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Biblioteca

MARC Lista (tabellare)
Medical statistics from scratch : an introduction for health professionals / / David Bowers
Medical statistics from scratch : an introduction for health professionals / / David Bowers
Autore Bowers David <1938->
Edizione [Fourth edition.]
Pubbl/distr/stampa Hoboken NJ : , : Wiley Blackwell, , 2020
Descrizione fisica 1 online ressurs (498 sider) : illustrasjoner
Disciplina 610.727
Soggetto topico Medical statistics
Biometry
Statistics as Topic
ISBN 1-119-52394-X
1-119-52392-3
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Record Nr. UNINA-9910827302303321
Bowers David <1938->  
Hoboken NJ : , : Wiley Blackwell, , 2020
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Medical statistics from scratch [[electronic resource] ] : an introduction for health professionals / / David Bowers
Medical statistics from scratch [[electronic resource] ] : an introduction for health professionals / / David Bowers
Autore Bowers David <1938->
Edizione [2nd ed.]
Pubbl/distr/stampa Chichester, England ; ; Hoboken, NJ, : John Wiley & Sons, c2008
Descrizione fisica 1 online resource (302 p.)
Disciplina 610.72/7
610.727
Soggetto topico Medical statistics
Medicine - Research - Statistical methods
Soggetto genere / forma Electronic books.
ISBN 1-281-32182-6
9786611321826
0-470-72444-7
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Medical Statistics from Scratch; Contents; Preface to the 2nd Edition; Preface to the 1st Edition; Introduction; I Some Fundamental Stuff; 1 First things first - the nature of data; Learning Objectives; Variables and Data; The good, the Bad, and the Ugly - Types of Variable; Categorical Variables; Metric Variables; How can I Tell what Type of Variable I am Dealing with?; II Descriptive Statistics; 2 Describing Data with Tables; Learning Objectives; What is Descriptive Statistics?; The Frequency Table; 3 Describing Data with Charts; Learning Objectives; Picture it!
Charting Nominal and Ordinal DataCharting Discrete Metric Data; Charting Continuous Metric Data; Charting Cumulative Data; 4 Describing Data from its Shape; Learning Objectives; The Shape of Things to Come; 5 Describing Data with Numeric Summary Values; Learning Objectives; Numbers R us; Summary Measures of Location; Summary Measures of Spread; Standard Deviation and the Normal Distribution; III Getting the Data; 6 Doing it Right First Time - Designing a Study; Learning Objectives; Hey ho! Hey ho! It's Off to Work we Go; Collecting the Data - Types of Sample; Types of Study; Confounding
MatchingComparing Cohort and Case-Control Designs; Getting Stuck in - Experimental Studies; IV From Little to Large - Statistical Inference; 7 From Samples to Populations - Making Inferences; Learning Objectives; Statistical Inference; 8 Probability, Risk and Odds; Learning Objectives; Chance would be a Fine Thing - The Idea of Probability; Calculating Probability; Probability and the Normal Distribution; Risk; Odds; Why you can't Calculate Risk in a Case-Control Study; The Link between Probability and Odds; The Risk Ratio; The Odds Ratio; Number Needed to Treat (NNT)
V The Informed Guess - Confidence Interval Estimation9 Estimating the Value of a Single Population Parameter - The Idea of Confidence Intervals; Learning Objectives; Confidence Interval Estimation for a Population Mean; Confidence Interval for a Population Proportion; Estimating a Confidence Interval for the Median of a Single Population; 10 Estimating the Difference between Two Population Parameters; Learning Objectives; What's the Difference?; Estimating the Difference between the Means of Two Independent Populations - Using a Method Based on the Two-Sample t Test
Estimating the Difference between Two Matched Population Means - Using a Method Based on the Matched-Pairs t TestEstimating the Difference between Two Independent Population Proportions; Estimating the Difference between Two Independent Population Medians - The Mann-Whitney Rank-Sums Method; Estimating the Difference between Two Matched Population Medians - Wilcoxon Signed-Ranks Method; 11 Estimating the Ratio of Two Population Parameters; Learning Objectives; Estimating Ratios of Means, Risks and Odds; VI Putting it to the Test
12 Testing Hypotheses about the Difference between Two Population Parameters
Record Nr. UNINA-9910458277203321
Bowers David <1938->  
Chichester, England ; ; Hoboken, NJ, : John Wiley & Sons, c2008
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Medical statistics made easy / / Michael Harris and Gordon Taylor
Medical statistics made easy / / Michael Harris and Gordon Taylor
Autore Harris Michael
Edizione [Third edition.]
