Innovation in clinical trial methodologies
Lessons learned during the corona pandemic
The Coronavirus pandemic is an accelerator for digitalisation in many industries
In a timely new book edited by Dr Peter Schueler, Senior VP Drug Development Services, Neurosciences, at ICON plc, authors explore how, by learning the right lessons, the industry and wider society could be entering a golden age of drug development.
The Coronavirus pandemic is an accelerator for digitalisation in many industries, including clinical trials. Presenting a selection of completely updated chapters from Re-Engineering Clinical Trials that feature innovative options and methods in clinical trials, the book is a concise, necessary investigation on best practices, alternative study concepts requiring fewer patients, studies with less patient interaction, the design of "virtualised" protocols, and moving from data to decisions.
Pharmacologists, physicians and clinical researchers involved in the process of clinical development and clinical trial design will all find this an essential resource.
Book
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Innovation in clinical trial methodologies
Dr Peter Schueler chats to Applied Clinical Trials on how CROs have changed over the years, his role in editing the 'Innovation in Clinical Trial Methodologies' book, and risk aversion versus innovation in the life sciences industry.
Table of contents
Section 1 Introduction
1. Is the Covid pandemic an accelerator for digitalisation?
2. Best practices for streamlined development
Section 2 Alternative study concepts requiring less 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