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21st century cures : modernizing clinical trials : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Thirteenth Congress, second session, July 9, 2014
| 21st century cures : modernizing clinical trials : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Thirteenth Congress, second session, July 9, 2014 |
| Pubbl/distr/stampa | Washington : , : U.S. Government Publishing Office, , 2015 |
| Descrizione fisica | 1 online resource (iv, 165 pages) |
| Soggetto topico |
Clinical trials - United States
Drugs - United States - Testing Medical instruments and apparatus - United States - Testing Clinical trials Drugs - Testing Medical instruments and apparatus - Testing |
| Soggetto genere / forma | Legislative hearings. |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | 21st century cures |
| Record Nr. | UNINA-9910703523803321 |
| Washington : , : U.S. Government Publishing Office, , 2015 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Access to investigational drugs [[electronic resource] ] : questions and answers
| Access to investigational drugs [[electronic resource] ] : questions and answers |
| Pubbl/distr/stampa | [Bethesda, Md.] : , : National Cancer Institute, , [2004] |
| Descrizione fisica | 6 pages : digital, PDF file |
| Collana | Fact sheet |
| Soggetto topico |
Health services accessibility
Clinical trials |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Access to Investigational Drugs |
| Record Nr. | UNINA-9910698556403321 |
| [Bethesda, Md.] : , : National Cancer Institute, , [2004] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Access to non-summary clinical trial data for research purposes under EU law / / Daria Kim
| Access to non-summary clinical trial data for research purposes under EU law / / Daria Kim |
| Autore | Kim Daria |
| Pubbl/distr/stampa | Cham, Switzerland : , : Springer, , [2021] |
| Descrizione fisica | 1 online resource (310 pages) |
| Disciplina | 342.240662 |
| Collana | Munich studies on innovation and competition |
| Soggetto topico |
Freedom of information - European Union countries
Clinical trials Freedom of information |
| ISBN | 3-030-86778-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Intro -- Preface -- Acknowledgements -- Contents -- Abbreviations -- Chapter 1: Introduction -- References -- Part I: Setting the Scene -- Chapter 2: The Context and the Problem -- 2.1 Clinical Trials: General Aspects -- 2.1.1 Basic Definitions -- 2.1.2 The Social Value of Clinical Trials -- 2.1.3 Clinical Trials in the Regulatory Context -- 2.1.3.1 Clinical Trial Approval -- 2.1.3.2 Drug Marketing Authorisation -- 2.1.4 Clinical Trials as a Part of Industry RandD -- 2.2 The Debate Over Access to Clinical Trial Data -- 2.2.1 Concerns Related to Restricted Access to Clinical Trial Data -- 2.2.2 Transparency Issues -- 2.2.3 Levels of Transparency in Clinical Trials -- 2.2.3.1 Trial Registration -- 2.2.3.2 Reporting and Publication of Trial Results -- 2.2.3.3 Accessibility of Non-Summary Data -- 2.2.4 International Norm-Setting Initiatives Promoting Transparency in Clinical Research -- 2.2.5 Institutional Developments -- 2.2.5.1 Editorial Campaign -- 2.2.5.2 Funding Institutions -- 2.2.6 Access to Data as a Digital Resource in the Context of Data-Driven Innovation -- 2.2.6.1 The Promises of `Big Data´ -- 2.2.6.2 Legal and Policy Debate Concerning `Ownership´ of Sensor-Generated Data -- 2.2.6.3 `Big Data´ Analysis in Public Healthcare and Drug RandD -- 2.2.6.4 Data-Sharing Policies and Practices Adopted by the Pharmaceutical Industry -- 2.3 Diversity of Policy Approaches and Academic Views -- 2.3.1 The Controversy Over Disclosure of Non-Summary Clinical Trial Data in the EU -- 2.3.1.1 Investigations of the European Ombudsman -- 2.3.1.2 The EMA Transparency Policies -- 2.3.1.3 Evolving Case Law of the CJEU on Clinical Trial Data Disclosure -- 2.3.2 Policy Approaches in Other Jurisdictions -- 2.3.3 Academic Discourse -- 2.3.3.1 General Medical Literature -- 2.3.3.2 Legal Discourse on Access to Clinical Trial Data.
