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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 |
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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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Bayesian adaptive design for immunotherapy and targeted therapy / / by Haitao Pan, Ying Yuan
| Bayesian adaptive design for immunotherapy and targeted therapy / / by Haitao Pan, Ying Yuan |
| Autore | Pan Haitao |
| Edizione | [First edition 2023.] |
| Pubbl/distr/stampa | Singapore : , : Springer Nature Singapore : , : Imprint : Springer, , 2023 |
| Descrizione fisica | 1 online resource (XI, 262 p. 58 illus., 50 illus. in color.) : illustrations |
| Disciplina | 570.15195 |
| Soggetto topico |
Biometry
Biostatistics Clinical Trial Protocols as Topic Adaptive Clinical Trials as Topic Bayes Theorem Immunoteràpia Dianes farmacològiques Assaigs clínics Estadística matemàtica Estadística bayesiana |
| Soggetto genere / forma | Llibres electrònics |
| ISBN | 981-19-8176-0 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Introduction to Adaptive Design and Delayed Outcomes -- Basics of Bayesian Statistics -- Phase I Dose-finding Design -- Phase II Design for Interim Monitoring -- Phase I-II Dose-finding Design -- Drug Combination Trial Design -- Conclusion. |
| Record Nr. | UNINA-9910717420903321 |
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Pan Haitao
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| Singapore : , : Springer Nature Singapore : , : Imprint : Springer, , 2023 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Behavioral clinical trials for chronic diseases : scientific foundations / / Lynda H. Powell, Kenneth E. Freedland, Peter G. Kaufmann
| Behavioral clinical trials for chronic diseases : scientific foundations / / Lynda H. Powell, Kenneth E. Freedland, Peter G. Kaufmann |
| Autore | Powell Lynda H. |
| Pubbl/distr/stampa | Cham, Switzerland : , : Springer, , [2021] |
| Descrizione fisica | 1 online resource (324 pages) |
| Disciplina | 616.044 |
| Soggetto topico |
Chronic diseases
Behavior therapy - Research Chronic diseases - Treatment - Research Malalties cròniques Teràpia de la conducta Investigació mèdica Assaigs clínics |
| Soggetto genere / forma | Llibres electrònics |
| ISBN | 3-030-39330-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910502589503321 |
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Powell Lynda H.
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| Cham, Switzerland : , : Springer, , [2021] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Challenging Assumptions Around Dementia [[electronic resource] ] : User-led Research and Untold Stories / / by Rosalie Ashworth, Sue Fyvel, Alyson Hill, Chris Maddocks, Masood Qureshi, David Ross, Stuart Hay, Martin Robertson, Willy Gilder, Winnie Henry, Myra Lamont, Agnes Houston, Fred S. Wilson
| Challenging Assumptions Around Dementia [[electronic resource] ] : User-led Research and Untold Stories / / by Rosalie Ashworth, Sue Fyvel, Alyson Hill, Chris Maddocks, Masood Qureshi, David Ross, Stuart Hay, Martin Robertson, Willy Gilder, Winnie Henry, Myra Lamont, Agnes Houston, Fred S. Wilson |
| Autore | Ashworth Rosalie |
| Edizione | [1st ed. 2023.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Palgrave Macmillan, , 2023 |
| Descrizione fisica | 1 online resource (154 pages) |
| Disciplina | 616.83 |
| Altri autori (Persone) |
FyvelSue
HillAlyson MaddocksChris QureshiMasood RossDavid HayStuart RobertsonMartin GilderWilly HenryWinnie |
| Soggetto topico |
Geriatrics
Clinical psychology Nervous system - Diseases Mental health Clinical health psychology Psychology - Methodology Clinical Psychology Neurological Disorders Mental Health Health Psychology Psychological Methods Demència Assaigs clínics Testimonis |
| Soggetto genere / forma | Llibres electrònics |
| ISBN | 3-031-27223-4 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 1. Coproducing a book on dementia research -- 2. Taking part in Alzheimer’s disease research -- 3. Taking part in Vascular dementia research -- 4. Taking part in Fronto-Temporal dementia research -- 5. Taking part in Parkinson’s dementia research -- 6. Taking part in dementia with lewy bodies research -- 7. Taking part in PCA dementia research -- 8. Lessons for future research in dementia. |
| Record Nr. | UNINA-9910737295903321 |
