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Innovation in Clinical Trial Methodologies
Lessons Learned during the Corona Pandemic
Explores the most innovative options and digital strategies available for conducting quality clinical trials in limited time
Peter Schueler (Edited by)
9780128244906, Elsevier Science
Paperback, published 6 November 2020
202 pages, 40 illustrations (20 in full color)
23.4 x 19 x 1.4 cm, 0.43 kg
"Much has been written on the correlation between crises and innovation. Our hope is that the COVID-19 crisis catalyzes enduring changes to clinical trial methodologies, ones that serve patients today and for years to come. Peter Schüler has created a timely textbook for all involved in the critical processes of clinical trial conduct. He has brilliantly set the stage for a possible dramatic evolution of clinical trial strategy, methodology, conduct, and interpretation; this evolution will be essential to address patients’ needs not just now during the pandemic but will endure and be applied broadly to many other diseases and therapies." --Barbara Lopez Kunz, President and Global Chief Executive, DIA (Drug Information Association)
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.
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
Subject Areas: Virology [non-medical PSGL], Pharmacology [MMG], Clinical trials [MBGR1]