Pubbl/distr/stampa Banbury, England : , : Scion, , 2014
Descrizione fisica 1 online resource (xii, 116 pages) : illustrations
Disciplina 610.727
Soggetto topico Medical statistics
Biometry
ISBN 1-907904-03-4
1-907904-45-X
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Altri titoli varianti Medical statistics made easy 3
Record Nr. UNINA-9910159402503321
Harris Michael  
Banbury, England : , : Scion, , 2014
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Meta analysis [[electronic resource] ] : a guide to calibrating and combining statistical evidence / / Elena Kulinskaya, Stephan Morgenthaler, Robert G. Staudte
Meta analysis [[electronic resource] ] : a guide to calibrating and combining statistical evidence / / Elena Kulinskaya, Stephan Morgenthaler, Robert G. Staudte
Autore Kulinskaya Elena
Pubbl/distr/stampa Chichester, West Sussex ; ; Hoboken, NJ, : John Wiley & Sons, c2008
Descrizione fisica 1 online resource (284 p.)
Disciplina 519.5
610.72/7
610.727
Altri autori (Persone) MorgenthalerStephan
StaudteRobert G
Collana Wiley series in probability and statistics
Soggetto topico Meta-analysis
Medicine - Research - Evaluation
Soggetto genere / forma Electronic books.
ISBN 1-281-31981-3
9786611319816
0-470-98553-4
0-470-98552-6
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Meta Analysis A Guide to Calibrating and Combining Statistical Evidence; Contents; Preface; Part I The Methods; 1 What can the reader expect from this book?; 1.1 A calibration scale for evidence; 1.1.1 T -values and p-values; 1.1.2 How generally applicable is the calibration scale?; 1.1.3 Combining evidence; 1.2 The efficacy of glass ionomer versus resin sealants for prevention of caries; 1.2.1 The data; 1.2.2 Analysis for individual studies; 1.2.3 Combining the evidence: fixed effects model; 1.2.4 Combining the evidence: random effects model; 1.3 Measures of effect size for two populations
1.4 Summary2 Independent measurements with known precision; 2.1 Evidence for one-sided alternatives; 2.2 Evidence for two-sided alternatives; 2.3 Examples; 2.3.1 Filling containers; 2.3.2 Stability of blood samples; 2.3.3 Blood alcohol testing; 3 Independent measurements with unknown precision; 3.1 Effects and standardized effects; 3.2 Paired comparisons; 3.3 Examples; 3.3.1 Daily energy intake compared to a fixed level; 3.3.2 Darwin's data on Zea mays; 4 Comparing treatment to control; 4.1 Equal unknown precision; 4.2 Differing unknown precision; 4.3 Examples
4.3.1 Drop in systolic blood pressure4.3.2 Effect of psychotherapy on hospital length of stay; 5 Comparing K treatments; 5.1 Methodology; 5.2 Examples; 5.2.1 Characteristics of antibiotics; 5.2.2 Red cell folate levels; 6 Evaluating risks; 6.1 Methodology; 6.2 Examples; 6.2.1 Ultrasound and left-handedness; 6.2.2 Treatment of recurrent urinary tract infections; 7 Comparing risks; 7.1 Methodology; 7.2 Examples; 7.2.1 Treatment of recurrent urinary tract infections; 7.2.2 Diuretics in pregnancy and risk of pre-eclamsia; 8 Evaluating Poisson rates; 8.1 Methodology; 8.2 Example
8.2.1 Deaths by horse-kicks9 Comparing Poisson rates; 9.1 Methodology; 9.1.1 Unconditional evidence; 9.1.2 Conditional evidence; 9.2 Example; 9.2.1 Vaccination for the prevention of tuberculosis; 10 Goodness-of-fit testing; 10.1 Methodology; 10.2 Example; 10.2.1 Bellbirds arriving to feed nestlings; 11 Evidence for heterogeneity of effects and transformed effects; 11.1 Methodology; 11.1.1 Fixed effects; 11.1.2 Random effects; 11.2 Examples; 11.2.1 Deaths by horse-kicks; 11.2.2 Drop in systolic blood pressure; 11.2.3 Effect of psychotherapy on hospital length of stay
