Fundamentals of clinical research: bridging medicine, statistics and operations
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| Main Authors: | , |
|---|---|
| Format: | Electronic eBook |
| Language: | English Italian |
| Published: |
Milano
Springer
2007
|
| Series: | Statistics for biology and health
|
| Subjects: | |
| Online Access: | Volltext Inhaltsverzeichnis |
| Item Description: | Includes bibliographical references (p. [331]-335) and index |
| Physical Description: | 1 Online-Ressource (XXV, 337 S.) graph. Darst. |
| ISBN: | 9788847004924 |
| DOI: | 10.1007/978-88-470-0492-4 |
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| 245 | 1 | 0 | |a Fundamentals of clinical research |b bridging medicine, statistics and operations |c Antonella Bacchieri ; Giovanni Della Cioppa |
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| adam_text | Contents
Foreword VII
Acknowledgements XI
Contents XIII
Introduction XIX
1. Variability of Biological Phenomena and Measurement Errors 1
1.1. Phenotypic Variability 1
1.2. Temporal Variability 2
1.3. Measurement Related Variability 3
1.3.1. The Measurement 3
1.3.2. Measurement Errors 7
1.4. Variability of Diagnostic Tests 10
Summary 13
2. Distinctive Aspects of a Biomedical Study. Observational
and Experimental Studies 14
2.1. Distinctive Features of Biomedical Studies 14
2.2. The Study Protocol 18
2.3. Observational Studies 21
2.4. Experimental Studies 23
Summary 27
XIV Contents
3. Observational Studies 28
3.1. Basic Designs of Observational Studies 29
3.1.1. Prospective or Cohort Studies 30
3.1.2. Retrospective Studies or Control Cases 36
3.1.3. Sample Size 40
3.2. Bias and Confounding 40
3.2.1. Control of Bias in Epidemiology 44
3.2.2. Control of the Phenomenon of Confounding 49
3.3. Advantages and Disadvantages of the Different Types
of Observational Studies 53
Summary 56
4. Defining the Treatment Effect 58
4.1. From the Single Measurement to the Signal 58
4.2. Identification and Quantification of the End Points
(Individual Subject Level) 64
4.2.1. Methodological Characteristics of the End Point 64
4.2.2 Discriminating between Primary and Secondary
End Points and between Efficacy and Safety/Tolerability
End Points 66
4.3. Identification and Quantification of the Signals (Group Level) . 69
4.4. Statistical Considerations 70
4.5. Practical, Regulatory, Marketing and Pharmaco Economic
Considerations 73
4.6. Selection and Characterization of the Primary End Point
and Signal: an Example 75
4.6.1. Stage One: Define the Main Therapeutic Level 75
4.6.2. Stage Two: Define the Primary End Point
(Individual Patient Level) 77
4.6.3. Stages Three and Four: Define the Group Indicator,
the Signal, and the Threshold of Clinical Relevance
(Treatment Group and Study Levels) 79
4.7. More Than One Question in the Same Study: the Problem
of Multiple Statistical Tests 80
4.8. Validation of Measurement Scales 84
4.9. Special Types of End Points 85
Summary 88
5. Probability, Inference and Decision Making 90
5.1. Probability 91
5.1.1 Definitions 91
5.1.2. Probability Distribution and Probability Density Function 92
5.1.3. Normal or Gaussian Distribution 99
Contents XV
5.2. Basic Concepts of Inference 100
5.2.1. Hypothesis Testing and Statistical Formulation of the
Medical Question 103
5.2.2. Statistical Estimation as the Tool for Evaluation
of Clinical Relevance 105
5.3. Statistical Inference in the Frequentist and the Bayesian
Approaches 106
5.4. Two Digressions: Measures of Variability and Likelihood
Function 110
5.4.1. Measures of Variability 110
5.4.2. Likelihood Function 114
5.5. Frequentist (Classical) Analysis of a Clinical Trial 119
5.5.1. Hypothesis Testing: the Frequentist Solution 120
5.5.2. Estimation of the Effect: the Frequentist Solution 135
5.6. Bayesian Analysis of a Clinical Trial 138
5.6.1. Hypothesis Testing: the Bayesian Solution 138
5.6.2. Estimation of the Effect: the Bayesian Solution 144
5.7. Some Additional Considerations on the Frequentist
and Bayesian Approaches 146
5.8. Parametric and Non Parametric Inference 149
5.9. Statistical Decision Making in the Medical Field 150
5.10. Evidence Based Medicine 152
