Innovation in Clinical Trial Methodologies

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.

• 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

"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)