Description
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.- Considers multiple digital and virtual strategies- Explores best practices, including the use of reduced patient involvement- Brings together expert, trusted information to increase the efficiency and effectiveness of clinical trials
Table of Contents
Section 1 Introduction1. Is the Covid pandemic an accelerator for digitalization?2. Best practices for streamlined developmentSection 2 Alternative study concepts requiring fewer patients3. Use of historic data4. Adaptive and platform trials5. A vision: Studies without patientsSection 3 Studies with less patient interaction6. Home Nursing replacing site visits7. Telemedicine replacing site visitsSection 4 Design of "virtualized" protocols8. Data mining for better protocols9. Patient-centric registries for population enrichment10. Make a protocol "patient centric"11. The use of new digital endpoints12. Regulations for apps in clinical trials13. The role of the site and the patient14. A real virtual trialSection 5 From data to decisions15. Data standards against data overload16. Data analytics for operational excellence17. Taking control of high data volume18. Share the (digital) knowledge based on quality dataSection 6 Conclusions