Summary 154
6. The Choice of the Sample 157
6.1. Which Subjects Should Form the Sample? 157
6.1.1. Characteristics of the Patients to be Enrolled in the Study 157
6.1.2. Mechanism of Subject Selection 163
6.2. How Many Subjects Should Form the Sample? 164
6.2.1. Statistical Considerations 164
6.2.2. Medical and Practical Aspects 169
Summary 171
7. The Choice of Treatments 172
7.1. Study Treatments 172
7.1.1. How Many Treatments 175
7.1.2. What Treatments 176
7.1.3. Blinding of the Study Treatments 178
7.1.4. Packaging and Logistics 178
7.2. Concomitant Treatments 180
Summary 182
XVI Contents
8. Experimental Design: Fallacy of Before After Comparisons
in Uncontrolled Studies 183
8.1. Experimental Design: Introductory Concepts 183
8.2. Before After Comparison in a Single Group of Subjects 185
8.3. Temporal Variations of the Disease 186
8.4. Temporal Variations of Staff, Equipment and Environment.... 188
8.5 Statistical Regression Toward the Mean 189
8.5.1. The Basic Principle 189
8.5.2. Areas of Biomedical Experiments Affected by
Regression Toward the Mean 191
8.5.3. How to Minimize the Effect of Regression Toward
the Mean 193
8.6. Learning Effect 195
8.7. Psychological Effect 196
8.8. The Before After Design Without Control Group in Oncology . . 197
Summary 198
9. Experimental Design: the Randomized Blinded Study
as an Instrument to Reduce Bias 200
9.1. Introduction 200
9.2. Randomization as Antidote Against Selection Bias 203
9.2.1. Definition and Conceptual Framework 203
9.2.2. Types of Randomization 206
9.2.3. Other Methods for Assigning Patients to Treatments .... 215
9.3. Blinding of Treatments as Antidote Against Assessment Bias .. 216
9.4. A Priori Definition of the Statistical Methods and
Populations as Antidote Against the Analysis Bias 221
9.4.1. Methods of Statistical Analysis 221
9.4.2. Analysis Populations 222
9.5. Comparison Between an Observational and an Experimental
Study 224
Summary 227
10. Experiments Designs 228
10.1. Introduction 228
10.2. Parallel Group Design 233
10.2.1. Characteristics 233
10.2.2. Advantages and Disadvantages 233
10.2.3. Conditions of Applicability 234
10.3. Variants of the Parallel Group Design 234
10.3.1. Completely Randomized Parallel Group Design 234
10.3.2. Stratified Parallel Group Design 235
10.3.3. Parallel Group Randomized Block Design 239
10.3.4. Balanced Incomplete Block Design 242
Contents XVII
10.4. Other Designs with Comparison Between Subjects:
Dose Escalation and Dose Titration 244
10.4.1. Dose Escalation Design 244
10.4.2. Dose Titration Design 246
10.5. Complete Cross Over Design 247
10.5.1. Characteristics 247
10.5.2. Advantages and Disadvantages 252
10.5.3. Conditions of Applicability 255
10.6. Variants of the Cross Over Design 256
10.6.1.Variants Based on the Type of Randomization 256
10.6.2. Incomplete Cross Over Designs 257
10.7. Other Designs with Within Subject Comparisons:
Simultaneous Treatments and Single Patient Designs 261
10.7.1. Simultaneous Treatments Design 261
10.7.2. Cross Over Design on a Single Patient
(or N of 1 Design) 261
10.8. Factorial Designs 263
10.8.1. Characteristics 263
10.8.2. Advantages and Disadvantages 268
10.8.3. Conditions of Applicability 270
10.9. Split Plot Design 271
10.9.1. Characteristics 271
10.9.2. Conditions of Applicability 273
10.10. Non Controlled Designs in Phase II Oncology Studies 273
Summary 275
11. Study Variants Applicable to More than One Type of Design:
Equivalence Studies, Interim Analyses, Adaptive Plans
and Repeated Measurements 277
11.1. Equivalence and Non Inferiority Studies 277
11.1.1. Characteristics 277
11.1.2. The Statistical Analysis of an Equivalence Study 280
11.1.3. Planning and Implementation Problems 281
11.1.4. Analysis and Interpretation Problems 285
11.2. Studies with Interim Analyses and Sequential Designs 287
11.2.1. Definitions and Classification 288
11.2.2. Conditions of Applicability 290
11.2.3. Choice of the End Points 292
11.2.4. Data Management Issues 293
11.2.5. Statistical Issues and Decision Making Criteria 294
11.2.6. Conflict of Interest and Confidentiality Issues 298
11.3. Adaptive (Flexible) Designs 299