Removing Financial Ties with the Industry -- Disclosure as a quid pro quo for Data Exclusivity Protection -- Amending the Freedom of Information Legislation -- 2.3.3.3 Comparative and International Law Perspectives -- 2.4 The Present Study Against the Background of Policy and Legal Discourse -- References -- Chapter 3: Secondary Analysis of Individual Patient-Level Clinical Trial Data: A Primer -- 3.1 Clinical Trial Data -- 3.1.1 Definitions and General Aspects -- 3.1.2 The Types of Clinical Trial Data -- 3.1.3 The `Life-Cycle´ of Clinical Trial Data -- 3.2 Clinical Trial Data as a Source of Medical Knowledge -- 3.2.1 Clinical Trial Data as a Source of Scientific Knowledge -- 3.2.2 The Types of Data Analyses -- 3.2.2.1 Primary and Secondary Data Analyses -- 3.2.2.2 Confirmatory Secondary Data Analysis -- 3.2.2.3 Exploratory Secondary Analysis -- 3.2.2.4 Subgroup Data Analysis -- 3.2.2.5 Interaction Analysis -- 3.2.2.6 Predictive Models and Prognostic Variables -- 3.2.2.7 Meta-analysis and Systematic Reviews -- 3.2.3 Fields of Research -- 3.2.3.1 Pharmacology -- 3.2.3.2 Epidemiology, Clinical Epidemiology and Pharmacoepidemiology -- 3.2.3.3 Aetiology, Pathology and Pathophysiology -- 3.2.3.4 Research on Biomarkers -- 3.3 Exploratory Analysis of Clinical Trial Data in Drug RandD -- 3.3.1 `Data-Driven´ Drug RandD -- 3.3.2 The Application of Data Analytics in Drug Discovery -- 3.3.3 Secondary IPD Analysis in Planning and Design of New Trials -- 3.3.4 Secondary Analysis of Data from Unsuccessful Trials -- 3.4 Secondary Data Analysis by Drug Regulators -- 3.4.1 Advancing Regulatory Science -- 3.4.2 Extrapolation -- 3.5 Conclusion on Chapter 3 -- References -- Part II: Analysis De Lege Lata -- Chapter 4: Legal Sources of Control Over and Access to Clinical Trial Data Under the EU Applicable Framework. 4.1 The EU Legal and Regulatory Framework Applicable to Clinical Trial Data -- 4.1.1 Relevant Provisions Under Primary Law -- 4.1.2 Relevant Sources of Secondary Law -- 4.1.2.1 The EU Regulation on Clinical Trials -- General Aspects -- Data Reliability and Robustness -- The EU Database for Clinical Trial Data -- 4.1.2.2 The EU Drug Authorisation Regulation -- 4.1.2.3 The EMA´s Guidance on the Implementation of the Publication Policy -- 4.2 Legal Sources of Control of Trial Sponsors Over Individual Patient-Level Clinical Trial Data -- 4.2.1 Do Drug Sponsors `Own´ Clinical Trial Data? -- 4.2.1.1 Competing Claims of Data Ownership -- 4.2.1.2 De facto Control But Not de jure Ownership of IPD -- The Obligation to Protect Data Against Unauthorised Access as the Source of de facto Exclusive Control -- No Property Rights in IPD as Personal Data -- No in rem Rights in Sensor-Generated Data -- Data Fixed and Stored in a Material Medium -- 4.2.2 The Applicability of the EU Trade Secrets Directive to Non-summary Clinical Trial Data -- 4.2.2.1 The Legal Definition of a Trade Secret -- 4.2.2.2 The Applicability of Trade Secret Protection to CSRs -- 4.2.2.3 The Applicability of Trade Secret Protection to IPD -- The Secrecy Requirement -- The Requirement of Commercial Value Due to Secrecy -- The Requirement of Protection Measures to Preserve Secrecy -- 4.2.3 The Applicability of the EU Database Directive to IPD -- 4.2.3.1 IPD from an Individual Trial -- 4.2.3.2 The Applicability of the Copyright Type of Database Protection -- 4.2.3.3 The Applicability of the sui generis Database Right -- 4.2.4 Data Exclusivity Protection -- 4.2.4.1 The Abridged Procedure for Drug Marketing Authorisation -- 4.2.4.2 Data Exclusivity as a Temporary Derogation from the Abridged Procedure -- 4.2.4.3 The Nature and Scope of Test Data Exclusivity Protection. 