The Resource Clinical trials : study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines, by Tom Brody, (electronic book)
Clinical trials : study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines, by Tom Brody, (electronic book)
Resource Information
The item Clinical trials : study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines, by Tom Brody, (electronic book) represents a specific, individual, material embodiment of a distinct intellectual or artistic creation found in University of Liverpool.This item is available to borrow from 1 library branch.
Resource Information
The item Clinical trials : study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines, by Tom Brody, (electronic book) represents a specific, individual, material embodiment of a distinct intellectual or artistic creation found in University of Liverpool.
This item is available to borrow from 1 library branch.
- Summary
- Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive information on both US and international regulatory guidelines and features concrete examples of study design from the medical literature. This book is intended to orient those new to clinical trial design and provide them with a better understanding of how to conduct clinical trials. It will also act as a guide for the more experienced by detailing endpoint selection and illustrating how to avoid unnecessary pitfalls. This book is a straightforward and valuable reference for all those involved in clinical trial design. Provides extensive coverage of the "study schema" and related features of study design Offers a "hands-on" reference that contains an overview of the process, but more importantly details a step-by-step account of clinical trial design Features examples from the medical literature to highlight how investigators choose the most suitable endpoint(s) for clinical trial and includes graphs from real clinical trials to help explain each concept in study design Integrates clinical trial design, pharmacology, biochemistry, cell biology and legal aspects to provide readers with a comprehensive look at all aspects of clinical trials
- Language
- eng
- Extent
- 1 online resource (xxxiii, 638 p.)
- Contents
-
- Introduction. Abbreviations and definitions. Biography. 1. The Origins of Drugs 2. Introduction to regulated clinical trials 3. Run-in Period 4. Inclusion/exclusion criteria, stratification, and subgroups, Part I 5. Inclusion and stratification criteria, Part II 6. Randomization, allocation, and blinding 7. Placebo arm as part of clinical study design 8. Intent to treat analysis vs. per protocol analysis 9. Biostatistics 10. Introduction to endpoints for clinical trials in pharmacology 11. Endpoints in clinical trials on solid tumors : objective response 12. Oncology endpoint: overall survival and progression-free survival 13. Oncology endpoint: time to progression 14. Oncology endpoint: disease-free survival 15. Oncology endpoint: time to distant metastasis 16. Neoadjuvant therapy versus adjuvant therapy 17. Hematological cancers 18. Biomarkers and personalized medicine 19. Endpoints in immune diseases 20. Endpoints in clinical trials on infections 21. Health-related quality of life 22. Health-related quality of life instruments for immune disorders 23. Health-related quality of life instruments and Infections 24. Drug safety 25. Mechanism of action, Part I 26. Mechanism of Action, Part II: Cancer 27. Mechanism of Action, Part III: Immune Diseases 28. Mechanism of Action, Part IV: Infections 29. Consent Forms 30. Package Inserts 31. Regulatory Approval 32. Patents. Index
- Isbn
- 9780123919137
- Label
- Clinical trials : study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines
- Title
- Clinical trials
- Title remainder
- study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines
- Statement of responsibility
- by Tom Brody
- Language
- eng
- Summary
- Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive information on both US and international regulatory guidelines and features concrete examples of study design from the medical literature. This book is intended to orient those new to clinical trial design and provide them with a better understanding of how to conduct clinical trials. It will also act as a guide for the more experienced by detailing endpoint selection and illustrating how to avoid unnecessary pitfalls. This book is a straightforward and valuable reference for all those involved in clinical trial design. Provides extensive coverage of the "study schema" and related features of study design Offers a "hands-on" reference that contains an overview of the process, but more importantly details a step-by-step account of clinical trial design Features examples from the medical literature to highlight how investigators choose the most suitable endpoint(s) for clinical trial and includes graphs from real clinical trials to help explain each concept in study design Integrates clinical trial design, pharmacology, biochemistry, cell biology and legal aspects to provide readers with a comprehensive look at all aspects of clinical trials
- Cataloging source
- OPELS
- http://library.link/vocab/creatorName
- Brody, Tom
- Dewey number
- 615.50724
- Illustrations
- illustrations
- Index
- index present
- LC call number
- R853.C55
- LC item number
- B76 2012
- Literary form
- non fiction
- Nature of contents
-
- dictionaries
- bibliography
- http://library.link/vocab/subjectName
-
- Clinical trials
- Clinical Trials as Topic
- Clinical Trials Data Monitoring Committees
- Drug Approval
- Research Design
- Label
- Clinical trials : study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines, by Tom Brody, (electronic book)
- Bibliography note
- Includes bibliographical references and index
- Color
- multicolored
- Contents
- Introduction. Abbreviations and definitions. Biography. 1. The Origins of Drugs 2. Introduction to regulated clinical trials 3. Run-in Period 4. Inclusion/exclusion criteria, stratification, and subgroups, Part I 5. Inclusion and stratification criteria, Part II 6. Randomization, allocation, and blinding 7. Placebo arm as part of clinical study design 8. Intent to treat analysis vs. per protocol analysis 9. Biostatistics 10. Introduction to endpoints for clinical trials in pharmacology 11. Endpoints in clinical trials on solid tumors : objective response 12. Oncology endpoint: overall survival and progression-free survival 13. Oncology endpoint: time to progression 14. Oncology endpoint: disease-free survival 15. Oncology endpoint: time to distant metastasis 16. Neoadjuvant therapy versus adjuvant therapy 17. Hematological cancers 18. Biomarkers and personalized medicine 19. Endpoints in immune diseases 20. Endpoints in clinical trials on infections 21. Health-related quality of life 22. Health-related quality of life instruments for immune disorders 23. Health-related quality of life instruments and Infections 24. Drug safety 25. Mechanism of action, Part I 26. Mechanism of Action, Part II: Cancer 27. Mechanism of Action, Part III: Immune Diseases 28. Mechanism of Action, Part IV: Infections 29. Consent Forms 30. Package Inserts 31. Regulatory Approval 32. Patents. Index
- Control code
- SD776639362
- Dimensions
- unknown
- Extent
- 1 online resource (xxxiii, 638 p.)
