Il giudice specializzato in materia d'impresa : problemi e prospettive / / Paolo Comoglio

• Record Nr.: UNINA9910467716003321
• Autore: Comoglio Paolo
• Pubbl/distr/stampa: Torino, [Italy] : , : G. Giappichelli Editore, , 2014; ©2014
• ISBN: 88-921-5463-X
• Descrizione fisica: 1 online resource (280 pages)
• Collana: Professione e diritto ; ; 5
• Disciplina: 346.45065
• Soggetti: Business enterprises - Law and legislation - Italy; Commercial courts - Italy; Electronic books.
• Lingua di pubblicazione: Italiano
• Formato: Materiale a stampa
• Livello bibliografico: Monografia

Patient outcomes research teams : managing conflict of interest / / Committee on Potential Conflicts of Interest in Patient Outcomes Research Teams, Institute of Medicine ; Molla S. Donaldson and Alexander M. Capron, editors

• Record Nr.: UNINA9910973711103321
• Pubbl/distr/stampa: Washington, D.C., : National Academy Press, 1991
• ISBN: 9786610203819; 9781280203817; 1280203811; 9780309583244; 0309583241; 9780585143316; 0585143315
• Edizione: [1st ed.]
• Descrizione fisica: xii, 170 p
• Altri autori (Persone): DonaldsonMolla S; CapronAlexander Morgan
• Disciplina: 362.1/042
• Soggetti: Outcome assessment (Medical care) - United States
• Lingua di pubblicazione: Inglese
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Note generali: Bibliographic Level Mode of Issuance: Monograph
• Nota di bibliografia: Includes bibliographical references (p. 93-97).
• Nota di contenuto: Patient Outcomes Research Teams: Managing Conflict of Interest -- Copyright -- Acknowledgments -- Preface -- Contents -- Summary -- INSTITUTE OF MEDICINE STUDY -- DEFINING CONFLICT OF INTEREST -- MODELS FOR ADDRESSING CONFLICTS OF INTEREST -- POINTS TO CONSIDER -- 1 Introduction -- OUTCOMES RESEARCH -- THE INSTITUTE OF MEDICINE STUDY -- STRUCTURE OF THE REPORT -- 2 Patient Outcomes Research Teams -- THE MEDICAL TREATMENT EFFECTIVENESS PROGRAM -- PORT RESEARCH TOPICS -- PORT STRUCTURE -- PORT METHODS -- SPECIAL ASPECTS OF PORT RESEARCH -- SUMMARY -- 3 Conflict of Interest -- DEFINING CONFLICT OF INTEREST -- FINANCIAL RELATIONSHIPS THAT MAY GIVE RISE TO CONFLICTS OF INTEREST -- Equity and Other Financial Relationships -- Industry Support for University Research -- ACADEMIC AND PROFESSIONAL CONFLICTS OF INTEREST -- ADDRESSING ; CONFLICTS OF INTEREST -- Legislative Support for Technology Transfer -- EFFECTS OF UNIVERSITY-INDUSTRY COLLABORATION -- RELEVANT EFFORTS IN OTHER SECTORS -- Regulation or Federal Employees -- FDA Federal Advisory Committees -- The United States Pharmacopeial Convention -- Professional Associations -- National Research Council -- National Institutes of Health Grants Policy -- Academic Association and Institutional Guidelines -- AAMC Guidelines -- AAHC Guidelines -- Academic Institutional Guidelines -- Medical Publications -- Judicial and Legal Approaches -- SUMMARY -- 4 Sources of Concern About Conflicts of Interest in PORTs -- ELEVEN ISSUES OF SPECIAL CONCERN -- PORTs as Hybrid Entities: Research and Quasi-Regulatory Functions -- PORTs as a Public Trust for Development of Scientific Knowledge -- PORTs as a Quasi-Regulatory Process -- Protecting PORT Credibility -- Expectations of Cost Savings -- Concentration of Expertise -- Subjective Judgments and Multidimensional Outcome Assessments.; Biases Arising from Ties to Professional Colleagues and Associations -- Access to Data -- Adequacy of Existing Institutional Guidelines -- Multi-Institutional PORTs -- Nonuniversity Clinicians and Their Patients -- Private Funding for Technological Modifications and New Practices -- Additional Study Arms -- Secondary Protocols -- Consulting and Other Financial Arrangements -- Spin-Off Ventures and Intellectual Property Rights -- Equity Interests of PORT Investigators -- Freedom of Communication Within PORTs -- SUMMARY -- 5 Managing Conflicts of Interest: General Models and Approaches -- TWO MODELS OF CONFLICT OF INTEREST MANAGEMENT -- Prohibition Model -- Disclosure and Peer Review Model -- GENERAL APPROACHES TO DEALING WITH CONFLICTS OF INTEREST -- Disclosure -- Financial Distancing -- Self-Regulation -- Defining Categories of Acceptable Activities and Implementing Oversight -- Defining Categories of Unacceptable Activities and Implementing Prohibitions -- Sanctions -- SUMMARY -- 6 Points to Consider -- ASSUMPTION -- CONSIDERATIONS FOR PORTS AND THEIR INSTITUTIONS -- Attributes of Conflict of Interest Management -- Education for Researchers, Faculty, and Students -- Clearly Stated Expectations for Early and Complete Disclosure -- Well-Formulated and Well-Implemented Institutional Processes and Responses -- Emphasis on the Role of the Principal Investigator -- Professional Conflicts and Implications for PORT Research -- Freedom of Communication for PORT Researchers -- CONSIDERATIONS FOR AHCPR -- Industry-Sponsored Research -- Access to Data -- Intra- and Inter-PORT Differences -- Review of Grant Applications -- CONSIDERATIONS FOR THE HEALTH SERVICES RESEARCH COMMUNITY -- CONSIDERATIONS FOR INDUSTRY -- Publication and Communication of Findings among PORT Members and Industry -- CONSIDERATIONS FOR CONGRESS -- CONCLUDING REMARKS -- References.; Appendix A Institute of Medicine Workshop on Conflicts of Interest in Patient Outcomes Research Teams -- PROGRAM AND SUMMARY -- Appendix B Workshop Participants -- INVITED PARTICIPANTS -- PRESS REPRESENTATIVE -- INSTITUTE OF MEDICINE -- Appendix C Scenarios and Rapporteur Summaries -- APPENDIX C1. SCENARIO I -- Discussion of Scenario I -- APPENDIX C2. SCENARIO II -- CARDPAK: Start of Study -- Outside Activities of the PORT Members -- Preliminary Results of the PORT Analyses: Four Years into the Study -- Discussion of Scenario II -- APPENDIX C3. SCENARIO III -- Discussion of Scenario III -- Appendix D Background Papers -- APPENDIX D1. PORT RESEARCH COMPARED WITH CLINICAL RESEARCH: CONFLICTS OF INTEREST IN PATIENT OUTCOME RESEARCH -- Introduction -- Patient Outcomes Research Teams -- Conflicts of Interest in Patient Outcomes Research Teams -- ; Opportunity and Motive -- Traditional Conflicts of Interest: Funding, Consulting, and Equity -- Spinoff Ventures and Intellectual Property Rights -- Changing Stakeholders -- Conclusions: What's Different about Outcomes Research? -- References -- APPENDIX D2. PORTS: THEIR IMPACT ON HEALTH SERVICES RESEARCH, TECHNOLOGY INNOVATION, AND PAYMENT POLICY -- Introduction -- Health Services Research -- Structure -- Possible Threats to PORT Success -- Cost of the PORTS -- Concentration of Expertise -- Technology Innovation -- Payment Policy -- Kinds of Uses for Information -- Magnitude of Impact -- Discussion -- Conclusions -- References -- APPENDIX D3. THE EVOLUTION AND CURRENT STATUS OF CONFLICT OF INTEREST REGULATION IN BIOMEDICAL SCIENCE -- Introduction -- Historical Overview -- Recent Concerns Regarding Clinical Studies -- NIH Activity in the Area -- Recent Self-Regulation in Clinical Studies -- Recent Moves by Consortia and Individual Institutions -- Conclusions and Applications to the PORTs -- Notes.; APPENDIX D4. THE STRUCTURE AND METHODS OF PORTS: SOURCES OF BIAS -- PORT Mission -- Experiences of the Dartmouth Assessment Team -- Vulnerability of PORT Mission to Conflict of Interest and Corruption of Purpose -- Economic Conflict of Interest -- Ideological Corruption -- Existential Corruption -- Corruption of Discursive Practices.
• Sommario/riassunto: The new Agency for Health Care Policy and Research in the U.S. Public Health Service is funding a set of multidisciplinary groups called Patient Outcomes Research Teams (PORTs). Their purpose is to assess alternative treatments for medical conditions using a variety of outcome measures. In guiding insurance coverage, these PORTs are expected to wield considerable influence on medical practice and health policy. This book addresses possible threats to their credibility that might be based on real or apparent conflicts of interest, including both financial and other conflicts. It raises points to consider for the new agency, for PORTs and their institutions, for industry, for the health services research community, and for the U.S. Congress in avoiding and managing conflicts of interest.