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Ashworth Rosalie
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| Cham : , : Springer International Publishing : , : Imprint : Palgrave Macmillan, , 2023 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Fundamentals of clinical trials / / by Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger
| Fundamentals of clinical trials / / by Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger |
| Autore | Friedman Lawrence M |
| Edizione | [5th ed. 2015.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Springer, , 2015 |
| Descrizione fisica | 1 online resource (XXI, 550 p. 49 illus., 7 illus. in color.) |
| Disciplina | 610.724 |
| Soggetto topico |
Assaigs clínics
Statistics Public health Epidemiology Cancer research Oncology Statistics for Life Sciences, Medicine, Health Sciences Public Health Cancer Research Oncology |
| Soggetto genere / forma | Llibres electrònics |
| ISBN | 3-319-18539-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Introduction to Clinical Trials -- Ethical Issues -- What is the Question? -- Study Population -- Basic Study Design -- The Randomization Process -- Blinding -- Sample Size -- Baseline Assessment -- Recruitment of Study Participants -- Data Collection and Quality Control -- Assessment and Reporting of Harm -- Assessment of Health Related Quality of Life -- Participant Adherence -- Survival Analysis -- Monitoring Committee Structure & Function -- Statistical Methods Used in Interim Monitoring -- Issues in Data Analysis -- Closeout -- Reporting and Interpreting of Results -- Multicenter Trials -- Regulatory Issues. |
| Record Nr. | UNINA-9910299767003321 |
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Friedman Lawrence M
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| Cham : , : Springer International Publishing : , : Imprint : Springer, , 2015 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Leadership and management of clinical trials in creative arts therapy / / Felicity Anne Baker
| Leadership and management of clinical trials in creative arts therapy / / Felicity Anne Baker |
| Autore | Baker Felicity Anne |
| Pubbl/distr/stampa | Cham, Switzerland : , : Palgrave Macmillan, , [2022] |
| Descrizione fisica | 1 online resource (301 pages) |
| Disciplina | 616.891656 |
| Soggetto topico |
Art therapy
Teràpia artística Assaigs clínics |
| Soggetto genere / forma | Llibres electrònics |
| ISBN | 3-031-18085-2 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Intro -- Foreword -- Preface -- Acknowledgements -- Contents -- About the Author -- List of Figures -- List of Tables -- 1 Introduction -- Implementing Robust Creative Arts Therapies Trials -- Sharing Wisdom and Capacity Building -- So You Won The Grant, Now What? -- Past and Current Projects -- Study 1. Music Therapy to Aid Non-invasive Ventilation Transition for People with Motor Neuron Disease (2014-2015) -- Study 2. Singing My Story: Negotiating Identities Through Therapeutic Songwriting for People with Neurological Injuries (2015-2017) -- Study 3. MIDDEL: Music Interventions for Dementia and Depression in Elderly Care-The Australian Cohort (2017-2022) -- Study 4. HOMESIDE: Home-Based Caregiver Delivered Music Interventions for People Living with Dementia (2019-2022) -- Study 5. MATCH: Music Attuned Technology for Care via eHealth (2020-2025) -- Study 6. MAPS: Music and Psychology and Social Connections Program (2021-2022) -- Scope of the Text -- References -- 2 The Scope of Project Management -- How Out of Control Can a Controlled Trial Be? -- The Project Management Plan -- Five Phases of Clinical Trial Project Management -- Successful Management Approaches -- Good Communication Is Like the Oil in Your Engine -- Avoid Meeting Madness -- Documentation Avoids Miscommunication -- What's Happening Today: Calendar Management -- Accountability -- Problem Identification and Resolution -- Essential Clinical Trial Documents -- Study Protocol -- Manual of Operational Procedures -- Case Report Forms -- Clinical Site Management Plan -- Risk Management Plan -- Developing a Risk Assessment Plan -- Types of Risks in Trials -- Common Challenges in Clinical Trial Execution -- Balancing Complex Workloads -- Budget Constraints -- Poorly Planned Timelines -- Poor Task Prioritisation -- Conclusion -- References -- 3 The Art of Good Governance.
