Clinical trials and tribulations:
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| Main Authors: | , , |
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| Format: | Book |
| Language: | English |
| Published: |
San Diego
Elsevier
[2023]
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| Subjects: | |
| Online Access: | Inhaltsverzeichnis Klappentext |
| Physical Description: | ix, 265 Seiten |
| ISBN: | 9780128217870 |
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| adam_text | Contents Chapter 1 The clinical research landscapes............................................. 1 Gayathri De Lanerolle, Peter Phiri, Athar Haroon, and Heitor Cavalini 1.1 A brief history.......................................................................................... 1 1.2 The clinical research revolution...........................................................4 1.3 Modern-day clinical research ............................................................... 9 References................................................................................................... 10 Further reading............................................................................................ 11 Chapter 2 Clinical trials and epidemiology studies.................................. 13 Gayathri De Lanerolle, Peter Phiri, Athar Haroon, and Heitor Cavalinl 2.1 Background......................................................... 13 2.2 Clinical trials.......................................................................................... 18 2.3 Epidemiology........................................................................................31 2.4 Epidemiology methodology............................................................... 36 References.................................................................................................. 38 Chapter 3 Principles of medical statistics.................................................... 41 Gayathri De Lanerolle, Peter Phiri, Athar Haroon, Heitor Cava lini, and Jian Qing Shi 3.1
Introduction......................................................................................... 41 3.2 An overview of statisticalmethods..................................................... 44 3.3 Epidemiology statistics....................................................................... 60 3.4 Disease mapping methods.................................................................71 3.5 Clinical trial statistics........................................ 75 References.................................................................................................. 82 v
VÍ Contents Chapter 4 Research ethics and supporting evolving research............... 87 Gayathri De Lanerolle, Peter Phiri, Athar Haroon, and Heitor Cavalini 4.1 Introduction......................................................................................... 87 4.2 Morality versus ethics .......................................................................... 90 4.3 Evolving research ethics........................................................................ 93 References..................................................................................................... 95 Chapter 5 Primary and secondary care research........................................ 97 Gayathri De Lanerolle, Peter Phiri, Athar Haroon, and Heitor Cavalini 5.1 Introduction......................................................................................... 97 5.2 Evidence synthesis................................................................................ 99 References................................................................................................... 199 Further reading............................................................................................. 119 Chapter 6 Data science and clinical informatics...................................... Ш Gayathri De Lanerolle, Peter Phiri, Athar Haroon, Heitor Cavalini, and Jian Qing Shi 6.1 Introduction......................................................................................... 111 6.2 Clinical informatics.............................................................................. 114 6.3
Interoperability.....................................................................................119 6.4 Electronic healthrecords (EHRs)......................................................... 117 6.5 Healthcare data regulations andgovernance ................................... 130 6.6 Imaging data science.......................................................................... 131 6.7 Big data.................................................................................................141 References...................................................................................................148 Further reading............................................................................................ 152 Chapter 7 Organisational structure andresearch readiness................... 153 Gayathri De Lanerolle, Peter Phiri, Athar Haroon, and Heitor Cavalini 7.1 Introduction....................................................................................... 153 7.2 Structure and readiness for conducting research in the United Kingdom........................................................................ 158
