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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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July 21, 2008
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BOARD MEETING DATE:
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September 9, 2008
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SPECIAL NOTICE/HEARING:
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None
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VOTE REQUIRED:
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Majority
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TO:
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Honorable Board of Supervisors
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FROM:
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Sang-ick Chang, M.D., Chief Executive Officer, San Mateo Medical Center
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SUBJECT:
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Agreements with PPD Development, LP
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RECOMMENDATION:
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Adopt a Resolution:
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1.
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Authorizing the execution of an Agreement with PPD Development, LP to conduct a clinical research study to evaluate the efficacy and safety of Clevudine compared to Adefovi in treating patients with HBeAG Positive Chronic Hepatitis due to Hepatitis B Virus in accordance with Sponsor’s protocol no. CI-PSI-5268-06-305 for a term of 96 weeks from the date the Agreement is fully executed, in an amount not to exceed $106,468.75.
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2.
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Authorizing the execution of an Agreement with PPD Development, LP to conduct a clinical research study to evaluate the efficacy and safety of Clevudine compared to Adefovi in treating patients with HBeAG Negative Chronic Hepatitis due to Hepatitis B Virus in accordance with Sponsor’s protocol no. CI-PSI-5268-06-306 for a term of 96 weeks from the date the Agreement is fully executed, in an amount not to exceed $106,468.75.
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3.
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Authorizing the Chief Executive Officer of San Mateo Medical Center (SMMC) or the CEO’s designee to execute contract Amendments to either or both of the Agreements which modify the County’s maximum fiscal obligation by no more than $25,000 (in aggregate), and/or modify the contract term and/or services so long as the modified term of services is/are within the current or revised fiscal provisions.
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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.
The agreements contribute to this commitment and goal by giving SMMC the opportunity to pursue efforts to find new drug therapies. These studies will evaluate the efficacy and safety of Clevudine compared to Adefovi in treating patients with HBeAG Positive and Negative Chronic Hepatitis due to Hepatitis B Virus.
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Performance Measure(s):
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Measure
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FY 2008-09
Projected
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FY 2009-10
Projected
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Number of patients recruited and assessed for each study
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5
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5
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Percent of enrolled patients completing trial with positive response to trial medications
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75%
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75%
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BACKGROUND/DISCUSSION:
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The Clinical Trials and Research Unit was established to provide a mechanism and infrastructure for the conduct of clinical trials and medical or psychosocial research projects for the benefit of the residents of San Mateo County. A preliminary assessment conducted by the Clinical Trials and Research Unit identified Hepatitis B as a problem affecting many of the County patients who are not responding to current drug treatments.
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On March 2008, PPD Development, LP requested that the Clinical Trials and Research Unit participate in two clinical research studies that explore new drug therapies for SMMC patients with Hepatitis B. Administrative oversight, technical assistance, and project monitoring will be provided by existing Clinical Trials and Research Unit. The County will receive $21,293.75 per patient enrolled in each study, in an amount not to exceed $106,468.75 per study. There is a separate agreement for each study and the maximum total amount receivable by the County under the two agreements is
$212,937.50.
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County Counsel and Risk Management have reviewed and approved these Agreements.
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TERM AND FISCAL IMPACT:
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The term of each Agreement with PPD Development to conduct Clinical Research Studies Protocol No. CI-PSI-5268-06-305 and Protocol No. CI-PSI-5268-06-306 is 96 weeks from the date each Agreement is fully executed, in an amount not to exceed $106,468.75 per study. For a total of $212,937.50 for the two agreements combined. There is no net county cost associated with these studies.
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