EDITORS:
- Stacey J. Ackerman, MSE, PhD,
Vice President,
Covance Market Access Services Inc.,
San Diego, CA
- Marilyn Dix Smith BSPharm, PhD, Executive Director, International Society for Pharmacoeconomics and Outcomes Research, Lawrenceville, NJ, USA
- Jenifer Ehreth MHA, PhD, Principal, International Market Access, Paris, France and Adjunct Professor, University of Lausanne, Health Economic Institute, Lausanne, Switzerland
- Randa Eldessouki MBBCh, MSc, MD, Director, ISPOR Scientific Initiatives, ISPOR, Lawrenceville, NJ, USA; Lecturer, Faculty of Medicine, Fayoum University, Fayoum, Egypt
- Erin Sullivan MPH, PhD, Vice President, Health Economics & Outcomes Research, Avalere Health LLC, Washington DC USA
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An outcomes research primer for those in the therapeutic and diagnostic device field with the purpose to inform:
- Health outcomes researchers on the unique characteristics of therapeutic and diagnostic devices, and
- Medical device developers and researchers on the basic principles of clinical, economic, and patient-reported outcomes research for therapeutic and diagnostic devices
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Table of Contents |
| Part 1: |
Introduction |
| Part 2: |
Research and Development |
| Part 3: |
Regulatory Requirements in USA & Europe |
| Part 4: |
Clinical Outcomes Research |
| Part 5: |
Therapeutic Device Clinical Outcomes Research
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| Part 6: |
Diagnostic Device Clinical Outcomes Research
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| Part 7: |
Drug-Device Combination Research
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| Part 8: |
Economic Evaluations |
| Part 9: |
Patient-Reported Outcomes Research
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| Part 10: |
Evidence Development and Reimbursement |
| Book Prices |
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- Regular price: $80.00
- ISPOR member discounted price: $40.00 (a 50% discount)
- North American Spine Society members discounted price: $40.00 (a 50% discount)
- Student/Library/Academic discounted price: $40.00 (a 50% discount)
- Pay by credit card, check, money order, traveler's check, bank transfer
- Receipt and invoice generation for
reimbursement
ISPOR Members may purchase ONE book at Member price. Any additional books will be at regular price. |
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“During my tenure in the medical device industry, the evolution of successfully entering the market has been eclipsed by patient access challenges encountered. Whether challenges come during regulatory body reviews or through barriers to patient access in the post-launch market, it is apparent the historical approach to reimbursement is no longer effective. The need for medical device manufacturers to demonstrate improvements in actual patient outcomes and clinical delivery in addition to improved safety and performance have become great game-changers. To succeed in this new market environment, accelerating the knowledge base of how to utilize economic modeling to ensure we are delivering clinically relevant and cost effective therapies is essential.
The comprehensive information in this books provides an invaluable resource ...one that has not been readily available. I'm sure it will become a standard reference tool as the economics of healthcare continue to develop”
Diana L. Bogard
VP Evidence Development, Medical Education & HCE
COVIDIEN Respiratory & Monitoring Solutions
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