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

Autor:	Donald R. Ricci, Joost de Vries, Raphael Blanc
Jazyk:	angličtina
Rok vydání:	2017
Předmět:	Clinical trial intracranial bifurcation aneurysm health policy registry data medical device Public aspects of medicine RA1-1270 Business HF5001-6182
Zdroj:	Journal of Market Access & Health Policy, Vol 5, Iss 1 (2017)
Druh dokumentu:	article
ISSN:	2001-6689 20016689
DOI:	10.1080/20016689.2017.1283106
Popis:	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.
Databáze:	Directory of Open Access Journals
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