4.2.5 Contractually Obtained Exclusive Control -- 4.2.5.1 Contractual Practice Related to Obtaining Clinical Trial Data -- 4.2.5.2 Implications of Contractually Defined `Exclusive Property´ in Trial Data -- 4.3 Access Regimes Applicable to Clinical Trial Data -- 4.3.1 Regulatory Requirements for Clinical Trial Data Disclosure -- 4.3.1.1 What Data Is (Supposed to Be) in the Public Domain? -- 4.3.1.2 Uncertainty Regarding the Definition of CCI -- 4.3.2 The Relevance of the Right of Access to Personal Data -- 4.3.3 Access to IPD Under the Right of Access to Documents -- 4.3.3.1 The Right of Access to Documents Held by Public Authorities -- 4.3.3.2 The Exception for Protection of Commercial Interests in the Case of Clinical Trial Data -- The Exception for Protection of Commercial Interests -- The Existence of the General Presumption of Confidentiality for CSRs -- 4.3.3.3 Implications for the Publication of Clinical Trial Data in the EU Database -- 4.3.3.4 Limitations of the Right of Access to Documents as an Instrument of Access to IPD for Research Purposes -- 4.3.4 Competition Law as an (Unsuitable) Instrument of Access to IPD -- 4.3.4.1 Access to IPD as a Hypothetical Case on a Refusal to Deal -- 4.3.4.2 The Assessment of a Refusal to Grant Access to IPD for Exploratory Analysis Under Article 102 of the TFEU -- The Standard of Intervention Where Access to Information or Data Is Refused -- The Dominance of the IPD Holder -- IPD Indispensability for Exercising an Activity on a Neighbouring Market -- The Exclusion of Effective Competition in a Neighbouring Market -- The Appearance of a New Product for Which There Is Potential Consumer Demand -- The Objective Justification of a Refusal -- 4.3.4.3 Conclusion on the Application of Competition Law -- 4.4 Conclusion on Chapter 4 -- References. Chapter 5: Implications of IPD Disclosure for Statutory Innovation Incentives -- 5.1 The Impediment-to-Innovation-Incentives Claim -- 5.1.1 Arguments Submitted During the EMA Public Consultation -- 5.1.2 Arguments Raised Before the CJEU -- 5.1.3 Restrictive Provisions Under the Industry Data-Sharing Policies -- 5.2 Dissecting the Claim -- 5.2.1 Innovation -- 5.2.2 Innovation Incentives -- 5.2.3 The Problem of Appropriability in Drug Innovation -- 5.2.4 Innovation Incentives -- 5.2.4.1 Patents and SPCs -- 5.2.4.2 Incentive Instruments Under the Sector Legislation -- 5.3 Implications of IPD Disclosure for Patent Protection -- 5.3.1 Concerns of Drug Companies -- 5.3.2 Implications of Non-summary Clinical Trial Data Disclosure for Patentability -- 5.3.2.1 Novelty -- 5.3.2.2 Inventive Step -- 5.3.2.3 Summary of Implications of Data Disclosure for Patentability -- 5.3.2.4 Implications of Disclosure for SPC Protection -- 5.4 Implications of IPD Disclosure for Sector-Specific Incentives -- 5.4.1 Implications of Data Disclosure for Data Exclusivity Protection in the EU -- 5.4.1.1 Concerns Regarding the Circumvention of Data Exclusivity Protection -- 5.4.1.2 Implications of Data Disclosure for Test Data Exclusivity Protection in the EU -- 5.4.1.3 The Risk of Misusing Disclosed Data Outside of the EU -- 5.4.2 Implications of Data Disclosure for Orphan Drug Exclusivity -- 5.5 Conclusion on Chapter 5 -- References -- Part III: Analysis De Lege Ferenda: Exclusively Controlled or Readily Accessible? -- Chapter 6: Defining the Intervention Logic of Access-To-Data Measures: A Problem Analysis -- 6.1 General Principles of Regulatory Intervention -- 6.1.1 Regulatory Intervention as an Exception -- 6.1.2 The Grounds for Policy Intervention -- 6.1.3 Social Welfare as a Normative Benchmark -- 6.1.4 Necessity and Proportionality as the Guiding Principles. 6.2 The European Commission´s Methodology for Problem Analysis. |