Contents vii 7.3 Structure and readinessin academia versus the NHS..................... 161 References................................................................................................. 162 Further reading.......................................................................................... 163 Chapter 8 Researchcapacity and capability.............................................. 165 Gayathri De Lanerolle, Peter Phiri, Athar Haroon, and Heitor Cavalini 8.1 Background ........................................................................................ 165 8.2 Professional perspectives.................................................................. 165 8.3 Roles in clinical research .................................................................. 169 References................................................................................................. 178 Further reading.......................................................................................... 179 Chapter 9 Research waste............................................................................. 181 Gayathri De Lanerolle, Peter Phiri, Athar Haroon, and Heitor Cavalini 9.1 Background........................................................................................ 181 9.2 Addressing research waste................................................................ 182 References................................................................................................. 186 Chapter 10 Research operations management.......................................... 187 Gayathri De
Lanerolle, Peter Phiri, Athar Haroon, and Heitor Cavalini 10.1 Background......................................................................................187 10.2 Peer review...................................................................................... 198 10.3 Recruitment and retention of participants in clinical research.......................................................................... 200 10.4 Challenges in recruitment and retention..................................... 201 10.5 Contextual factors.......................................................................... 202 10.6 Participant factors.......................................................................... 202 10.7 Research factors............................................................................ 203 10.8 Strategies to improve recruitment and retention....................... 204 10.9 Participant-related barriers........................................................... 204 10.10 Monetary compensation............................................................... 205 10.11 Strategies to cultural and contextual barriers..............................206
viii Contents 10.12 Tackling research-relatedbarriers................................................... 207 10.13 Recruitment methods..................................................................... 207 10.14 Informed consent............................................................................ 208 10.15 Participant information sheet(PIS)................................................ 209 References.................................................................................................. 209 Further reading............................................................................................ 213 Chapter 11 Research governance and compliance management.... 215 Gayathri De Lanerolle, Peter Phiri, Athar Haroon, Heitor Cavalini, and Kathryn Elliot 11.1 Background......................................................................................... 215 11.2 Research governance ........................................................................ 216 11.3 Research compliance management................................................. 217 References.................................................................................................. 218 Further reading............................................................................................218 Chapter 12 Audits and inspections............................................................... 219 Gayathri De Lanerolle, Peter Phiri, Athar Haroon, and Heitor Cavalini 12.1 Background ....................................................................................... 219 12.2
Audits.................................................................................................. 223 12.3 Inspections......................................................................................... 230 References.................................................................................................. 231 Further reading............................................................................................ 232 Chapter 13 Patients and public support........................................................ 233 Gayathri De Lanerolle, Peter Phiri, Athar Haroon, and Heitor Cavalini 13.1 Background ....................................................................................... 233 13.2 Patient-public involvement (PPI)...................................................... 234 13.3 Barriers to patient-public involvement...........................................235 13.4 The future of patient—public involvement...................................... 237 References.................................................................................................. 238