11.4. Studies with Repeated Measurements 301
Summary 302
XVIII Contents
12.The Drug Development Process and the Phases of Clinical sx
Research 304
12.1. Overview of the Preclinical Development Process 304
12.2. The Phases of Clinical Development 308
12.2.1. Introduction 308
12.2.2. Phase I 309
12.2.3. Phase II 311
12.2.4. Phase III 313
12.2.5. Registration Dossier 315
12.2.6. Phase IV 319
12.2.7. Project Management 321
12.3. The Phases of Clinical Development for Oncology Compounds . 322
12.3.1. Phase I 322
12.3.2. Phase II 323
12.3.3. Phase III 323
12.4. Accelerating Clinical Development 325
Summary 327
Appendix: Areas under the Curve of the Standard Normal Distribution.. . 329
References 331
Analytical Index 337
|
| adam_txt |
Contents
Foreword VII
Acknowledgements XI
Contents XIII
Introduction XIX
1. Variability of Biological Phenomena and Measurement Errors 1
1.1. Phenotypic Variability 1
1.2. Temporal Variability 2
1.3. Measurement Related Variability 3
1.3.1. The Measurement 3
1.3.2. Measurement Errors 7
1.4. Variability of Diagnostic Tests 10
Summary 13
2. Distinctive Aspects of a Biomedical Study. Observational
and Experimental Studies 14
2.1. Distinctive Features of Biomedical Studies 14
2.2. The Study Protocol 18
2.3. Observational Studies 21
2.4. Experimental Studies 23
Summary 27
XIV Contents
3. Observational Studies 28
3.1. Basic Designs of Observational Studies 29
3.1.1. Prospective or Cohort Studies 30
3.1.2. Retrospective Studies or Control Cases 36
3.1.3. Sample Size 40
3.2. Bias and Confounding 40
3.2.1. Control of Bias in Epidemiology 44
3.2.2. Control of the Phenomenon of Confounding 49
3.3. Advantages and Disadvantages of the Different Types
of Observational Studies 53
Summary 56
4. Defining the Treatment Effect 58
4.1. From the Single Measurement to the Signal 58
4.2. Identification and Quantification of the End Points
(Individual Subject Level) 64
4.2.1. Methodological Characteristics of the End Point 64
4.2.2 Discriminating between Primary and Secondary
End Points and between Efficacy and Safety/Tolerability
End Points 66
4.3. Identification and Quantification of the Signals (Group Level) . 69
4.4. Statistical Considerations 70
4.5. Practical, Regulatory, Marketing and Pharmaco Economic
Considerations 73
4.6. Selection and Characterization of the Primary End Point
and Signal: an Example 75
4.6.1. Stage One: Define the Main Therapeutic Level 75
4.6.2. Stage Two: Define the Primary End Point
(Individual Patient Level) 77
4.6.3. Stages Three and Four: Define the Group Indicator,
the Signal, and the Threshold of Clinical Relevance
(Treatment Group and Study Levels) 79
4.7. More Than One Question in the Same Study: the Problem
of Multiple Statistical Tests 80
4.8. Validation of Measurement Scales 84
4.9. Special Types of End Points 85
Summary 88
5. Probability, Inference and Decision Making 90
5.1. Probability 91
5.1.1 Definitions 91
5.1.2. Probability Distribution and Probability Density Function 92
5.1.3. Normal or Gaussian Distribution 99
Contents XV
5.2. Basic Concepts of Inference 100
5.2.1. Hypothesis Testing and Statistical Formulation of the
Medical Question 103
5.2.2. Statistical Estimation as the Tool for Evaluation
of Clinical Relevance 105
5.3. Statistical Inference in the Frequentist and the Bayesian
Approaches 106
5.4. Two Digressions: Measures of Variability and Likelihood
Function 110
5.4.1. Measures of Variability 110
5.4.2. Likelihood Function 114
5.5. Frequentist (Classical) Analysis of a Clinical Trial 119
5.5.1. Hypothesis Testing: the Frequentist Solution 120
5.5.2. Estimation of the Effect: the Frequentist Solution 135
5.6. Bayesian Analysis of a Clinical Trial 138
5.6.1. Hypothesis Testing: the Bayesian Solution 138
5.6.2. Estimation of the Effect: the Bayesian Solution 144
5.7. Some Additional Considerations on the Frequentist
and Bayesian Approaches 146
5.8. Parametric and Non Parametric Inference 149
5.9. Statistical Decision Making in the Medical Field 150
5.10. Evidence Based Medicine 152
Summary 154
6. The Choice of the Sample 157
6.1. Which Subjects Should Form the Sample? 157