What Is Governance? -- Governance at Project Design Stage -- Governance at Project Authorisation Stage -- Governance at Project Implementation Stage and Project Closure -- Project Governance Committees -- Trial Management Group -- Trial Steering Committee -- Data Safety Monitoring Board -- Project Operational Committees -- Whole Team Meetings -- Smaller Working Groups and Workstreams -- Capacity Building Committee -- Statistical Analysis Plan Team -- Public and Patient Involvement Committee -- Frameworks of PPI -- Components of PPI Participation -- Reasons the Public Get Involved -- Establishing and Implementing a PPI -- Conclusion -- References -- 4 Assembling and Uniting a Team -- Staffing to Your Needs -- Principal Investigator -- Project Manager -- Clinical Trial Manager -- Biostatistician -- Health Economist -- Information Scientist -- Data Manager -- Other Team Members -- Optimising Performance: A We-ness Culture -- Empowering the Team -- Safety Within the Group -- Leading the Team -- Conclusion -- References -- 5 Budgeting for Success: Management and Resource Planning -- Barriers and Enablers to Effective Resource Management -- Preparing a Study Budget -- Project Design and Set-Up -- Project Implementation -- Models to Budget for Recruitment -- Licensing Fees -- Using Routinely Collected Data -- Trial Site Visits and Monitoring -- Governance Costs -- Data Management and Analysis -- Project Management -- Public and Patient Involvement and Public Engagement -- Knowledge Translation and Exchange, Public Engagement, and Advocacy -- Conclusion -- References -- 6 Recruitment, Retention, and Follow-Up: Frustration or Bliss -- Introduction -- Why Do People Choose to Participate in Research? -- Why Do People Decline Participation in Research? -- Health Status and Stigma -- Scepticism, Fear and Mistrust -- Family Factors -- Language Barriers. Participant Burden -- Developing and Monitoring the Recruitment Strategy -- Participants -- Developing the Research Promotional Product -- Promoting the Study -- Price -- Working with Industry Partners -- Involvement of Public and Patients in Recruitment -- Strategies to Improve Conversion Rates -- Harness Trust -- Supporting Decision Making -- Minimise Burden of Participation -- Offering Appropriate Incentives -- Working with Your Recruitment Team -- Barriers to Participant Retention and Follow-Up -- Factors to Increase Retention -- Motivating the Recruitment Team -- Conclusion -- References -- 7 Quality Data Is Power: Data Management and Monitoring -- The Need for Good Data Management and Monitoring -- Defining Quality Data -- Levels of Data Monitoring -- The Data Management Plan (DMP) -- Systems for Data Collection and Management -- Type of Data and Measures -- Data Collection Methods -- Data Entry -- Data Security -- Data Cleaning and Quality Control -- Case Report Forms -- Data Access: Roles and Responsibilities -- Data Storage -- Study Participant Monitoring -- Data Sharing and Long-Term Preservation -- Monitoring and Reporting -- Developing an Electronic Data Capture System for Your Trial -- Overview of the EDC System Development Process -- Database User Interface -- Conclusion -- References -- 8 Development, Measurement, and Validation of Intervention Fidelity -- What Is Fidelity and Why Is It Important? -- Reporting of Intervention Fidelity in Creative Arts Therapies Literature -- Conceptual Frameworks of Fidelity -- Intervention Adherence -- Assessment of Intervention Components -- Strategies to Safeguard the Quality of Intervention Delivery -- Creative Arts Therapist Competence and Training -- Intervention Supervision and Monitoring -- Methods of Monitoring Adherence and Exposure -- Treatment Receipt -- Treatment Differentiation. Treatment Enactment -- Conclusion -- References -- 9 Statistical Analysis Plan -- What Is a Statistical Analysis Plan? -- Why Does a Trial Need a Statistical Analysis Plan? -- Developing a Statistical Analysis Plan -- Statistical Analysis Plan for Observational Studies -- Missing Data -- Approaches to Treat Missing Data -- References -- 10 Development of a Knowledge Translation and Exchange Plan -- Our Ethical Responsibility to Disseminate -- What Is and Why Implement Knowledge Translation and Exchange? -- Dissemination Development Plan -- Research Findings and Products -- Identify End-Users -- Collaborating with Partners for Dissemination -- Communicating Your Message -- Evaluation of Your Dissemination Plan -- Strategies and Considerations for Implementing KTE -- Authorship and Publishing -- Publication Bias -- Conclusion -- References -- 11 Innovation, Intellectual Property, and Commercialisation -- Innovation -- Intellectual Property-Copyright, Patents, Trademarks, and Secrets -- Establishing IP Asset Segments -- Is Commercialisation a Dirty Word? -- Commercialising the Creative Arts Therapies -- Engaging with the Business Development Departments at Universities -- Assessing Commercial Potential of Your IP -- Product Development -- Step 1. Translation of IP into a Proof of Concept -- Step 2. Conceptual Design and Development of Low-Fidelity Prototype -- Step 3. Iterative Design and Evaluation of High-Fidelity Prototype -- Step 4. Production and Testing of Minimal Viable Product -- Business Development -- Competitors -- Paths to Commercialisation -- Collaborating with Industry -- Confidentiality Agreements -- Establishing a New Arm of Your Team -- A Word of Caution About Commercialisation -- Conclusion -- References -- Index. |
| Record Nr. | UNINA-9910620197803321 |
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Baker Felicity Anne
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| Cham, Switzerland : , : Palgrave Macmillan, , [2022] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Principles and practice of clinical trials / / edited by Steven Piantadosi and Curtis L. Meinert
| Principles and practice of clinical trials / / edited by Steven Piantadosi and Curtis L. Meinert |
| Pubbl/distr/stampa | Cham, Switzerland : , : Springer, , [2022] |
| Descrizione fisica | 1 online resource (2573 pages) : illustrations (some color) |
| Disciplina | 610.727 |
| Soggetto topico |
Clinical trials
Statistics Clinical trials - Statistical methods Assaigs clínics |
| Soggetto genere / forma | Llibres electrònics |
| ISBN | 3-319-52636-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Intro -- A Foreword to the Principles and Practice of Clinical Trials -- Preface -- Acknowledgments -- Contents -- About the Editors -- About the Section Editors -- Contributors -- Part I: Perspectives on Clinical Trials -- 1 Social and Scientific History of Randomized Controlled Trials -- Introduction -- Early History of Clinical Trials -- Refining Trial Methods in the Early Twentieth Century -- The Role of Governments in the Institutionalization of Randomized Controlled Trials -- Historical Trial Ethics -- RCTs and Evidence-Based Medicine -- The Globalization of RCTs and the Challenges of Similarities and Differences in Global Populations -- Social and Scientific Challenges in Randomized Controlled Trials -- Summary and Conclusion -- Key Facts -- Cross-References -- References -- 2 Evolution of Clinical Trials Science -- Introduction -- The Scientific MethodScience is the study of natural phenomena, which are accessible to both passive and active observation. P... -- Some Key Evolutionary Developments -- Ethics -- Governance ModelsRunning a clinical trial in the modern world is not simple and requires some unique governance features. Whil... -- Computerization -- Statistical Advances -- A Likely Future -- Final Comments -- Key Facts -- Cross-References -- References -- 3 Terminology: Conventions and Recommendations -- Introduction -- Clinical Trial -- Trial Versus Study -- Pilot Study Versus Feasibility Study -- Name of Trial -- Name of the Experimental Variable: Treatment Versus Intervention -- Name for Groups Represented by Experimental Variable: Study Group, Treatment Group, or Arm -- Persons Studied: Subject, Patient, or Participant -- Trial Protocol Versus Manual of Operations -- Blocking Versus Stratification and Quotafication -- Open -- Controlled -- Placebo -- Consent -- Randomization Versus Randomized -- Registration Versus Enrollment.
Single Center Trial Versus Multicenter Trial -- Multicenter Versus Cooperative Versus Collaborative -- Principal Investigator (PI) Versus Study Chair -- Clinical Investigator Versus Investigator -- Steering Committee Versus Executive Committee -- Data Monitoring Versus Data Monitoring Committee -- Random Versus Haphazard -- Primary Versus Secondary Outcomes -- Outcome Versus Endpoint -- Treatment Failure Versus Treatment Cessation -- Blind Versus Mask -- Lost to Followup -- Dropout -- Withdrawals -- Design Variable Versus Primary Outcome Measure -- Baseline Versus Baseline Period -- Screened Versus Enrolled -- End of Followup Versus End of Trial -- Analysis by Assigned Treatment Versus Per Protocol Analysis -- Bias -- Early Stop Versus Nominal Stop -- Summary -- References -- 4 Clinical Trials, Ethics, and Human Protections Policies -- Origins of Research Ethics -- Conception of Trials -- Design