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Clinical trials [[electronic resource] ] : study design, endpoints and biomarkers, drug safety, FDA and ICH guidelines / / Tom Brody
Clinical trials [[electronic resource] ] : study design, endpoints and biomarkers, drug safety, FDA and ICH guidelines / / Tom Brody
Autore Brody Tom
Edizione [1st ed.]
Pubbl/distr/stampa London, : Academic Press, 2012
Descrizione fisica 1 online resource (673 p.)
Disciplina 615.19
615.50724
615/.19
Soggetto topico Clinical trials
Drugs - Testing
Soggetto genere / forma Electronic books.
ISBN 1-283-32021-5
9786613320216
0-12-391913-4
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Front Cover; Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, FDA and ICH Guidelines; Copyright Page; Contents; Acknowledgments; Preface; The Study Schema and Study Design; Intent to Treat Analysis; How to Choose the Endpoints; Diagnostic Tests; Mechanism of Action; Standards; Methodology; Clinicaltrials.Gov and other Registries for Clinical Trials; Introduction; Abbreviations and Definitions; Biography; 1 The Origins of Drugs; I. Introduction; II. Structures of Drugs; a. Origins of warfarin; b. Origins of methotrexate and 5-fluorouracil; c. Origins of ribavirin
d. Origins of paclitaxele. Origins of cladribine; f. Origins of drugs in high-throughput screening; g. Origins of therapeutic antibodies; III. The 20 Classical Amino Acids; IV. Animal Models; a. Introduction; b. Estimating human dose from animal studies; 1. NOAEL approach; 2. MABEL approach; c. Scaling up the drug dose, acquired from animal studies, for use in humans; 2 Introduction to Regulated Clinical Trials; I. Introduction; II. Study Design; III. The Study Schema; a. Examples of schema from clinical trials; b. Sequential treatment versus concurrent treatment - the Perez schema
c. Neoadjuvant chemotherapy versus adjuvant chemotherapy - the Gianni schemad. Neoadjuvant chemotherapy plus adjuvant chemotherapy - the Untch schema; e. Forwards sequence and reverse sequence - the Puhalla schema; f. Both arms received three drugs, each arm at a different schedule - the Sekine schema; g. Staging - the Blumenschein schema; h. Staging and restaging - the Czito schema; i. Methodology tip - staging; j. Decision tree - the Baselga schema; k. Decision tree - the Katsumata schema; l. Methodology tip - what is "tumor progression"?
m. Methodology tip - unit of drug dose expressed in terms of body surface arean. Run-in period - the schema of Dy; o. Methodology tip - c-kit and imatinib; p. Run-in period - the Hanna schema; q. How to maintain blinding of the treatment, when the study drug and the control treatment are provided by different-sized pills (or by different volumes of solutions)...; r. Methodology tip - bevacizumab and VEGF; s. Dose escalation - the Moore schema; t. Pharmacokinetics - the Marshall schema; IV. Further Concepts In Study Design; a. Active control; b. Add-on design active control
c. Three-arm study - clinical trial with two different active control armsV. Summary; VI. Amendments to the Clinical Study Protocol; 3 Run-In Period; I. Introduction; a. Washout period; b. Detecting baseline adverse events; c. Excluding potential study subjects who have safety issues correlating with the study drug; d. To include only study subjects with controllable pain; e. To determine the maximal tolerable dose; f. To achieve and ensure steady state in vivo concentrations of study drug
g. To allow a period of adjustment of lifestyle of the study subjects, for example changes in dietary patterns
Record Nr. UNINA-9910457469003321
Brody Tom  
London, : Academic Press, 2012
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Clinical trials [[electronic resource] ] : study design, endpoints and biomarkers, drug safety, FDA and ICH guidelines / / Tom Brody
Clinical trials [[electronic resource] ] : study design, endpoints and biomarkers, drug safety, FDA and ICH guidelines / / Tom Brody
Autore Brody Tom
Edizione [1st ed.]
Pubbl/distr/stampa London, : Academic Press, 2012
Descrizione fisica 1 online resource (673 p.)