11.2.4 Diuretics in pregnancy and risk of pre-eclamsia12 Combining evidence: fixed standardized effects model; 12.1 Methodology; 12.2 Examples; 12.2.1 Deaths by horse-kicks; 12.2.2 Drop in systolic blood pressure; 13 Combining evidence: random standardized effects model; 13.1 Methodology; 13.2 Example; 13.2.1 Diuretics in pregnancy and risk of pre-eclamsia; 14 Meta-regression; 14.1 Methodology; 14.2 Commonly encountered situations; 14.2.1 Standardized difference of means; 14.2.2 Difference in risk (two binomial proportions); 14.2.3 Log relative risk (two Poisson rates); 14.3 Examples
14.3.1 Effect of open education on student creativity
Record Nr. UNINA-9910145747103321
Kulinskaya Elena  
Chichester, West Sussex ; ; Hoboken, NJ, : John Wiley & Sons, c2008
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Meta analysis [[electronic resource] ] : a guide to calibrating and combining statistical evidence / / Elena Kulinskaya, Stephan Morgenthaler, Robert G. Staudte
Meta analysis [[electronic resource] ] : a guide to calibrating and combining statistical evidence / / Elena Kulinskaya, Stephan Morgenthaler, Robert G. Staudte
Autore Kulinskaya Elena
Pubbl/distr/stampa Chichester, West Sussex ; ; Hoboken, NJ, : John Wiley & Sons, c2008
Descrizione fisica 1 online resource (284 p.)
Disciplina 519.5
610.72/7
610.727
Altri autori (Persone) MorgenthalerStephan
StaudteRobert G
Collana Wiley series in probability and statistics
Soggetto topico Meta-analysis
Medicine - Research - Evaluation
ISBN 1-281-31981-3
9786611319816
0-470-98553-4
0-470-98552-6
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Meta Analysis A Guide to Calibrating and Combining Statistical Evidence; Contents; Preface; Part I The Methods; 1 What can the reader expect from this book?; 1.1 A calibration scale for evidence; 1.1.1 T -values and p-values; 1.1.2 How generally applicable is the calibration scale?; 1.1.3 Combining evidence; 1.2 The efficacy of glass ionomer versus resin sealants for prevention of caries; 1.2.1 The data; 1.2.2 Analysis for individual studies; 1.2.3 Combining the evidence: fixed effects model; 1.2.4 Combining the evidence: random effects model; 1.3 Measures of effect size for two populations
1.4 Summary2 Independent measurements with known precision; 2.1 Evidence for one-sided alternatives; 2.2 Evidence for two-sided alternatives; 2.3 Examples; 2.3.1 Filling containers; 2.3.2 Stability of blood samples; 2.3.3 Blood alcohol testing; 3 Independent measurements with unknown precision; 3.1 Effects and standardized effects; 3.2 Paired comparisons; 3.3 Examples; 3.3.1 Daily energy intake compared to a fixed level; 3.3.2 Darwin's data on Zea mays; 4 Comparing treatment to control; 4.1 Equal unknown precision; 4.2 Differing unknown precision; 4.3 Examples
4.3.1 Drop in systolic blood pressure4.3.2 Effect of psychotherapy on hospital length of stay; 5 Comparing K treatments; 5.1 Methodology; 5.2 Examples; 5.2.1 Characteristics of antibiotics; 5.2.2 Red cell folate levels; 6 Evaluating risks; 6.1 Methodology; 6.2 Examples; 6.2.1 Ultrasound and left-handedness; 6.2.2 Treatment of recurrent urinary tract infections; 7 Comparing risks; 7.1 Methodology; 7.2 Examples; 7.2.1 Treatment of recurrent urinary tract infections; 7.2.2 Diuretics in pregnancy and risk of pre-eclamsia; 8 Evaluating Poisson rates; 8.1 Methodology; 8.2 Example
8.2.1 Deaths by horse-kicks9 Comparing Poisson rates; 9.1 Methodology; 9.1.1 Unconditional evidence; 9.1.2 Conditional evidence; 9.2 Example; 9.2.1 Vaccination for the prevention of tuberculosis; 10 Goodness-of-fit testing; 10.1 Methodology; 10.2 Example; 10.2.1 Bellbirds arriving to feed nestlings; 11 Evidence for heterogeneity of effects and transformed effects; 11.1 Methodology; 11.1.1 Fixed effects; 11.1.2 Random effects; 11.2 Examples; 11.2.1 Deaths by horse-kicks; 11.2.2 Drop in systolic blood pressure; 11.2.3 Effect of psychotherapy on hospital length of stay