| Record Nr. | UNINA-9910506380003321 |
Kim Daria
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| Cham, Switzerland : , : Springer, , [2021] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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AmfAR global link
| AmfAR global link |
| Pubbl/distr/stampa | New York, NY, : American Foundation for AIDS Research |
| Soggetto topico |
AIDS (Disease) - Treatment
HIV infections - Treatment Clinical trials HIV Infections - drug therapy Acquired Immunodeficiency Syndrome - drug therapy Antiviral Agents |
| Soggetto genere / forma |
Directories.
Periodicals. |
| ISSN | 1540-3173 |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | American Foundation for AIDS Research global link |
| Record Nr. | UNINA-9910144224303321 |
| New York, NY, : American Foundation for AIDS Research | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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AmfAR global link
| AmfAR global link |
| Pubbl/distr/stampa | New York, NY, : American Foundation for AIDS Research |
| Soggetto topico |
AIDS (Disease) - Treatment
HIV infections - Treatment Clinical trials HIV Infections - drug therapy Acquired Immunodeficiency Syndrome - drug therapy Antiviral Agents |
| Soggetto genere / forma |
Directories.
Periodicals. |
| ISSN | 1540-3173 |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | American Foundation for AIDS Research global link |
| Record Nr. | UNISA-996218453503316 |
| New York, NY, : American Foundation for AIDS Research | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. di Salerno | ||
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Analysis of data from randomized controlled trials : a practical guide / / Jos W. R. Twisk
| Analysis of data from randomized controlled trials : a practical guide / / Jos W. R. Twisk |
| Autore | Twisk Jos W. R. <1962-> |
| Pubbl/distr/stampa | Cham, Switzerland : , : Springer, , [2021] |
| Descrizione fisica | 1 online resource (167 pages) |
| Disciplina | 616.027 |
| Soggetto topico |
Clinical trials
Assaigs clínics |
| Soggetto genere / forma | Llibres electrònics |
| ISBN | 3-030-81865-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910502594203321 |
|
Twisk Jos W. R. <1962->
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| Cham, Switzerland : , : Springer, , [2021] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Analysis of data from randomized controlled trials : a practical guide / / Jos W. R. Twisk
| Analysis of data from randomized controlled trials : a practical guide / / Jos W. R. Twisk |
| Autore | Twisk Jos W. R. <1962-> |
| Pubbl/distr/stampa | Cham, Switzerland : , : Springer, , [2021] |
| Descrizione fisica | 1 online resource (167 pages) |
| Disciplina | 616.027 |
| Soggetto topico |
Clinical trials
Assaigs clínics |
| Soggetto genere / forma | Llibres electrònics |
| ISBN | 3-030-81865-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNISA-996466413903316 |
|
Twisk Jos W. R. <1962->
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| Cham, Switzerland : , : Springer, , [2021] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. di Salerno | ||
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Analyzing longitudinal clinical trial data : a practical guide / / by Craig Mallinckrodt and Ilya Lipkovich