Disciplina 615.19
615.50724
615/.19
Soggetto topico Clinical trials
Drugs - Testing
ISBN 1-283-32021-5
9786613320216
0-12-391913-4
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Front Cover; Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, FDA and ICH Guidelines; Copyright Page; Contents; Acknowledgments; Preface; The Study Schema and Study Design; Intent to Treat Analysis; How to Choose the Endpoints; Diagnostic Tests; Mechanism of Action; Standards; Methodology; Clinicaltrials.Gov and other Registries for Clinical Trials; Introduction; Abbreviations and Definitions; Biography; 1 The Origins of Drugs; I. Introduction; II. Structures of Drugs; a. Origins of warfarin; b. Origins of methotrexate and 5-fluorouracil; c. Origins of ribavirin
d. Origins of paclitaxele. Origins of cladribine; f. Origins of drugs in high-throughput screening; g. Origins of therapeutic antibodies; III. The 20 Classical Amino Acids; IV. Animal Models; a. Introduction; b. Estimating human dose from animal studies; 1. NOAEL approach; 2. MABEL approach; c. Scaling up the drug dose, acquired from animal studies, for use in humans; 2 Introduction to Regulated Clinical Trials; I. Introduction; II. Study Design; III. The Study Schema; a. Examples of schema from clinical trials; b. Sequential treatment versus concurrent treatment - the Perez schema
c. Neoadjuvant chemotherapy versus adjuvant chemotherapy - the Gianni schemad. Neoadjuvant chemotherapy plus adjuvant chemotherapy - the Untch schema; e. Forwards sequence and reverse sequence - the Puhalla schema; f. Both arms received three drugs, each arm at a different schedule - the Sekine schema; g. Staging - the Blumenschein schema; h. Staging and restaging - the Czito schema; i. Methodology tip - staging; j. Decision tree - the Baselga schema; k. Decision tree - the Katsumata schema; l. Methodology tip - what is "tumor progression"?
m. Methodology tip - unit of drug dose expressed in terms of body surface arean. Run-in period - the schema of Dy; o. Methodology tip - c-kit and imatinib; p. Run-in period - the Hanna schema; q. How to maintain blinding of the treatment, when the study drug and the control treatment are provided by different-sized pills (or by different volumes of solutions)...; r. Methodology tip - bevacizumab and VEGF; s. Dose escalation - the Moore schema; t. Pharmacokinetics - the Marshall schema; IV. Further Concepts In Study Design; a. Active control; b. Add-on design active control
c. Three-arm study - clinical trial with two different active control armsV. Summary; VI. Amendments to the Clinical Study Protocol; 3 Run-In Period; I. Introduction; a. Washout period; b. Detecting baseline adverse events; c. Excluding potential study subjects who have safety issues correlating with the study drug; d. To include only study subjects with controllable pain; e. To determine the maximal tolerable dose; f. To achieve and ensure steady state in vivo concentrations of study drug
g. To allow a period of adjustment of lifestyle of the study subjects, for example changes in dietary patterns
Record Nr. UNINA-9910781962303321
Brody Tom  
London, : Academic Press, 2012
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Clinical trials : study design, endpoints and biomarkers, drug safety, FDA and ICH guidelines / / Tom Brody
Clinical trials : study design, endpoints and biomarkers, drug safety, FDA and ICH guidelines / / Tom Brody
Autore Brody Tom
Edizione [1st ed.]
Pubbl/distr/stampa London, : Academic Press, 2012
Descrizione fisica 1 online resource (673 p.)
Disciplina 615.19
615.50724
615/.19
Soggetto topico Clinical trials
Drugs - Testing
ISBN 1-283-32021-5
9786613320216
0-12-391913-4
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Front Cover; Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, FDA and ICH Guidelines; Copyright Page; Contents; Acknowledgments; Preface; The Study Schema and Study Design; Intent to Treat Analysis; How to Choose the Endpoints; Diagnostic Tests; Mechanism of Action; Standards; Methodology; Clinicaltrials.Gov and other Registries for Clinical Trials; Introduction; Abbreviations and Definitions; Biography; 1 The Origins of Drugs; I. Introduction; II. Structures of Drugs; a. Origins of warfarin; b. Origins of methotrexate and 5-fluorouracil; c. Origins of ribavirin
d. Origins of paclitaxele. Origins of cladribine; f. Origins of drugs in high-throughput screening; g. Origins of therapeutic antibodies; III. The 20 Classical Amino Acids; IV. Animal Models; a. Introduction; b. Estimating human dose from animal studies; 1. NOAEL approach; 2. MABEL approach; c. Scaling up the drug dose, acquired from animal studies, for use in humans; 2 Introduction to Regulated Clinical Trials; I. Introduction; II. Study Design; III. The Study Schema; a. Examples of schema from clinical trials; b. Sequential treatment versus concurrent treatment - the Perez schema
c. Neoadjuvant chemotherapy versus adjuvant chemotherapy - the Gianni schemad. Neoadjuvant chemotherapy plus adjuvant chemotherapy - the Untch schema; e. Forwards sequence and reverse sequence - the Puhalla schema; f. Both arms received three drugs, each arm at a different schedule - the Sekine schema; g. Staging - the Blumenschein schema; h. Staging and restaging - the Czito schema; i. Methodology tip - staging; j. Decision tree - the Baselga schema; k. Decision tree - the Katsumata schema; l. Methodology tip - what is "tumor progression"?