6.1.1. Characteristics of the Patients to be Enrolled in the Study 157
6.1.2. Mechanism of Subject Selection 163
6.2. How Many Subjects Should Form the Sample? 164
6.2.1. Statistical Considerations 164
6.2.2. Medical and Practical Aspects 169
Summary 171
7. The Choice of Treatments 172
7.1. Study Treatments 172
7.1.1. How Many Treatments 175
7.1.2. What Treatments 176
7.1.3. Blinding of the Study Treatments 178
7.1.4. Packaging and Logistics 178
7.2. Concomitant Treatments 180
Summary 182
XVI Contents
8. Experimental Design: Fallacy of "Before After" Comparisons
in Uncontrolled Studies 183
8.1. Experimental Design: Introductory Concepts 183
8.2. Before After Comparison in a Single Group of Subjects 185
8.3. Temporal Variations of the Disease 186
8.4. Temporal Variations of Staff, Equipment and Environment. 188
8.5 Statistical Regression Toward the Mean 189
8.5.1. The Basic Principle 189
8.5.2. Areas of Biomedical Experiments Affected by
Regression Toward the Mean 191
8.5.3. How to Minimize the Effect of Regression Toward
the Mean 193
8.6. Learning Effect 195
8.7. Psychological Effect 196
8.8. The Before After Design Without Control Group in Oncology . . 197
Summary 198
9. Experimental Design: the Randomized Blinded Study
as an Instrument to Reduce Bias 200
9.1. Introduction 200
9.2. Randomization as Antidote Against Selection Bias 203
9.2.1. Definition and Conceptual Framework 203
9.2.2. Types of Randomization 206
9.2.3. Other Methods for Assigning Patients to Treatments . 215
9.3. Blinding of Treatments as Antidote Against Assessment Bias . 216
9.4. A Priori Definition of the Statistical Methods and
Populations as Antidote Against the Analysis Bias 221
9.4.1. Methods of Statistical Analysis 221
9.4.2. Analysis Populations 222
9.5. Comparison Between an Observational and an Experimental
Study 224
Summary 227
10. Experiments Designs 228
10.1. ' Introduction 228
10.2. Parallel Group Design 233
10.2.1. Characteristics 233
10.2.2. Advantages and Disadvantages 233
10.2.3. Conditions of Applicability 234
10.3. Variants of the Parallel Group Design 234
10.3.1. Completely Randomized Parallel Group Design 234
10.3.2. Stratified Parallel Group Design 235
10.3.3. Parallel Group Randomized Block Design 239
10.3.4. Balanced Incomplete Block Design 242
Contents XVII
10.4. Other Designs with Comparison Between Subjects:
Dose Escalation and Dose Titration 244
10.4.1. Dose Escalation Design 244
10.4.2. Dose Titration Design 246
10.5. Complete Cross Over Design 247
10.5.1. Characteristics 247
10.5.2. Advantages and Disadvantages 252
10.5.3. Conditions of Applicability 255
10.6. Variants of the Cross Over Design 256
10.6.1.Variants Based on the Type of Randomization 256
10.6.2. Incomplete Cross Over Designs 257
10.7. Other Designs with Within Subject Comparisons:
Simultaneous Treatments and Single Patient Designs 261
10.7.1. Simultaneous Treatments Design 261
10.7.2. Cross Over Design on a Single Patient
(or "N of 1" Design) 261
10.8. Factorial Designs 263
10.8.1. Characteristics 263
10.8.2. Advantages and Disadvantages 268
10.8.3. Conditions of Applicability 270
10.9. Split Plot Design 271
10.9.1. Characteristics 271
10.9.2. Conditions of Applicability 273
10.10. Non Controlled Designs in Phase II Oncology Studies 273
Summary 275
11. Study Variants Applicable to More than One Type of Design:
Equivalence Studies, Interim Analyses, Adaptive Plans
and Repeated Measurements 277
11.1. Equivalence and Non Inferiority Studies 277
11.1.1. Characteristics 277
11.1.2. The Statistical Analysis of an Equivalence Study 280
11.1.3. Planning and Implementation Problems 281
11.1.4. Analysis and Interpretation Problems 285
11.2. Studies with Interim Analyses and Sequential Designs 287
11.2.1. Definitions and Classification 288
11.2.2. Conditions of Applicability 290
11.2.3. Choice of the End Points 292
11.2.4. Data Management Issues 293
11.2.5. Statistical Issues and Decision Making Criteria 294
11.2.6. Conflict of Interest and Confidentiality Issues 298
11.3. Adaptive (Flexible) Designs 299
11.4. Studies with Repeated Measurements 301
Summary 302
XVIII Contents
12.The Drug Development Process and the Phases of Clinical sx