| Analyzing longitudinal clinical trial data : a practical guide / / by Craig Mallinckrodt and Ilya Lipkovich |
| Autore | Mallinckrodt Craig H. <1958, > |
| Pubbl/distr/stampa | Boca Raton, FL : , : Chapman and Hall/CRC, an imprint of Taylor and Francis, , 2016 |
| Descrizione fisica | 1 online resource (330 pages) : illustrations, tables |
| Disciplina | 615.5072/4 |
| Collana | Chapman & Hall/CRC Biostatistics Series |
| Soggetto topico | Clinical trials |
| ISBN |
1-351-73768-6
1-315-18663-2 1-351-73769-4 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Cover -- Half Title -- Title Page -- Copyright Page -- Table of Contents -- Preface -- Acknowledgments -- List of Tables -- List of Figures -- List of Code Fragments -- Section I: Background and Setting -- 1: Introduction -- 2: Objectives and Estimands�Determining What to Estimate -- 3: Study Design�Collecting the Intended Data -- 4: Example Data -- 5: Mixed-Effects Models Review -- Section II: Modeling the Observed Data -- 6: Choice of Dependent Variable and Statistical Test -- 7: Modeling Covariance (Correlation) -- 8: Modeling Means Over Time -- 9: Accounting for Covariates -- 10: Categorical Data -- 11: Model Checking and Verification -- Section III: Methods for Dealing with Missing Data -- 12: Overview of Missing Data -- 13: Simple and Ad Hoc Approaches for Dealing with Missing Data -- 14: Direct Maximum Likelihood -- 15: Multiple Imputation -- 16: Inverse Probability Weighted Generalized Estimated Equations -- 17: Doubly Robust Methods -- 18: MNAR Methods -- 19: Methods for Incomplete Categorical Data -- Section IV: A Comprehensive Approach to Study Development and Analyses -- 20: Developing Statistical Analysis Plans -- 21: Example Analyses of Clinical Trial Data -- References -- Index. |
| Record Nr. | UNINA-9910155108403321 |
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Mallinckrodt Craig H. <1958, >
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| Boca Raton, FL : , : Chapman and Hall/CRC, an imprint of Taylor and Francis, , 2016 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Applied clinical trials
| Applied clinical trials |
| Pubbl/distr/stampa | Eugene, OR, : Aster Pub. Co |
| Disciplina | 615 |
| Soggetto topico |
Clinical trials
Clinical Trials as Topic Medicine |
| Soggetto genere / forma |
Periodical
Periodicals. |
| ISSN | 2150-623X |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Record Nr. | UNISA-996336181903316 |
| Eugene, OR, : Aster Pub. Co | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. di Salerno | ||
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Asia Pacific journal of clinical trials: nervous system diseases
| Asia Pacific journal of clinical trials: nervous system diseases |
| Pubbl/distr/stampa | Mumbai : , : Wolters Kluwer - Medknow, , 2016- |
| Descrizione fisica | 1 online resource |
| Disciplina | [E] |
| Soggetto topico |
Nervous system - Diseases
Clinical trials |
| Soggetto genere / forma | Periodicals. |
| ISSN | 2542-3940 |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Altri titoli varianti |
Nervous system diseases
CTNSD ACTN journal Asia Pac. clin. transl. nerv. syst. dis. Asia Pac. j. clin. trials nerv. syst. dis. Asia Pacific clinical and translational nervous system diseases |
| Record Nr. | UNINA-9910444358903321 |
| Mumbai : , : Wolters Kluwer - Medknow, , 2016- | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Soggetto topico
-
Clinical trials
(244)
- Clinical Trials as Topic (26)
- Drugs - Testing (25)
- Medicine - Research (11)
- Clinical medicine - Research (9)