- Form of item
- online
- Isbn
- 9780123919137
- Isbn Type
- (ebk)
- Other physical details
- ill.
- Specific material designation
- remote
- Label
- Clinical trials : study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines, by Tom Brody, (electronic book)
- Bibliography note
- Includes bibliographical references and index
- Color
- multicolored
- Contents
- Introduction. Abbreviations and definitions. Biography. 1. The Origins of Drugs 2. Introduction to regulated clinical trials 3. Run-in Period 4. Inclusion/exclusion criteria, stratification, and subgroups, Part I 5. Inclusion and stratification criteria, Part II 6. Randomization, allocation, and blinding 7. Placebo arm as part of clinical study design 8. Intent to treat analysis vs. per protocol analysis 9. Biostatistics 10. Introduction to endpoints for clinical trials in pharmacology 11. Endpoints in clinical trials on solid tumors : objective response 12. Oncology endpoint: overall survival and progression-free survival 13. Oncology endpoint: time to progression 14. Oncology endpoint: disease-free survival 15. Oncology endpoint: time to distant metastasis 16. Neoadjuvant therapy versus adjuvant therapy 17. Hematological cancers 18. Biomarkers and personalized medicine 19. Endpoints in immune diseases 20. Endpoints in clinical trials on infections 21. Health-related quality of life 22. Health-related quality of life instruments for immune disorders 23. Health-related quality of life instruments and Infections 24. Drug safety 25. Mechanism of action, Part I 26. Mechanism of Action, Part II: Cancer 27. Mechanism of Action, Part III: Immune Diseases 28. Mechanism of Action, Part IV: Infections 29. Consent Forms 30. Package Inserts 31. Regulatory Approval 32. Patents. Index
- Control code
- SD776639362
- Dimensions
- unknown
- Extent
- 1 online resource (xxxiii, 638 p.)
- Form of item
- online
- Isbn
- 9780123919137
- Isbn Type
- (ebk)
- Other physical details
- ill.
- Specific material designation
- remote
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<div class="citation" vocab="http://schema.org/"><i class="fa fa-external-link-square fa-fw"></i> Data from <span resource="http://link.liverpool.ac.uk/portal/Clinical-trials--study-design-endpoints-and/zuvketeCIaE/" typeof="Book http://bibfra.me/vocab/lite/Item"><span property="name http://bibfra.me/vocab/lite/label"><a href="http://link.liverpool.ac.uk/portal/Clinical-trials--study-design-endpoints-and/zuvketeCIaE/">Clinical trials : study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines, by Tom Brody, (electronic book)</a></span> - <span property="potentialAction" typeOf="OrganizeAction"><span property="agent" typeof="LibrarySystem http://library.link/vocab/LibrarySystem" resource="http://link.liverpool.ac.uk/"><span property="name http://bibfra.me/vocab/lite/label"><a property="url" href="http://link.liverpool.ac.uk/">University of Liverpool</a></span></span></span></span></div>
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<div class="citation" vocab="http://schema.org/"><i class="fa fa-external-link-square fa-fw"></i> Data from <span resource="http://link.liverpool.ac.uk/portal/Clinical-trials--study-design-endpoints-and/zuvketeCIaE/" typeof="Book http://bibfra.me/vocab/lite/Item"><span property="name http://bibfra.me/vocab/lite/label"><a href="http://link.liverpool.ac.uk/portal/Clinical-trials--study-design-endpoints-and/zuvketeCIaE/">Clinical trials : study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines, by Tom Brody, (electronic book)</a></span> - <span property="potentialAction" typeOf="OrganizeAction"><span property="agent" typeof="LibrarySystem http://library.link/vocab/LibrarySystem" resource="http://link.liverpool.ac.uk/"><span property="name http://bibfra.me/vocab/lite/label"><a property="url" href="http://link.liverpool.ac.uk/">University of Liverpool</a></span></span></span></span></div>
