Innovation in Clinical Trial Methodologies

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.

Autorentext
Peter Schüler is Senior Vice President, Global Medical & Safety Services, ICON Plc. Peter is board certified in neurology (1996; German Medical Board) and in Pharmaceutical Medicine (2001; Swiss Medical Association). In 1999 in obtained a Certificate in Business Administration by Henley Management College, UK. After his medical education he started is professional career in 1987 at the Medical Imaging Application Center of Siemens AG Medical Solutions. The same year he started at the Department of Experimental Neuropsychiatry of the Neurological University Hospital Erlangen, Germany. During the coming 8 years he was involved in basic and clinical CNS research. He held the position of Secretary General of the German section of the International League Against Epilepsy (ILAE; 1991-1995) and was awarded two scientific awards (Alfred-Hauptman epilepsy prize and ILAE Young Investigator Award). In 1995 he joined Pharmacia. During that period, he participated in the launch of two NCEs in the indications Parkinson's and major depression. In October 2000 he moved into the CRO business, building a department for Medical Affairs and also taking over responsibilities for clinical operations in Germany, Austria and Switzerland. In 2007, Peter joined ICON, now overseeing over 360 people located in 11 major offices in Argentina, Brazil, Germany, India, Japan, Latvia, Mexico, Poland, Singapore, UK and US. He issued several publications on drug safety and authored an eBook about clinical trial design and conduct (Zenosis Ltd publisher) and continues to lecture Pharmaceutical Medicine at the Universities of Duisburg-Essen, Germany and Aveiro, Portugal.

Inhalt

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

8. Patient-centric registries for population enrichment
9. Make a protocol "patient centric"
10. The use of new digital endpoints
11. Regulations for apps in clinical trials
12. The role of the site and the patient

13. A real virtual trial

    Section 5 From data to decisions

14. Data standards against data overload
15. Data analytics for operational excellence
16. Taking control of high data volume

17. Share the (digital) knowledge based on quality data

    Section 6 Conclusions