m. Methodology tip - unit of drug dose expressed in terms of body surface arean. Run-in period - the schema of Dy; o. Methodology tip - c-kit and imatinib; p. Run-in period - the Hanna schema; q. How to maintain blinding of the treatment, when the study drug and the control treatment are provided by different-sized pills (or by different volumes of solutions)...; r. Methodology tip - bevacizumab and VEGF; s. Dose escalation - the Moore schema; t. Pharmacokinetics - the Marshall schema; IV. Further Concepts In Study Design; a. Active control; b. Add-on design active control
c. Three-arm study - clinical trial with two different active control armsV. Summary; VI. Amendments to the Clinical Study Protocol; 3 Run-In Period; I. Introduction; a. Washout period; b. Detecting baseline adverse events; c. Excluding potential study subjects who have safety issues correlating with the study drug; d. To include only study subjects with controllable pain; e. To determine the maximal tolerable dose; f. To achieve and ensure steady state in vivo concentrations of study drug
g. To allow a period of adjustment of lifestyle of the study subjects, for example changes in dietary patterns
Record Nr. UNINA-9910817835703321
Brody Tom  
London, : Academic Press, 2012
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Clinical trials : design, conduct, and analysis / / Curtis L. Meinert
Clinical trials : design, conduct, and analysis / / Curtis L. Meinert
Autore Meinert Curtis L.
Edizione [Second edition.]
Pubbl/distr/stampa New York, New York : , : Oxford University Press, , 2012
Descrizione fisica 1 online resource (702 p.)
Disciplina 616.0750724
Collana Monographs in Epidemiology and Biostatistics
Soggetto topico Clinical trials
Soggetto genere / forma Electronic books.
ISBN 0-19-991025-1
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Cover; Contents; PART 1. INTRODUCTION; Chapter 1 Introduction; 1.1 Clinical trial: Definition; 1.2 History of clinical trials; 1.3 Trials today; 1.4 Terminology: Conventions and definitions; 1.5 Focus; Chapter 2 The language of clinical trials; 2.1 Introduction; 2.2 On the language of relativity; 2.3 Random: The term; 2.4 The language of the epidemiologist vs the trialist; 2.5 Terminology: Recommendations and comments; Chapter 3 Types and classes of trials; 3.1 Introduction; 3.2 Treatment structure; 3.3 Sample size design; 3.4 Masking design; 3.5 Single-center and multicenter trials
3.6 Purpose3.7 Treatment modality; 3.8 Big and simple trials; 3.9 Industry trials versus academic trials; Chapter 4 The state and nature of trials; 4.1 Introduction; 4.2 On assessing the state and nature of trials; 4.3 Published trials; 4.4 Gender-specific trials; 4.5 The Cochrane Library; 4.6 Registration of trials; 4.7 Registries of trials; 4.8 Other state measures; Chapter 5 The activities of clinical trials; 5.1 Stages of activities; 5.2 Division of responsibilities; 5.3 Impediments to performance of activities; 5.4 Aids to ensuring orderly transition of activities
Chapter 6 Coordinating and other resource centers in multicenter trials6.1 Introduction; 6.2 Coordinating centers; 6.3 Study chair and office of the study chair; 6.4 Central laboratories; 6.5 Reading centers; 6.6 Project offices; 6.7 Support centers; Chapter 7 Multi-study networks; 7.1 Introduction; 7.2 Examples of networks; 7.3 Advantages and disadvantages; 7.4 Modes of creation and funding; 7.5 Organizational structures; 7.6 Operating structures; Chapter 8 Ethical principles and imperatives in clinical trials; 8.1 Introduction; 8.2 Medical research codes
8.3 Principles of medical ethics in research8.4 The state of clinical equipoise; 8.5 The ethics of choice of study treatments; 8.6 The monitoring imperative; 8.7 The ethics of disclosures for consents and of confl icts of interest; Chapter 9 Objectivity versus competency in clinical trials; 9.1 Introduction; 9.2 Objectivity constructs and rules; 9.3 Ethical limits of imposed objectivity constructs; PART 2. DESIGN PRINCIPLES AND PRACTICES; Chapter 10 Fundamentals of controlled clinical trials; 10.1 Introduction; 10.2 Choice of the test and control treatments
