Re-Engineering Clinical Trials: Best Practices for Streamlining the Development Process
Editat de Peter Schueler, Brendan Buckleyen Limba Engleză Paperback – feb 2021
- Highlights the latest paradigm-shifts and innovation advances in clinical research
- Offers easy-to-find best practice sections, lists of current literature and resources for further reading and useful solutions to day-to-day problems in current drug development
- Discusses important topics such as safety profiling, data mining, site monitoring, change management, increasing development costs, key performance indicators and much more
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Specificații
ISBN-13: 9780128204894
ISBN-10: 0128204893
Pagini: 360
Ilustrații: Approx. 115 illustrations (65 in full color)
Dimensiuni: 152 x 229 mm
Ediția:2
Editura: ELSEVIER SCIENCE
ISBN-10: 0128204893
Pagini: 360
Ilustrații: Approx. 115 illustrations (65 in full color)
Dimensiuni: 152 x 229 mm
Ediția:2
Editura: ELSEVIER SCIENCE
Cuprins
Section
1:
Why
Does
the
Industry
Need
a
Change?1.
Why
is
our
industry
struggling?
2.
What
are
the
current
main
obstacles
to
reach
drug
approval?
3.
Japan:
An
opportunity
to
learn?
4.
The
"Clinical
Trial
App"
Section 2: What Does Our Industry and What Do Others Do5. What does "re-engineering" mean in our industry? 6. How can the Innovative Medicines Initiative help to make drug development more efficient? 7. Experiences with Lean and Shopfloor Management in R&D in other branches 8. Well-known methodologies, but not in our world: FMEA
Section 3: Where to Start: The Protocol9. No patients, no data: Patient recruitment in the 21st century 10. The impact of bad protocols 11. Data mining for better protocols 12. It is all in the literature 13. What makes a good protocol better? 14. The Clinical Trial Site
Section 4: Alternative Study Designs15. Do we need new endpoints? Surrogate and bio-marker 16. On the measurement of the disease status in clinical trials: lessons from MS 17. Generating evidence from historical data using “robust prognostic matching: Experience from Multiple Sclerosis 18. Studies with fewer patients involved: the Adaptive Trial 19. Studies with less site involvement: the Hyper Trial 20. Studies without sites: the Virtual Trial
Section 5: From Data to Decisions21. Data standards against data overload 22. Data management 2.0 23. What do Sites Want? 24. From data to information and decision: ICONIK 25. Knowledge Management 26. Taking Control of Ever Increasing Volumes of Unstructured Data 27. Share the Knowledge based on quality data
Section 6: You Need Processes, Systems and People28. It's all about the people (and their competencies) 29. Manage the Change 30. How Key Performance Indicators help to manage the change
Conclusions
Section 2: What Does Our Industry and What Do Others Do5. What does "re-engineering" mean in our industry? 6. How can the Innovative Medicines Initiative help to make drug development more efficient? 7. Experiences with Lean and Shopfloor Management in R&D in other branches 8. Well-known methodologies, but not in our world: FMEA
Section 3: Where to Start: The Protocol9. No patients, no data: Patient recruitment in the 21st century 10. The impact of bad protocols 11. Data mining for better protocols 12. It is all in the literature 13. What makes a good protocol better? 14. The Clinical Trial Site
Section 4: Alternative Study Designs15. Do we need new endpoints? Surrogate and bio-marker 16. On the measurement of the disease status in clinical trials: lessons from MS 17. Generating evidence from historical data using “robust prognostic matching: Experience from Multiple Sclerosis 18. Studies with fewer patients involved: the Adaptive Trial 19. Studies with less site involvement: the Hyper Trial 20. Studies without sites: the Virtual Trial
Section 5: From Data to Decisions21. Data standards against data overload 22. Data management 2.0 23. What do Sites Want? 24. From data to information and decision: ICONIK 25. Knowledge Management 26. Taking Control of Ever Increasing Volumes of Unstructured Data 27. Share the Knowledge based on quality data
Section 6: You Need Processes, Systems and People28. It's all about the people (and their competencies) 29. Manage the Change 30. How Key Performance Indicators help to manage the change
Conclusions
Recenzii
"...a good overview of problems facing the pharmaceutical industry in the design and conduct of clinical trials, especially within the current regulatory framework. Score: 74 - 3 Stars" --Doody's