Research 304
12.1. Overview of the Preclinical Development Process 304
12.2. The Phases of Clinical Development 308
12.2.1. Introduction 308
12.2.2. Phase I 309
12.2.3. Phase II 311
12.2.4. Phase III 313
12.2.5. Registration Dossier 315
12.2.6. Phase IV 319
12.2.7. Project Management 321
12.3. The Phases of Clinical Development for Oncology Compounds . 322
12.3.1. Phase I 322
12.3.2. Phase II 323
12.3.3. Phase III 323
12.4. Accelerating Clinical Development 325
Summary 327
Appendix: Areas under the Curve of the Standard Normal Distribution. . 329
References 331
Analytical Index 337 |
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| doi_str_mv | 10.1007/978-88-470-0492-4 |
| format | Electronic eBook |
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| id | DE-604.BV022866761 |
| illustrated | Not Illustrated |
| index_date | 2024-07-02T18:45:33Z |
| indexdate | 2025-02-20T07:03:41Z |
| institution | BVB |
| isbn | 9788847004924 |
| language | English Italian |
| lccn | 2006938039 |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-016071925 |
| oclc_num | 1184300357 |
| open_access_boolean | |
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| owner_facet | DE-355 DE-BY-UBR DE-188 DE-12 DE-384 DE-473 DE-BY-UBG DE-703 DE-29 DE-19 DE-BY-UBM DE-91 DE-BY-TUM DE-739 DE-20 DE-706 DE-1046 DE-1047 DE-1102 DE-858 DE-1028 DE-573 DE-859 DE-860 DE-M347 DE-1049 DE-92 DE-898 DE-BY-UBR DE-863 DE-BY-FWS DE-862 DE-BY-FWS DE-128 DE-54 DE-22 DE-BY-UBG DE-150 DE-155 DE-BY-UBR DE-2070s DE-521 DE-522 DE-526 DE-11 DE-83 DE-70 DE-634 |
| physical | 1 Online-Ressource (XXV, 337 S.) graph. Darst. |
| psigel | ZDB-1-SMI ZDB-2-SME |
| publishDate | 2007 |
| publishDateSearch | 2007 |
| publishDateSort | 2007 |
| publisher | Springer |
| record_format | marc |
| series2 | Statistics for biology and health |
| spellingShingle | Bacchieri, Antonella Della Cioppa, Giovanni Fundamentals of clinical research bridging medicine, statistics and operations Medizin Medicine Research Biomedical Research methods Research Design Biomedizin (DE-588)4647152-2 gnd Biostatistik (DE-588)4729990-3 gnd Forschungsplanung (DE-588)4155051-1 gnd |
| subject_GND | (DE-588)4647152-2 (DE-588)4729990-3 (DE-588)4155051-1 |
| title | Fundamentals of clinical research bridging medicine, statistics and operations |
| title_alt | Fondamenti di ricerca clinica |
| title_auth | Fundamentals of clinical research bridging medicine, statistics and operations |
| title_exact_search | Fundamentals of clinical research bridging medicine, statistics and operations |
| title_exact_search_txtP | Fundamentals of clinical research bridging medicine, statistics and operations |
| title_full | Fundamentals of clinical research bridging medicine, statistics and operations Antonella Bacchieri ; Giovanni Della Cioppa |
| title_fullStr | Fundamentals of clinical research bridging medicine, statistics and operations Antonella Bacchieri ; Giovanni Della Cioppa |
| title_full_unstemmed | Fundamentals of clinical research bridging medicine, statistics and operations Antonella Bacchieri ; Giovanni Della Cioppa |
| title_short | Fundamentals of clinical research |
| title_sort | fundamentals of clinical research bridging medicine statistics and operations |
| title_sub | bridging medicine, statistics and operations |
| topic | Medizin Medicine Research Biomedical Research methods Research Design Biomedizin (DE-588)4647152-2 gnd Biostatistik (DE-588)4729990-3 gnd Forschungsplanung (DE-588)4155051-1 gnd |
| topic_facet | Medizin Medicine Research Biomedical Research methods Research Design Biomedizin Biostatistik Forschungsplanung |
| url | https://doi.org/10.1007/978-88-470-0492-4 http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=016071925&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| work_keys_str_mv | AT bacchieriantonella fondamentidiricercaclinica AT dellacioppagiovanni fondamentidiricercaclinica AT bacchieriantonella fundamentalsofclinicalresearchbridgingmedicinestatisticsandoperations AT dellacioppagiovanni fundamentalsofclinicalresearchbridgingmedicinestatisticsandoperations |