10.3 Principles in the selection of the outcome measure10.4 Principles of establishing comparable treatment groups; 10.5 Principles of masking and bias control; Chapter 11 Bias; 11.1 Introduction; 11.2 Absolute versus relative truth and bias; 11.3 Selection and representation biases; 11.4 Treatment-related biases; 11.5 Indicators of bias; 11.6 Bias "fix," avoidance, and prevention strategies; Chapter 12 Bias control; 12.1 Introduction; 12.2 Randomization; 12.3 Concealment; 12.4 Masking philosophy of the trialist; 12.5 Specificity, training, and surveillance
12.6 Separation and isolation of functions
Record Nr. UNINA-9910453436003321
Meinert Curtis L.  
New York, New York : , : Oxford University Press, , 2012
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Clinical trials : design, conduct, and analysis / / Curtis L. Meinert
Clinical trials : design, conduct, and analysis / / Curtis L. Meinert
Autore Meinert Curtis L.
Edizione [Second edition.]
Pubbl/distr/stampa New York, New York : , : Oxford University Press, , 2012
Descrizione fisica 1 online resource (702 p.)
Disciplina 616.0750724
Collana Monographs in Epidemiology and Biostatistics
Soggetto topico Clinical trials
ISBN 0-19-991025-1
Classificazione MED106000MED028000
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Cover; Contents; PART 1. INTRODUCTION; Chapter 1 Introduction; 1.1 Clinical trial: Definition; 1.2 History of clinical trials; 1.3 Trials today; 1.4 Terminology: Conventions and definitions; 1.5 Focus; Chapter 2 The language of clinical trials; 2.1 Introduction; 2.2 On the language of relativity; 2.3 Random: The term; 2.4 The language of the epidemiologist vs the trialist; 2.5 Terminology: Recommendations and comments; Chapter 3 Types and classes of trials; 3.1 Introduction; 3.2 Treatment structure; 3.3 Sample size design; 3.4 Masking design; 3.5 Single-center and multicenter trials
3.6 Purpose3.7 Treatment modality; 3.8 Big and simple trials; 3.9 Industry trials versus academic trials; Chapter 4 The state and nature of trials; 4.1 Introduction; 4.2 On assessing the state and nature of trials; 4.3 Published trials; 4.4 Gender-specific trials; 4.5 The Cochrane Library; 4.6 Registration of trials; 4.7 Registries of trials; 4.8 Other state measures; Chapter 5 The activities of clinical trials; 5.1 Stages of activities; 5.2 Division of responsibilities; 5.3 Impediments to performance of activities; 5.4 Aids to ensuring orderly transition of activities
Chapter 6 Coordinating and other resource centers in multicenter trials6.1 Introduction; 6.2 Coordinating centers; 6.3 Study chair and office of the study chair; 6.4 Central laboratories; 6.5 Reading centers; 6.6 Project offices; 6.7 Support centers; Chapter 7 Multi-study networks; 7.1 Introduction; 7.2 Examples of networks; 7.3 Advantages and disadvantages; 7.4 Modes of creation and funding; 7.5 Organizational structures; 7.6 Operating structures; Chapter 8 Ethical principles and imperatives in clinical trials; 8.1 Introduction; 8.2 Medical research codes
8.3 Principles of medical ethics in research8.4 The state of clinical equipoise; 8.5 The ethics of choice of study treatments; 8.6 The monitoring imperative; 8.7 The ethics of disclosures for consents and of confl icts of interest; Chapter 9 Objectivity versus competency in clinical trials; 9.1 Introduction; 9.2 Objectivity constructs and rules; 9.3 Ethical limits of imposed objectivity constructs; PART 2. DESIGN PRINCIPLES AND PRACTICES; Chapter 10 Fundamentals of controlled clinical trials; 10.1 Introduction; 10.2 Choice of the test and control treatments
10.3 Principles in the selection of the outcome measure10.4 Principles of establishing comparable treatment groups; 10.5 Principles of masking and bias control; Chapter 11 Bias; 11.1 Introduction; 11.2 Absolute versus relative truth and bias; 11.3 Selection and representation biases; 11.4 Treatment-related biases; 11.5 Indicators of bias; 11.6 Bias "fix," avoidance, and prevention strategies; Chapter 12 Bias control; 12.1 Introduction; 12.2 Randomization; 12.3 Concealment; 12.4 Masking philosophy of the trialist; 12.5 Specificity, training, and surveillance
12.6 Separation and isolation of functions
Record Nr. UNINA-9910791210503321
Meinert Curtis L.  
