Peter Schueler
Innovation in Clinical Trial Methodologies
Lessons Learned during the Corona Pandemic
Paperback Engels 2020 9780128244906Levertijd ongeveer 9 werkdagen
Gratis verzonden
Samenvatting
Innovation in Clinical Trial Methodologies: Lessons Learned during the Corona Pandemic presents a selection of updated chapters from Re-Engineering Clinical Trials that feature innovative options and methods in clinical trials. The Coronavirus pandemic is an accelerator for digitalization in many industries, including clinical trials. This book considers best practices, alternative study concepts requiring fewer patients, studies with less patient interaction, the design of "virtualized" protocols, and moving from data to decisions. This book will be helpful to pharmacologists, physicians and clinical researchers involved in the process of clinical development and clinical trial design.
Specificaties
Lezersrecensies
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Inhoudsopgave
Section 1 Introduction
1. Is the Covid pandemic an accelerator for digitalization?
2. Best practices for streamlined development
Section 2 Alternative study concepts requiring fewer patients
3. Use of historic data
4. Adaptive and platform trials
5. A vision: Studies without patients
Section 3 Studies with less patient interaction
6. Home Nursing replacing site visits
7. Telemedicine replacing site visits
Section 4 Design of "virtualized" protocols
8. Data mining for better protocols
9. Patient-centric registries for population enrichment
10. Make a protocol "patient centric"
11. The use of new digital endpoints
12. Regulations for apps in clinical trials
13. The role of the site and the patient
14. A real virtual trial
Section 5 From data to decisions
15. Data standards against data overload
16. Data analytics for operational excellence
17. Taking control of high data volume
18. Share the (digital) knowledge based on quality data
Section 6 Conclusions
1. Is the Covid pandemic an accelerator for digitalization?
2. Best practices for streamlined development
Section 2 Alternative study concepts requiring fewer patients
3. Use of historic data
4. Adaptive and platform trials
5. A vision: Studies without patients
Section 3 Studies with less patient interaction
6. Home Nursing replacing site visits
7. Telemedicine replacing site visits
Section 4 Design of "virtualized" protocols
8. Data mining for better protocols
9. Patient-centric registries for population enrichment
10. Make a protocol "patient centric"
11. The use of new digital endpoints
12. Regulations for apps in clinical trials
13. The role of the site and the patient
14. A real virtual trial
Section 5 From data to decisions
15. Data standards against data overload
16. Data analytics for operational excellence
17. Taking control of high data volume
18. Share the (digital) knowledge based on quality data
Section 6 Conclusions
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