11.2.4 Diuretics in pregnancy and risk of pre-eclamsia12 Combining evidence: fixed standardized effects model; 12.1 Methodology; 12.2 Examples; 12.2.1 Deaths by horse-kicks; 12.2.2 Drop in systolic blood pressure; 13 Combining evidence: random standardized effects model; 13.1 Methodology; 13.2 Example; 13.2.1 Diuretics in pregnancy and risk of pre-eclamsia; 14 Meta-regression; 14.1 Methodology; 14.2 Commonly encountered situations; 14.2.1 Standardized difference of means; 14.2.2 Difference in risk (two binomial proportions); 14.2.3 Log relative risk (two Poisson rates); 14.3 Examples
14.3.1 Effect of open education on student creativity
Record Nr. UNINA-9910830214503321
Kulinskaya Elena  
Chichester, West Sussex ; ; Hoboken, NJ, : John Wiley & Sons, c2008
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Meta analysis [[electronic resource] ] : a guide to calibrating and combining statistical evidence / / Elena Kulinskaya, Stephan Morgenthaler, Robert G. Staudte
Meta analysis [[electronic resource] ] : a guide to calibrating and combining statistical evidence / / Elena Kulinskaya, Stephan Morgenthaler, Robert G. Staudte
Autore Kulinskaya Elena
Pubbl/distr/stampa Chichester, West Sussex ; ; Hoboken, NJ, : John Wiley & Sons, c2008
Descrizione fisica 1 online resource (284 p.)
Disciplina 519.5
610.72/7
610.727
Altri autori (Persone) MorgenthalerStephan
StaudteRobert G
Collana Wiley series in probability and statistics
Soggetto topico Meta-analysis
Medicine - Research - Evaluation
ISBN 1-281-31981-3
9786611319816
0-470-98553-4
0-470-98552-6
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Meta Analysis A Guide to Calibrating and Combining Statistical Evidence; Contents; Preface; Part I The Methods; 1 What can the reader expect from this book?; 1.1 A calibration scale for evidence; 1.1.1 T -values and p-values; 1.1.2 How generally applicable is the calibration scale?; 1.1.3 Combining evidence; 1.2 The efficacy of glass ionomer versus resin sealants for prevention of caries; 1.2.1 The data; 1.2.2 Analysis for individual studies; 1.2.3 Combining the evidence: fixed effects model; 1.2.4 Combining the evidence: random effects model; 1.3 Measures of effect size for two populations
1.4 Summary2 Independent measurements with known precision; 2.1 Evidence for one-sided alternatives; 2.2 Evidence for two-sided alternatives; 2.3 Examples; 2.3.1 Filling containers; 2.3.2 Stability of blood samples; 2.3.3 Blood alcohol testing; 3 Independent measurements with unknown precision; 3.1 Effects and standardized effects; 3.2 Paired comparisons; 3.3 Examples; 3.3.1 Daily energy intake compared to a fixed level; 3.3.2 Darwin's data on Zea mays; 4 Comparing treatment to control; 4.1 Equal unknown precision; 4.2 Differing unknown precision; 4.3 Examples
4.3.1 Drop in systolic blood pressure4.3.2 Effect of psychotherapy on hospital length of stay; 5 Comparing K treatments; 5.1 Methodology; 5.2 Examples; 5.2.1 Characteristics of antibiotics; 5.2.2 Red cell folate levels; 6 Evaluating risks; 6.1 Methodology; 6.2 Examples; 6.2.1 Ultrasound and left-handedness; 6.2.2 Treatment of recurrent urinary tract infections; 7 Comparing risks; 7.1 Methodology; 7.2 Examples; 7.2.1 Treatment of recurrent urinary tract infections; 7.2.2 Diuretics in pregnancy and risk of pre-eclamsia; 8 Evaluating Poisson rates; 8.1 Methodology; 8.2 Example
8.2.1 Deaths by horse-kicks9 Comparing Poisson rates; 9.1 Methodology; 9.1.1 Unconditional evidence; 9.1.2 Conditional evidence; 9.2 Example; 9.2.1 Vaccination for the prevention of tuberculosis; 10 Goodness-of-fit testing; 10.1 Methodology; 10.2 Example; 10.2.1 Bellbirds arriving to feed nestlings; 11 Evidence for heterogeneity of effects and transformed effects; 11.1 Methodology; 11.1.1 Fixed effects; 11.1.2 Random effects; 11.2 Examples; 11.2.1 Deaths by horse-kicks; 11.2.2 Drop in systolic blood pressure; 11.2.3 Effect of psychotherapy on hospital length of stay