New York, New York : , : Oxford University Press, , 2012
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Clinical trials : design, conduct, and analysis / / Curtis L. Meinert
Clinical trials : design, conduct, and analysis / / Curtis L. Meinert
Autore Meinert Curtis L.
Edizione [Second edition.]
Pubbl/distr/stampa New York, New York : , : Oxford University Press, , 2012
Descrizione fisica 1 online resource (702 p.)
Disciplina 616.0750724
Collana Monographs in Epidemiology and Biostatistics
Soggetto topico Clinical trials
ISBN 0-19-991025-1
Classificazione MED106000MED028000
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Cover; Contents; PART 1. INTRODUCTION; Chapter 1 Introduction; 1.1 Clinical trial: Definition; 1.2 History of clinical trials; 1.3 Trials today; 1.4 Terminology: Conventions and definitions; 1.5 Focus; Chapter 2 The language of clinical trials; 2.1 Introduction; 2.2 On the language of relativity; 2.3 Random: The term; 2.4 The language of the epidemiologist vs the trialist; 2.5 Terminology: Recommendations and comments; Chapter 3 Types and classes of trials; 3.1 Introduction; 3.2 Treatment structure; 3.3 Sample size design; 3.4 Masking design; 3.5 Single-center and multicenter trials
3.6 Purpose3.7 Treatment modality; 3.8 Big and simple trials; 3.9 Industry trials versus academic trials; Chapter 4 The state and nature of trials; 4.1 Introduction; 4.2 On assessing the state and nature of trials; 4.3 Published trials; 4.4 Gender-specific trials; 4.5 The Cochrane Library; 4.6 Registration of trials; 4.7 Registries of trials; 4.8 Other state measures; Chapter 5 The activities of clinical trials; 5.1 Stages of activities; 5.2 Division of responsibilities; 5.3 Impediments to performance of activities; 5.4 Aids to ensuring orderly transition of activities
Chapter 6 Coordinating and other resource centers in multicenter trials6.1 Introduction; 6.2 Coordinating centers; 6.3 Study chair and office of the study chair; 6.4 Central laboratories; 6.5 Reading centers; 6.6 Project offices; 6.7 Support centers; Chapter 7 Multi-study networks; 7.1 Introduction; 7.2 Examples of networks; 7.3 Advantages and disadvantages; 7.4 Modes of creation and funding; 7.5 Organizational structures; 7.6 Operating structures; Chapter 8 Ethical principles and imperatives in clinical trials; 8.1 Introduction; 8.2 Medical research codes
8.3 Principles of medical ethics in research8.4 The state of clinical equipoise; 8.5 The ethics of choice of study treatments; 8.6 The monitoring imperative; 8.7 The ethics of disclosures for consents and of confl icts of interest; Chapter 9 Objectivity versus competency in clinical trials; 9.1 Introduction; 9.2 Objectivity constructs and rules; 9.3 Ethical limits of imposed objectivity constructs; PART 2. DESIGN PRINCIPLES AND PRACTICES; Chapter 10 Fundamentals of controlled clinical trials; 10.1 Introduction; 10.2 Choice of the test and control treatments
10.3 Principles in the selection of the outcome measure10.4 Principles of establishing comparable treatment groups; 10.5 Principles of masking and bias control; Chapter 11 Bias; 11.1 Introduction; 11.2 Absolute versus relative truth and bias; 11.3 Selection and representation biases; 11.4 Treatment-related biases; 11.5 Indicators of bias; 11.6 Bias "fix," avoidance, and prevention strategies; Chapter 12 Bias control; 12.1 Introduction; 12.2 Randomization; 12.3 Concealment; 12.4 Masking philosophy of the trialist; 12.5 Specificity, training, and surveillance
12.6 Separation and isolation of functions
Record Nr. UNINA-9910825300503321
Meinert Curtis L.  