of Trials -- Risk/Benefit -- Justification of Therapeutic Procedures: Clinical Equipoise -- Justification of Demarcated Research Procedures -- Riskless Research, High Risk Research, Comparative Effectiveness Trials, and Ethics -- Maximizing Efficiencies -- Justice -- Fair Subject Selection -- Inclusion -- Trial Inception -- Respect for Persons -- Elements of Valid Informed Consent -- Research Without Informed Consent -- Informed Consent Documents -- Independent Review -- Conduct -- Trials and Ethics Across Time -- Reporting -- Publication and Results Deposition -- Methods and Outcome Reporting -- The Afterlife of Trials -- Synthesis -- Cross-References -- References -- 5 History of the Society for Clinical Trials -- Introduction -- Background: 1967-1972 -- Steps in the Creation of the Society for Clinical Trials -- Meetings of Coordinating Center Personnel -- Coordinating Center Models Project -- National Conference on Clinical Trials Methodology. Journals of the Society for Clinical Trials -- International Participation -- Summary and Conclusion -- References -- Part II: Conduct and Management -- 6 Investigator Responsibilities -- Introduction -- Definitions -- Research -- Investigators -- Overall Responsibilities of Investigators -- Research Study Design and Conduct -- Design -- Conduct -- Qualifications, Training, and Delegation of Tasks -- The Clinical Research Team -- Accountability of Investigational Agents -- Data Collection, Research Record Maintenance, and Retention -- Reporting of Research Findings -- Safeguards to Protect Research Participants -- Adverse Event Reporting -- Safety Oversight -- IRB Requirements -- Informed Consent Process -- Protocol Noncompliance and Research Misconduct -- Protocol Noncompliance -- Research Misconduct -- Summary and Conclusion -- Key Facts -- Regulations and Policies -- Cross-References -- References -- 7 Centers Participating in Multicenter Trials -- Introduction -- Roles and Functions of Resource Centers -- Coordinating Centers -- Clinical Coordinating Centers -- Data Coordinating Centers -- Other Resource Centers -- Clinical Centers -- The Implementation Phase -- Organizing the Site -- Assembling the Study Team -- Attributes of the Principal Investigator -- Attributes of the Clinical Coordinator -- Interactions with the Team -- Ethical Approval -- Organization Binders/Files -- Certification and Training -- Participant Enrollment Phase -- Recruitment -- Screening and Randomization -- Treatment and Follow-Up Phase -- Scheduling and Communications -- Adverse Events -- Data Collection -- Data Management -- Site Visits -- Study Meetings -- Participant Closeout Phase -- Final Follow-Up Visit -- Post-Funding Phase -- Dissemination of Study Results -- Summary and Conclusion -- Key Facts -- Cross-References -- References. 8 Qualifications of the Research Staff -- Introduction -- History of Clinical Research Staff -- Staff Qualifications -- Training -- Credentialing Organizations in Clinical Research -- Summary -- Key Facts -- Cross-References -- References -- 9 Multicenter and Network Trials -- Introduction -- Multicenter Clinical Trials -- Formation -- Trial Leadership -- Design Considerations -- Coordination of Study Activities and Logistics Between Sites -- Clinical Trial Networks -- Summary and Conclusions -- Key Facts -- Cross-References -- References -- 10 Principles of Protocol Development -- Introduction -- Administrative Information: SPIRIT Checklist Items 1-5d -- Background and Rationale and Objectives: SPIRIT Checklist Items 6-7 -- Trial Design: SPIRIT Checklist Item 8 -- Participants, Interventions, and Outcomes: SPIRIT Checklist Items 9-17b -- Participants -- Interventions -- Outcomes -- Participant Timeline, Sample Size Recruitment (Items 13-15) -- Sample Size -- Recruitment -- Assignment of Interventions (for Controlled Trials): Spirit Checklist Items 16-17b -- Data Collection/Management and Analysis: SPIRIT Checklist Items 18a-20c -- Data Collection -- Data Management -- Statistical Analysis -- Monitoring: SPIRIT Checklist Items 21-23 -- Data Monitoring -- Efficacy -- Harm -- Quality Assurance (Monitoring/Auditing) -- Ethics and Dissemination: SPIRIT Checklist Items 24-31c -- Ethics -- Dissemination -- Conclusion -- References -- 11 Procurement and Distribution of Study Medicines -- Introduction -- Procurement of Investigational Product -- Investigational Product Procurement Planning -- Use of a Generic Drug -- Considerations for IP Procurement/Manipulation in Blinded Trials -- Impact of IP-Related Factors: Controlled Substances -- Identification