Contents ІХ Chapter 14 Dissemination and implementation ........................................ 241 Gayathri De Lanerolle, Peter Phiri, Athar Haroon, and Heitor Cavalini 14.1 Background ....................................................................................................241 14.2 Dissemination science ..................................................................................242 14.3 Implementation science............................................................................... 249 References.................................................................................................................... 252 Chapter 15 The future of clinical research ............................................... 255 Gayathri De Lanerolle, Peter Phiri, Athar Haroon, and Heitor Cavalini 15.1 Background ..................................................................................................... 255 15.2 Use of existing evidence.............................................................................. 256 15.3 Effectively addressing barriers................................................................ 256 15.4 Maximising the digital landscape........................................................... 258 References.................................................................................................................... 258 Index............................................................................................................................. 259 Note from the authors: We would like to acknowledge Ms Sana Sajid for helping us
complete the administrative aspects of completing this book
Clinical Trials and Tribulations A comprehensive resource on clinical trials vilh extensive case studies and real-icorld examples Gayathri De Lanerolle, Peler Phiri, and Alhar Haroon Clinical Trials anil Tribulations evaluates the multiple lavers of complexities around clinical research management by way of exploring the sciences. It explores current practices and challenges as well as future directions of clinical trials and epidemiology studies. Il provides answers to readers questions and problems through extensive use of case studies and lessons learned, which is especially uselili for healthcare professionals. Follow ing an approach lo provide pragmatic view points as well as concepts and methodologies and ils alignment willi specific practices. Clinical Trials and Tribulations explores lhe paradigms between planning and conducting research in academia vs. healthcare vs. industry in (he IK. This book highlights practical solutions to real-world complex issues that have been documented by independent regulators lhal cover godd governance and maintaining compliance to changing legislations long term. ( linical Iriais and Tribulations will he an indispensable book for all staff working in clinical research within healthcare, academia, and industry, as well as students intending to work in clinical trials. Kev Features: • ( overs key topics across pre-clinical. clinical research and clinical practice • I lighlighls areas such as socio-economics of conducting research, capacity and capability, res. 6385333994399 performance (including performance indicators, adaptive
design, and practical solutions) • Provides lessons learned front breach of protocols, ethical breaches. SAE/SUSARs. aseptic pharmacy preparation issues and 1 ily 95596560994 wilhin research structures • Includes a focus on The UK clinical research system, offering key insights into w . J l:. ; wilhin the UK and collaborating with UK 8353336653955 partners
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Contents Chapter 1 The clinical research landscapes. 1 Gayathri De Lanerolle, Peter Phiri, Athar Haroon, and Heitor Cavalini 1.1 A brief history. 1 1.2 The 'clinical research' revolution.4 1.3 Modern-day clinical research . 9 References. 10 Further reading. 11 Chapter 2 Clinical trials and epidemiology studies. 13 Gayathri De Lanerolle, Peter Phiri, Athar Haroon, and Heitor Cavalinl 2.1 Background. 13 2.2 Clinical trials. 18 2.3 Epidemiology.31 2.4 Epidemiology methodology. 36 References. 38 Chapter 3 Principles of medical statistics. 41 Gayathri De Lanerolle, Peter Phiri, Athar Haroon, Heitor Cava lini, and Jian Qing Shi 3.1
Introduction. 41 3.2 An overview of statisticalmethods. 44 3.3 Epidemiology statistics. 60 3.4 Disease mapping methods.71 3.5 Clinical trial statistics. 75 References. 82 v
VÍ Contents Chapter 4 Research ethics and supporting evolving research. 87 Gayathri De Lanerolle, Peter Phiri, Athar Haroon, and Heitor Cavalini 4.1 Introduction. 87 4.2 Morality versus ethics . 90 4.3 Evolving research ethics. 93 References. 95 Chapter 5 Primary and secondary care research. 97 Gayathri De Lanerolle, Peter Phiri, Athar Haroon, and Heitor Cavalini 5.1 Introduction. 97 5.2 Evidence synthesis. 99 References. 199 Further reading. 119 Chapter 6 Data science and clinical informatics. Ш Gayathri De Lanerolle, Peter Phiri, Athar Haroon, Heitor Cavalini, and Jian Qing Shi 6.1 Introduction. 111 6.2 Clinical informatics. 114 6.3