New York, New York : , : Oxford University Press, , 2012
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Clinical trials : a practical approach / / Stuart J. Pocock
Clinical trials : a practical approach / / Stuart J. Pocock
Autore Pocock Stuart J.
Pubbl/distr/stampa Chichester, England : , : John Wiley & Sons, , 1983
Descrizione fisica 1 online resource (280 p.)
Disciplina 615/.7/0724
Collana A Wiley medical publication Clinical trials
Soggetto topico Clinical trials
ISBN 1-118-79391-9
1-118-79392-7
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Cover; Title Page; Contents; Preface; 1. Introduction: The Rationale of Clinical Trials; 1.1 Types of clinical trial; 1.2 Controlled clinical trials and the scientific method; 1.3 An example of a clinical trial for primary breast cancer; 2. The Historical Development of Clinical Trials; 2.1 Clinical trials before 1950; 2.2 Clinical trials since 1950; 2.3 Cancer chemotherapy in the United States; 2.4 Treatment of acute myocardial infarction; 2.5 The pharmaceutical industry; 3. Organization and Planning; 3.1 The protocol; 3.2 Administration, staff and finance; 3.3 Selection of patients
3.4 Treatment schedules 3.5 Evaluation of patient response; 4. The Justification for Randomized Controlled Trials; 4.1 Problems with uncontrolled trials; 4.2 Problems with historical controls; 4.3 Problems with concurrent non-randomized controls; 4.4 Is randomization feasible?; 5. Methods of Randomization; 5.1 Patient registration; 5.2 Preparing the randomization list; 5.3 Stratified randomization; 5.4 Unequal randomization; 6. Blinding and Placebos; 6.1 The justification for double-blind trials; 6.2 The conduct of double-blind trials; 6.3 When is blinding feasible?; 7. Ethical Issues
7.1 Medical progress and individual patient care 7.2 Informed patient consent; 8. Crossover Trials; 8.1 Within-patient comparisons; 8.2 The two-period crossover design; 8.3 The analysis and interpretation of crossover trials; 8.4 Multi-period crossover designs; 9. The Size of a Clinical Trial; 9.1 Statistical methods for determining trial size; 9.2 The realistic assessment of trial size; 9.3 The inadequacy of small trials; 9.4 Multi-centre trials; 9.5 The number of treatments and factorial designs; 10. Monitoring Trial Progress; 10.1 Reasons for monitoring; 10.2 Interim analyses
10.3 Repeated significance testing: group sequential designs 10.4 Continuous sequential designs; 11. Forms and Data Management; 11.1 Form design; 11.2 Data management; 11.3 The use of computers; 12. Protocol Deviations; 12.1 Ineligible patients; 12.2 Non-compliance and incomplete evaluation; 12.3 Inclusion of withdrawals in analysis; 13. Basic Principles of Statistical Analysis; 13.1 Describing the data; 13.2 Significance tests; 13.3 Estimation and confidence limits; 14. Further Aspects of Data Analysis; 14.1 Prognostic factors; 14.2 The analysis of survival data; 14.3 Multiplicity of data
15. Publication and Interpretation of Findings 15.1 Trial reports and their critical evaluation; 15.2 An excess of false-positives; 15.3 Combining evidence and overall strategy; References; Index
Record Nr. UNINA-9910133694103321
Pocock Stuart J.  
Chichester, England : , : John Wiley & Sons, , 1983
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Clinical trials : a practical approach / / Stuart J. Pocock
Clinical trials : a practical approach / / Stuart J. Pocock
Autore Pocock Stuart J.
Pubbl/distr/stampa Chichester, England : , : John Wiley & Sons, , 1983
Descrizione fisica 1 online resource (280 p.)