11.2.4 Diuretics in pregnancy and risk of pre-eclamsia12 Combining evidence: fixed standardized effects model; 12.1 Methodology; 12.2 Examples; 12.2.1 Deaths by horse-kicks; 12.2.2 Drop in systolic blood pressure; 13 Combining evidence: random standardized effects model; 13.1 Methodology; 13.2 Example; 13.2.1 Diuretics in pregnancy and risk of pre-eclamsia; 14 Meta-regression; 14.1 Methodology; 14.2 Commonly encountered situations; 14.2.1 Standardized difference of means; 14.2.2 Difference in risk (two binomial proportions); 14.2.3 Log relative risk (two Poisson rates); 14.3 Examples
14.3.1 Effect of open education on student creativity
Record Nr. UNINA-9910841737803321
Kulinskaya Elena  
Chichester, West Sussex ; ; Hoboken, NJ, : John Wiley & Sons, c2008
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Open access medical statistics
Open access medical statistics
Pubbl/distr/stampa [Auckland, N.Z.] : , : Dovepress, , 2011-
Disciplina 610.727
Soggetto topico Medical statistics
Medicine - statistics & numerical data
Statistics as Topic
Soggetto genere / forma Periodical
Periodicals.
Formato Materiale a stampa
Livello bibliografico Periodico
Lingua di pubblicazione eng
Altri titoli varianti Journal of open access medical statistics
OAMS
Record Nr. UNISA-996335905103316
[Auckland, N.Z.] : , : Dovepress, , 2011-
Materiale a stampa
Lo trovi qui: Univ. di Salerno
Opac: Controlla la disponibilità qui
Open access medical statistics
Open access medical statistics
Pubbl/distr/stampa [Auckland, N.Z.] : , : Dovepress, , 2011-
Disciplina 610.727
Soggetto topico Medical statistics
Medicine - statistics & numerical data
Statistics as Topic
Soggetto genere / forma Periodical
Periodicals.
Formato Materiale a stampa
Livello bibliografico Periodico
Lingua di pubblicazione eng
Altri titoli varianti Journal of open access medical statistics
OAMS
Record Nr. UNINA-9910141346203321
[Auckland, N.Z.] : , : Dovepress, , 2011-
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Optimization of Behavioral, Biobehavioral, and Biomedical Interventions [[electronic resource] ] : The Multiphase Optimization Strategy (MOST) / / by Linda M. Collins
Optimization of Behavioral, Biobehavioral, and Biomedical Interventions [[electronic resource] ] : The Multiphase Optimization Strategy (MOST) / / by Linda M. Collins
Autore Collins Linda M
Edizione [1st ed. 2018.]
Pubbl/distr/stampa Cham : , : Springer International Publishing : , : Imprint : Springer, , 2018
Descrizione fisica 1 online resource (296 pages) : illustrations, tables
Disciplina 610.727
Collana Statistics for Social and Behavioral Sciences
Soggetto topico Statistics 
Behavioral sciences
Psychology—Methodology
Psychological measurement
Statistics for Social Sciences, Humanities, Law
Behavioral Sciences
Psychological Methods/Evaluation
ISBN 3-319-72206-9
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto 1 Conceptual Introduction to the Multiphase Optimization Strategy (MOST) --  2 The Preparation Phase of MOST -- 3 Introduction to the Factorial Optimization Trial --  4 Interactions Between Components and Moderation of Component Effects --  5 Balanced and Unbalanced Reduced Factorial Designs -- 6  Gathering Information for Decision-Making in the Optimization Phase: Resource Management and Practical Issues --  7 The Completion of the Optimization Phase --  8 Introduction to Adaptive Intervention.
Record Nr. UNINA-9910300122703321
Collins Linda M  
Cham : , : Springer International Publishing : , : Imprint : Springer, , 2018
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
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
Opac: Controlla la disponibilità qui