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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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September 23, 2005
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BOARD MEETING DATE:
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October 18, 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 PPD Development, LP
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RECOMMENDATION:
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Adopt a Resolution:
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A.
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Accepting a grant from the PPD Development, LP in an amount not to exceed $97,220 to conduct a clinical study entitled “Analysis of Hepatitis C Viral Kinetics and Viramidine Pharmacokinetics Utilizing Two Treatment Regimens in Therapy-Naïve Patients with Chronic Hepatitis C”
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B.
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Authorizing the execution of an Agreement with PPD Development, LP to conduct the clinical trial for the term September 9, 2005 to September 9, 2007, in an amount not to exceed $97,220
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C.
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Approving an Appropriation Transfer Request (ATR) to accept unanticipated revenue (in an amount not to exceed $97,220) for FY2005-06 and appropriate new revenue to Clinical Trials and Research ($97,220)
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VISION ALIGNMENT:
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Commitment: Ensure basic health and safety for all.
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Goal 8: Help vulnerable people – the aged, disabled, mentally ill, at risk youth and others – achieve a better quality of life.
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This grant contributes to this commitment and goal by giving SMMC the opportunity to participate in a study to analyze Hepatitis C Viral Kinetics and Viramidine Pharmacokinetics using two treatment regimen in therapy-naive patients with chronic Hepatitis C.
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Performance Measure(s):
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Measure
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FY 2005-06
Projected
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FY2006-07
Projected
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Number of persons recruited and assessed for this study
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9
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9
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Percent of project client’s dosage comparisons completed for this study.
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100%
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100%
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Percent of project clients with positive response to trial medications
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75%
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75%
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A maximum of nine patients will be enrolled in the study. It is anticipated the dosage comparisons for these patients will be completed and that 75% of these patients will have a positive reaction to the medication.
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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 September 2005, PPD Development, LP contacted the Clinical Trials and Research Unit to participate in a Multi-center Study for patients with Hepatitis C. On January 2005, PPD Development, LP notified the County that our site was selected to participate in the clinical trial. The County will receive an amount not to exceed $97,220 for FY2005-06.
The primary purpose of this study is to assess the safety and/or efficacy of Two Dose Levels of Daily Interferon Alfacon-1 plus Ribavirin in Hepatitis C infected patients who failed to achieve virologic response after previous Pegylated Interferon Alfa plus Ribavirin Therapy and during at least 24 Weeks of no treatment in IRHC-001.
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FISCAL IMPACT:
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The grant from PPD Development, LP will not exceed $97,220. Funds are included in the San Mateo Medical Center’s FY2005-06 Adopted Budget. The term of the Agreement is September 9, 2005 to September 9, 2007. 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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