Wks vs. No Treatment in Hepatitis C Infected Patients who are non-responders to previous Pegylated Interferon Alfa Plus Ribavirin therapy.
Performance Measures
Measures
(at end of first year)
2004-2005
Objectives
Percentage of project client goal (10 persons) recruited and assessed for this study.
100%
Percentage of project client’s dosage comparisons completed for this study.
100%
Percentage of project clients with positive response to trial medications
75%
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Background
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The Clinical Trials and Research Unit of the San Mateo County Health 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 Hepatitis C as a problem affecting many of the County’s patients with HIV. The Clinical Trials and Research Unit discovered that patients are not responding to the current drug treatments. This trial will evaluate patient’s response to this new drug treatment.
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Discussion
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In October 2004 InterMune, Inc. contacted the Clinical Trials and Research Unit to participate in a Multi-center Study for patients with Hepatitis C. On January 14, 2004, the InterMune, Inc. notified the County that our site was selected to participate in the clinical trial. The County will receive $69,780 for fiscal year 2004-2005.
The primary purpose of this study is to assess the safety and effectiveness of Two Dose Levels of Interferon alfacon-1 (Infergen®, CIFN) Plus Ribavirin Administered for 48 Wks vs. No Treatment in Hepatitis C Infected Patients who are non-responders to previous Pegylated Interferon Alfa Plus Ribavirin Therapy.
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Fiscal Impact
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The term of the study is February 3, 2005 to February 3, 2007. This total amount of the award is $69,780. 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.
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