of Qualified Vendors -- Packaging Considerations. Manufacturing and Packaging Considerations for Blinded Trials -- International Clinical Trials -- Distribution of Investigational Product -- Documents to Support Release of IP to Qualified Sites -- Use of Controlled Substances in Clinical Trials -- IP Inventory Management for Complex Study Designs -- IP Accountability -- Shipping and Receipt of IP -- Quality Assurance -- Summary and Conclusion -- Key Facts -- References -- 12 Selection of Study Centers and Investigators -- Introduction -- Site and Investigator Selection Plan -- Site Selection -- Facility Resources -- Site and Process Flow -- Administrative Considerations -- Recruitment Potential -- Regulatory and Ethics Requirements -- Investigator Selection -- Investigator Responsibilities -- Investigator Qualification -- Investigative Team Considerations -- Investigator Equipoise -- Investigator Motivation -- Site Team Dynamics -- Research Experience and Past Performance -- Site and Investigator Selection Methods -- Surveys and Questionnaires -- Site Qualification Visit -- Summary -- Key Facts -- References -- 13 Design and Development of the Study Data System -- Introduction -- Descriptive Overview -- System Components: The Naming of Parts -- The Rise of the eRDC Workflow -- Deployment Options and Implications -- Constructing the Study Definition -- Overview -- Working from the Protocol -- Working Up the Functional Specification -- ``User Acceptance Testing´´ -- Final Approval of the Specification -- Using Data Standards -- Validating the Specification and Final Release -- Development and Testing Environments -- The Study Data System in the Longer Term -- Change Management -- Exporting the Data for Analysis -- Summary and Conclusion -- Key Facts -- Cross-References -- References -- 14 Implementing the Trial Protocol -- Introduction -- Protocol Development -- Site Selection, Feasibility, and Set Up. Site Characteristics. |
| Record Nr. | UNINA-9910585772403321 |
| Cham, Switzerland : , : Springer, , [2022] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Principles and practice of clinical trials / / edited by Steven Piantadosi and Curtis L. Meinert
| Principles and practice of clinical trials / / edited by Steven Piantadosi and Curtis L. Meinert |
| Pubbl/distr/stampa | Cham, Switzerland : , : Springer, , [2022] |
| Descrizione fisica | 1 online resource (2573 pages) : illustrations (some color) |
| Disciplina | 610.727 |
| Soggetto topico |
Clinical trials
Statistics Clinical trials - Statistical methods Assaigs clínics |
| Soggetto genere / forma | Llibres electrònics |
| ISBN | 3-319-52636-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Intro -- A Foreword to the Principles and Practice of Clinical Trials -- Preface -- Acknowledgments -- Contents -- About the Editors -- About the Section Editors -- Contributors -- Part I: Perspectives on Clinical Trials -- 1 Social and Scientific History of Randomized Controlled Trials -- Introduction -- Early History of Clinical Trials -- Refining Trial Methods in the Early Twentieth Century -- The Role of Governments in the Institutionalization of Randomized Controlled Trials -- Historical Trial Ethics -- RCTs and Evidence-Based Medicine -- The Globalization of RCTs and the Challenges of Similarities and Differences in Global Populations -- Social and Scientific Challenges in Randomized Controlled Trials -- Summary and Conclusion -- Key Facts -- Cross-References -- References -- 2 Evolution of Clinical Trials Science -- Introduction -- The Scientific MethodScience is the study of natural phenomena, which are accessible to both passive and active observation. P... -- Some Key Evolutionary Developments -- Ethics -- Governance ModelsRunning a clinical trial in the modern world is not simple and requires some unique governance features. Whil... -- Computerization -- Statistical Advances -- A Likely Future -- Final Comments -- Key Facts -- Cross-References -- References -- 3 Terminology: Conventions and Recommendations -- Introduction -- Clinical Trial -- Trial Versus Study -- Pilot Study Versus Feasibility Study -- Name of Trial -- Name of the Experimental Variable: Treatment Versus Intervention -- Name for Groups Represented by Experimental Variable: Study Group, Treatment Group, or Arm -- Persons Studied: Subject, Patient, or Participant -- Trial Protocol Versus Manual of Operations -- Blocking Versus Stratification and Quotafication -- Open -- Controlled -- Placebo -- Consent -- Randomization Versus Randomized -- Registration Versus Enrollment.
