Trends in Early Phase Clinical Research and how you can be ready for them, Dr Willem Jan Drijfhout
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Presented at Foundry Health's eSource meeting in Chicago, 03-Oct-2017
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Trends in Early Phase Clinical Research and how you can be ready for them, Dr Willem Jan Drijfhout
- 1. Trends in Early Phase Clinical Research and how you can be ready for them Willem Jan Drijfhout wjdrijfhout@me.com
- 2. Content • The Phase I challenge • Away with transcription • More sites is better • Patients first
- 3. Content • The Phase I challenge • Away with transcription • More sites is better • Patients first
- 4. 1 2a 2b 3 Clinical Development Phase ‘Phase I’ Studies First-in-man to Proof of Concept Clinical Pharmacology package Generics 4 Right-time delivery of data to make decisions for drug development
- 5. First-in-man to Proof of Concept Clinical Pharmacology package Generics Size Design complexity # Data Sources Changes Planning variability
- 7. Content • The Phase I challenge • Away with transcription • More sites is better • Patients first
- 8. Sponsor Investigator • Check • Monitor • Verify • Ensure • Inform • Complete • Obtain • Conduct • Demonstrate • Provide ManagementConduct
- 13. Challenges • Pluriformity • Fit for ‘work floor’ • Quality • Spend • Logistics • Disruptive (e)CRF = (e)Source
- 14. Opportunities • Increase quality of data • Increase safety patients • Shorten development timeline • Reduce development costs • Disruptive
- 16. Content • The Phase I challenge • Away with transcription • More sites is better • Patients first
- 17. 1 2a 2b 3 Clinical Development Phase ‘Phase I’ Studies First-in-man to Proof of Concept Clinical Pharmacology package Generics 4
- 18. ‘Phase I’ Studies First-in-man to Proof of Concept Increased inclusion of patients • Early signs of efficacy - Proof of Concept • Toxicity/tolerability unacceptable to healthy volunteers • Monoclonal antibodies • On-target safety cannot be studied in healthy volunteers • Pharmacokinetics in healthy volunteers not predictive for patients • Perceived time-gain by starting patients early
- 19. How to manage?
- 21. Content • The Phase I challenge • Away with transcription • More sites is better • Patients first
- 23. Communication
- 25. Site-less trials
- 27. Simple eSource/CRF solutions Patient Centric eSource/CRF solutions Integrated eSource/CRF solutions Failed eSource/CRF solutions Now Future
- 28. Data Real-time Analytics Safety Design-choices Management Syst. Integration Resources Timelines Training Quality Standardisation Automation Processes Less errors Small-scale Controlled environment Repetitive Why Phase I….
- 29. The Technology Revolution in Clinical Development is still to begin
- 30. Thank You