Interoperability.119 6.4 Electronic healthrecords (EHRs). 117 6.5 Healthcare data regulations andgovernance . 130 6.6 Imaging data science. 131 6.7 Big data.141 References.148 Further reading. 152 Chapter 7 Organisational structure andresearch readiness. 153 Gayathri De Lanerolle, Peter Phiri, Athar Haroon, and Heitor Cavalini 7.1 Introduction. 153 7.2 Structure and readiness for conducting research in the United Kingdom. 158
Contents vii 7.3 Structure and readinessin academia versus the NHS. 161 References. 162 Further reading. 163 Chapter 8 Researchcapacity and capability. 165 Gayathri De Lanerolle, Peter Phiri, Athar Haroon, and Heitor Cavalini 8.1 Background . 165 8.2 Professional perspectives. 165 8.3 Roles in clinical research . 169 References. 178 Further reading. 179 Chapter 9 Research waste. 181 Gayathri De Lanerolle, Peter Phiri, Athar Haroon, and Heitor Cavalini 9.1 Background. 181 9.2 Addressing research waste. 182 References. 186 Chapter 10 Research operations management. 187 Gayathri De
Lanerolle, Peter Phiri, Athar Haroon, and Heitor Cavalini 10.1 Background.187 10.2 Peer review. 198 10.3 Recruitment and retention of participants in clinical research. 200 10.4 Challenges in recruitment and retention. 201 10.5 Contextual factors. 202 10.6 Participant factors. 202 10.7 Research factors. 203 10.8 Strategies to improve recruitment and retention. 204 10.9 Participant-related barriers. 204 10.10 Monetary compensation. 205 10.11 Strategies to cultural and contextual barriers.206
viii Contents 10.12 Tackling research-relatedbarriers. 207 10.13 Recruitment methods. 207 10.14 Informed consent. 208 10.15 Participant information sheet(PIS). 209 References. 209 Further reading. 213 Chapter 11 Research governance and compliance management. 215 Gayathri De Lanerolle, Peter Phiri, Athar Haroon, Heitor Cavalini, and Kathryn Elliot 11.1 Background. 215 11.2 Research governance . 216 11.3 Research compliance management. 217 References. 218 Further reading.218 Chapter 12 Audits and inspections. 219 Gayathri De Lanerolle, Peter Phiri, Athar Haroon, and Heitor Cavalini 12.1 Background . 219 12.2
Audits. 223 12.3 Inspections. 230 References. 231 Further reading. 232 Chapter 13 Patients and public support. 233 Gayathri De Lanerolle, Peter Phiri, Athar Haroon, and Heitor Cavalini 13.1 Background . 233 13.2 Patient-public involvement (PPI). 234 13.3 Barriers to patient-public involvement.235 13.4 The future of patient—public involvement. 237 References. 238
Contents ІХ Chapter 14 Dissemination and implementation . 241 Gayathri De Lanerolle, Peter Phiri, Athar Haroon, and Heitor Cavalini 14.1 Background .241 14.2 Dissemination science .242 14.3 Implementation science. 249 References. 252 Chapter 15 The future of clinical research . 255 Gayathri De Lanerolle, Peter Phiri, Athar Haroon, and Heitor Cavalini 15.1 Background . 255 15.2 Use of existing evidence. 256 15.3 Effectively addressing barriers. 256 15.4 Maximising the digital landscape. 258 References. 258 Index. 259 Note from the authors: We would like to acknowledge Ms Sana Sajid for helping us
complete the administrative aspects of completing this book
Clinical Trials and Tribulations A comprehensive resource on clinical trials vilh extensive case studies and real-icorld examples Gayathri De Lanerolle, Peler Phiri, and Alhar Haroon Clinical Trials anil Tribulations evaluates the multiple lavers of complexities around clinical research management by way of exploring the sciences. It explores current practices and challenges as well as future directions of clinical trials and epidemiology studies. Il provides answers to readers' questions and problems through extensive use of case studies and lessons learned, which is especially uselili for healthcare professionals. Follow ing an approach lo provide pragmatic view points as well as concepts and methodologies and ils alignment willi specific practices. Clinical Trials and Tribulations explores lhe paradigms between planning and conducting research in academia vs. healthcare vs. industry in (he IK. This book highlights practical solutions to real-world complex issues that have been documented by independent regulators lhal cover godd governance and maintaining compliance to changing legislations long term. ( linical Iriais and Tribulations will he an indispensable book for all staff working in clinical research within healthcare, academia, and industry, as well as students intending to work in clinical trials. Kev Features: • ( overs key topics across pre-clinical. clinical research and clinical practice • I lighlighls areas such as socio-economics of conducting research, capacity and capability, res. 6385333994399 performance (including performance indicators, adaptive
design, and practical solutions) • Provides lessons learned front breach of protocols, ethical breaches. SAE/SUSARs. aseptic pharmacy preparation issues and ' ' 1 "ily 95596560994 wilhin research structures • Includes a focus on The UK clinical research system, offering key insights into w . J l:. ; wilhin the UK and collaborating with UK 8353336653955 partners |
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