Single Center Trial Versus Multicenter Trial -- Multicenter Versus Cooperative Versus Collaborative -- Principal Investigator (PI) Versus Study Chair -- Clinical Investigator Versus Investigator -- Steering Committee Versus Executive Committee -- Data Monitoring Versus Data Monitoring Committee -- Random Versus Haphazard -- Primary Versus Secondary Outcomes -- Outcome Versus Endpoint -- Treatment Failure Versus Treatment Cessation -- Blind Versus Mask -- Lost to Followup -- Dropout -- Withdrawals -- Design Variable Versus Primary Outcome Measure -- Baseline Versus Baseline Period -- Screened Versus Enrolled -- End of Followup Versus End of Trial -- Analysis by Assigned Treatment Versus Per Protocol Analysis -- Bias -- Early Stop Versus Nominal Stop -- Summary -- References -- 4 Clinical Trials, Ethics, and Human Protections Policies -- Origins of Research Ethics -- Conception of Trials -- Design of Trials -- Risk/Benefit -- Justification of Therapeutic Procedures: Clinical Equipoise -- Justification of Demarcated Research Procedures -- Riskless Research, High Risk Research, Comparative Effectiveness Trials, and Ethics -- Maximizing Efficiencies -- Justice -- Fair Subject Selection -- Inclusion -- Trial Inception -- Respect for Persons -- Elements of Valid Informed Consent -- Research Without Informed Consent -- Informed Consent Documents -- Independent Review -- Conduct -- Trials and Ethics Across Time -- Reporting -- Publication and Results Deposition -- Methods and Outcome Reporting -- The Afterlife of Trials -- Synthesis -- Cross-References -- References -- 5 History of the Society for Clinical Trials -- Introduction -- Background: 1967-1972 -- Steps in the Creation of the Society for Clinical Trials -- Meetings of Coordinating Center Personnel -- Coordinating Center Models Project -- National Conference on Clinical Trials Methodology. Journals of the Society for Clinical Trials -- International Participation -- Summary and Conclusion -- References -- Part II: Conduct and Management -- 6 Investigator Responsibilities -- Introduction -- Definitions -- Research -- Investigators -- Overall Responsibilities of Investigators -- Research Study Design and Conduct -- Design -- Conduct -- Qualifications, Training, and Delegation of Tasks -- The Clinical Research Team -- Accountability of Investigational Agents -- Data Collection, Research Record Maintenance, and Retention -- Reporting of Research Findings -- Safeguards to Protect Research Participants -- Adverse Event Reporting -- Safety Oversight -- IRB Requirements -- Informed Consent Process -- Protocol Noncompliance and Research Misconduct -- Protocol Noncompliance -- Research Misconduct -- Summary and Conclusion -- Key Facts -- Regulations and Policies -- Cross-References -- References -- 7 Centers Participating in Multicenter Trials -- Introduction -- Roles and Functions of Resource Centers -- Coordinating Centers -- Clinical Coordinating Centers -- Data Coordinating Centers -- Other Resource Centers -- Clinical Centers -- The Implementation Phase -- Organizing the Site -- Assembling the Study Team -- Attributes of the Principal Investigator -- Attributes of the Clinical Coordinator -- Interactions with the Team -- Ethical Approval -- Organization Binders/Files -- Certification and Training -- Participant Enrollment Phase -- Recruitment -- Screening and Randomization -- Treatment and Follow-Up Phase -- Scheduling and Communications -- Adverse Events -- Data Collection -- Data Management -- Site Visits -- Study Meetings -- Participant Closeout Phase -- Final Follow-Up Visit -- Post-Funding Phase -- Dissemination of Study Results -- Summary and Conclusion -- Key Facts -- Cross-References -- References. 8 Qualifications of the Research Staff -- Introduction -- History of Clinical Research Staff -- Staff Qualifications -- Training -- Credentialing Organizations in Clinical Research -- Summary -- Key Facts -- Cross-References -- References -- 9 Multicenter and Network Trials -- Introduction -- Multicenter Clinical Trials -- Formation -- Trial Leadership -- Design Considerations -- Coordination of Study Activities and Logistics Between Sites -- Clinical Trial Networks -- Summary and Conclusions -- Key Facts -- Cross-References -- References -- 10 Principles of Protocol Development -- Introduction -- Administrative Information: SPIRIT Checklist Items 1-5d -- Background and Rationale and Objectives: SPIRIT Checklist Items 6-7 -- Trial Design: SPIRIT Checklist Item 8 -- Participants, Interventions, and Outcomes: SPIRIT Checklist Items 9-17b -- Participants -- Interventions -- Outcomes -- Participant Timeline, Sample Size Recruitment (Items 13-15) -- Sample Size -- Recruitment -- Assignment of Interventions (for Controlled Trials): Spirit Checklist Items 16-17b -- Data Collection/Management and Analysis: SPIRIT Checklist Items 18a-20c -- Data Collection -- Data Management -- Statistical Analysis -- Monitoring: SPIRIT Checklist Items 21-23 -- Data Monitoring -- Efficacy -- Harm -- Quality Assurance (Monitoring/Auditing) -- Ethics and Dissemination: SPIRIT Checklist Items 24-31c -- Ethics -- Dissemination -- Conclusion -- References -- 11 Procurement and Distribution of Study Medicines -- Introduction -- Procurement of Investigational Product -- Investigational Product Procurement Planning -- Use of a Generic Drug -- Considerations for IP Procurement/Manipulation in Blinded Trials -- Impact of IP-Related Factors: Controlled Substances -- Identification of Qualified Vendors -- Packaging Considerations. Manufacturing and Packaging Considerations for Blinded Trials -- International Clinical Trials -- Distribution of Investigational Product -- Documents to Support Release of IP to Qualified Sites -- Use of Controlled Substances in Clinical Trials -- IP Inventory Management for Complex Study Designs -- IP Accountability -- Shipping and Receipt of IP -- Quality Assurance -- Summary and Conclusion -- Key Facts -- References -- 12 Selection of Study Centers and Investigators -- Introduction -- Site and Investigator Selection Plan -- Site Selection -- Facility Resources -- Site and Process Flow -- Administrative Considerations -- Recruitment Potential -- Regulatory and Ethics Requirements -- Investigator Selection -- Investigator Responsibilities -- Investigator Qualification -- Investigative Team Considerations -- Investigator Equipoise -- Investigator Motivation -- Site Team Dynamics -- Research Experience and Past Performance -- Site and Investigator Selection Methods -- Surveys and Questionnaires -- Site Qualification Visit -- Summary -- Key Facts -- References -- 13 Design and Development of the Study Data System -- Introduction -- Descriptive Overview -- System Components: The Naming of Parts -- The Rise of the eRDC Workflow -- Deployment Options and Implications -- Constructing the Study Definition -- Overview -- Working from the Protocol -- Working Up the Functional Specification -- ``User Acceptance Testing´´ -- Final Approval of the Specification -- Using Data Standards -- Validating the Specification and Final Release -- Development and Testing Environments -- The Study Data System in the Longer Term -- Change Management -- Exporting the Data for Analysis -- Summary and Conclusion -- Key Facts -- Cross-References -- References -- 14 Implementing the Trial Protocol -- Introduction -- Protocol Development -- Site Selection, Feasibility, and Set Up. Site Characteristics. |
| Record Nr. | UNISA-996483154503316 |
| Cham, Switzerland : , : Springer, , [2022] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. di Salerno | ||
| ||
Real-World Evidence in Medical Product Development / / edited by Weili He, Yixin Fang, Hongwei Wang
| Real-World Evidence in Medical Product Development / / edited by Weili He, Yixin Fang, Hongwei Wang |
| Edizione | [1st ed. 2023.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Springer, , 2023 |
| Descrizione fisica | 1 online resource (431 pages) |
| Disciplina | 615.19 |
| Soggetto topico |
Statistics
Artificial intelligence—Data processing Computer science—Mathematics Data Science Mathematics of Computing Desenvolupament de medicaments Assaigs clínics |
| Soggetto genere / forma | Llibres electrònics |
| Soggetto non controllato |
Therapeutics
Medical |
| ISBN | 3-031-26328-6 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Preface -- Part I. Real-World Data and Evidence to Accelerate Medical Product Development -- The need for real world data/evidence in clinical development and life cycle management, and future directions -- Overview of current RWE/RWD landscape -- Key considerations in forming research questions -- Part II. Fit-for-use RWD Assessment and Data Standards -- Assessment of fit-for-use real-world data sources and applications -- Key variables ascertainment and validation in real-world setting -- Data standards and platform interoperability -- Privacy-preserving data linkage for real-world datasets -- Part III. Causal Inference Framework and Methodologies in RWE Research -- Causal Inference with Targeted Learning for Producing and Evaluating Real-World Evidence -- Framework and Examples of Estimands in Real-World Studies -- Clinical Studies Leveraging Real-World Data Using Propensity Score-Based Methods -- Recent statistical development for comparative effectiveness research beyond propensity-score methods -- Innovative Hybrid Designs and Analytical Approaches leveraging Real-Word Data and Clinical Trial data -- Statistical challenges for causal inference using time-to-event real-world data -- Sensitivity Analyses for Unmeasured Confounding: This is the way -- Sensitivity analysis in the analysis of real-world data -- Personalized medicine with advanced analytics -- Use of Real-World Evidence in Health Technology Assessment Submissions -- Part IV. Application and Case studies -- Examples of applying causal-inference roadmap to real-world studies -- Applications using real-world evidence to accelerate medical product development -- The use of real-world data to support the assessment of the benefit and risk of a medicine to treat spinal muscular atrophy -- Index. |
| Record Nr. | UNINA-9910726291303321 |
| Cham : , : Springer International Publishing : , : Imprint : Springer, , 2023 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
