
Contents
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13 Other Issues in Statistics I: Missing Data, Intention-to-Treat Analysis, and Covariate Adjustment
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Introduction Introduction
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The Partnership Between Academia and Industry The Partnership Between Academia and Industry
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Sources of Conflicts Between Academia and Industry Sources of Conflicts Between Academia and Industry
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Reasons for Partnership Between Academia and Industry Reasons for Partnership Between Academia and Industry
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Clinical Trial Agreement Clinical Trial Agreement
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Cost and Payments Cost and Payments
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Government Funding Mechanisms for Industry Government Funding Mechanisms for Industry
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Contract Provisions Contract Provisions
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Intellectual Property Intellectual Property
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Publications Publications
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Indemnification Indemnification
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Medical Care in the Case of an Adverse Event Medical Care in the Case of an Adverse Event
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Case Study: The Business of Clinical Research—A Standoff in the City of Lights Case Study: The Business of Clinical Research—A Standoff in the City of Lights
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Goethe’s Faust Goethe’s Faust
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The Other Side: Academia The Other Side: Academia
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The Negotiation Table The Negotiation Table
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Case Discussion Case Discussion
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Case Questions for Reflection Case Questions for Reflection
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Further Reading Further Reading
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References References
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Cite
Abstract
This chapter presents a series of important topics that should be considered and evaluated before conducting a clinical trial in which there is a collaboration between industry and academia. It discusses important topics such as the project budget and sources of funding. Additionally, this chapter highlights the advantages of the academia-industry partnership, potential conflicts of interest, and, in the advent of a conflict of interest, strategies to minimize its effects. Intellectual property, indemnifications, publication, and other specific issues are also presented as key elements in a clinical trial agreement. A clinical case is used to exemplify and discuss the practical aspects of this challenging negotiation.
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