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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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October 23, 2006
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BOARD MEETING DATE:
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November 14, 2006
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SPECIAL NOTICE/HEARING:
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Majority
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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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Agreement with PPD Development, LP
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RECOMMENDATION:
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1. 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 $38,390 to conduct a clinical study with hepatitis B patients who are lamivudine resistant
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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 1, 2006 through December 31,2008, in an amount not to exceed $38,390
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2.
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Approve an Appropriation Transfer Request (ATR) to accept unanticipated revenue in an amount not to exceed $38,390 for FY2006-07 and appropriate new revenue to Clinical Trials and Research ($38,390)
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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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The Agreement contributes to this commitment and goal by giving SMMC patients the opportunity to participate in a study that may improve their condition.
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Performance Measure(s):
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Measure
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FY 2006-07
Projected
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FY2007-08
Projected
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Number of persons recruited and assessed for this study
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5
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5
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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 five patients will be enrolled in the study. It is anticipated that 75% of these patients will have a positive reaction to this regimen.
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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 B 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 patients’ response to this new drug treatment.
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DISCUSSION:
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In September 2006 PPD Development, LP, contacted the Clinical Trials and Research Unit to participate in a clinical trial for patients with Hepatitis B. On September 2006, PPD Development notified the County that our site was selected to participate in the clinical trial. The County will receive up to $38,390 for fiscal year 2006-2007, if we are able to enroll 5 patients into the study.
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The primary purpose of this study is to evaluate the efficacy and safety of combination therapy used in the study with Hepatitis B patients.
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FISCAL IMPACT:
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The grant from PPD Development will not exceed $38,390. The term of the Agreement is from September 1, 2006 through December 31, 2008. 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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