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Volume 5
Issue 1
10.1080/20016689.2017.1283106
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Journal of Market Access & Health Policy (JMAHP) is published by MDPI from Volume 12 Issue 1 (2024). Previous articles were published by another publisher in Open Access under a CC-BY (or CC-BY-NC-ND) licence, and they are hosted by MDPI on mdpi.com as a courtesy and upon agreement with Taylor & Francis.
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Background:
Communication

Role of Preliminary Registry Data in Development of a Clinical Trial for an Innovative Device: A Small but Integral Piece of a Health Policy Initiative

by
Donald R. Ricci
1,2,*,
Joost de Vries
3 and
Raphael Blanc
4
1
Division of Cardiology, University of British Columbia, Vancouver, BC, Canada
2
Evasc Medical Systems Corporation, Vancouver, BC, Canada
3
Department of Neurosurgery, Radboud University Nijmegen, Nijmegen, The Netherlands
4
Assistant Chief of Interventional Radiology, Ophthalmological Foundation A. de Rothschild, Paris, France
*
Author to whom correspondence should be addressed.
J. Mark. Access Health Policy 2017, 5(1), 1283106; https://doi.org/10.1080/20016689.2017.1283106
Submission received: 13 December 2016 / Revised: 15 December 2016 / Accepted: 20 December 2016 / Published: 2 March 2017

Abstract

Establishing a national health policy at a macro level involves the integration of a series of health initiatives across a spectrum of activities, including clinical care. Evaluation of the safety and efficacy of a new medical device ultimately evolves to testing in humans. The pathway to a formal prospective clinical trial includes a stepwise appreciation of pre-clinical data and detailed analysis of data obtained from preliminary registries, where information about appropriate patient selection and use of the device is obtained. Evaluation of procedural and follow-up efficacy and safety data in a preliminary series of cases, chosen to simulate published data, allows the design and conduct of clinical trials that are required to verify preliminary observations, closing the loop on one aspect of modifying health policy decisions.
Keywords: clinical trial; intracranial bifurcation aneurysm; health policy; registry data; medical device clinical trial; intracranial bifurcation aneurysm; health policy; registry data; medical device

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MDPI and ACS Style

Ricci, D.R.; de Vries, J.; Blanc, R. Role of Preliminary Registry Data in Development of a Clinical Trial for an Innovative Device: A Small but Integral Piece of a Health Policy Initiative. J. Mark. Access Health Policy 2017, 5, 1283106. https://doi.org/10.1080/20016689.2017.1283106

AMA Style

Ricci DR, de Vries J, Blanc R. Role of Preliminary Registry Data in Development of a Clinical Trial for an Innovative Device: A Small but Integral Piece of a Health Policy Initiative. Journal of Market Access & Health Policy. 2017; 5(1):1283106. https://doi.org/10.1080/20016689.2017.1283106

Chicago/Turabian Style

Ricci, Donald R., Joost de Vries, and Raphael Blanc. 2017. "Role of Preliminary Registry Data in Development of a Clinical Trial for an Innovative Device: A Small but Integral Piece of a Health Policy Initiative" Journal of Market Access & Health Policy 5, no. 1: 1283106. https://doi.org/10.1080/20016689.2017.1283106

APA Style

Ricci, D. R., de Vries, J., & Blanc, R. (2017). Role of Preliminary Registry Data in Development of a Clinical Trial for an Innovative Device: A Small but Integral Piece of a Health Policy Initiative. Journal of Market Access & Health Policy, 5(1), 1283106. https://doi.org/10.1080/20016689.2017.1283106

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