Disciplina 615/.7/0724
Collana A Wiley medical publication Clinical trials
Soggetto topico Clinical trials
ISBN 1-118-79391-9
1-118-79392-7
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Cover; Title Page; Contents; Preface; 1. Introduction: The Rationale of Clinical Trials; 1.1 Types of clinical trial; 1.2 Controlled clinical trials and the scientific method; 1.3 An example of a clinical trial for primary breast cancer; 2. The Historical Development of Clinical Trials; 2.1 Clinical trials before 1950; 2.2 Clinical trials since 1950; 2.3 Cancer chemotherapy in the United States; 2.4 Treatment of acute myocardial infarction; 2.5 The pharmaceutical industry; 3. Organization and Planning; 3.1 The protocol; 3.2 Administration, staff and finance; 3.3 Selection of patients
3.4 Treatment schedules 3.5 Evaluation of patient response; 4. The Justification for Randomized Controlled Trials; 4.1 Problems with uncontrolled trials; 4.2 Problems with historical controls; 4.3 Problems with concurrent non-randomized controls; 4.4 Is randomization feasible?; 5. Methods of Randomization; 5.1 Patient registration; 5.2 Preparing the randomization list; 5.3 Stratified randomization; 5.4 Unequal randomization; 6. Blinding and Placebos; 6.1 The justification for double-blind trials; 6.2 The conduct of double-blind trials; 6.3 When is blinding feasible?; 7. Ethical Issues
7.1 Medical progress and individual patient care 7.2 Informed patient consent; 8. Crossover Trials; 8.1 Within-patient comparisons; 8.2 The two-period crossover design; 8.3 The analysis and interpretation of crossover trials; 8.4 Multi-period crossover designs; 9. The Size of a Clinical Trial; 9.1 Statistical methods for determining trial size; 9.2 The realistic assessment of trial size; 9.3 The inadequacy of small trials; 9.4 Multi-centre trials; 9.5 The number of treatments and factorial designs; 10. Monitoring Trial Progress; 10.1 Reasons for monitoring; 10.2 Interim analyses
10.3 Repeated significance testing: group sequential designs 10.4 Continuous sequential designs; 11. Forms and Data Management; 11.1 Form design; 11.2 Data management; 11.3 The use of computers; 12. Protocol Deviations; 12.1 Ineligible patients; 12.2 Non-compliance and incomplete evaluation; 12.3 Inclusion of withdrawals in analysis; 13. Basic Principles of Statistical Analysis; 13.1 Describing the data; 13.2 Significance tests; 13.3 Estimation and confidence limits; 14. Further Aspects of Data Analysis; 14.1 Prognostic factors; 14.2 The analysis of survival data; 14.3 Multiplicity of data
15. Publication and Interpretation of Findings 15.1 Trial reports and their critical evaluation; 15.2 An excess of false-positives; 15.3 Combining evidence and overall strategy; References; Index
Record Nr. UNINA-9910818732603321
Pocock Stuart J.  
Chichester, England : , : John Wiley & Sons, , 1983
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Clinical trials [[electronic resource] ] : questions and answers
Clinical trials [[electronic resource] ] : questions and answers
Pubbl/distr/stampa [Bethesda, Md.] : , : National Cancer Institute, , [2006]
Descrizione fisica 11 pages : digital, PDF file
Collana Fact sheet
Soggetto topico Clinical trials
Cancer - Treatment
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Altri titoli varianti Clinical Trials
Record Nr. UNINA-9910698581903321
[Bethesda, Md.] : , : National Cancer Institute, , [2006]
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Clinical trials
Clinical trials
Pubbl/distr/stampa London, : Arnold, ©2004-
Disciplina 616
Soggetto topico Clinical trials
Clinical Trials as Topic
Therapies, Investigational
Research Design
Études cliniques
Soggetto genere / forma Periodical
Periodicals.
ISSN 1740-7753
Formato Materiale a stampa
Livello bibliografico Periodico
Lingua di pubblicazione eng
Altri titoli varianti Journal of the Society for Clinical Trials
Record Nr. UNISA-996251306403316
London, : Arnold, ©2004-
Materiale a stampa
Lo trovi qui: Univ. di Salerno
Opac: Controlla la disponibilità qui