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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.
ARTICLE HISTORY
Received 13 December 2016
Revised 15 December 2016
Accepted 20 December 2016
KEYWORDS
Clinical trial; intracranial bifurcation aneurysm; health policy; registry data; medical device
Introduction
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. The World Health Organization's statement is that 'outcomes can be improved through increased and more focused investment in monitoring and evaluating how national health policies, strategies, and plans are implemented ... when properly designed, this allows for learning, continuous improvement of the planning process and timely corrective measures. It also contributes to documenting policy reform processes.'[1] One of these activities is the conduct of a clinical trial designed to determine utility of a new drug or device in the management schema of a disease entity.
Evaluation of the safety and efficacy of a new medical device begins with intensive pre-clinical ('bench' and animal) testing but must, at some stage, evolve to testing in humans who suffer from the disease entity that the device was designed to treat. This should occur cautiously and deliberately by highly experienced and skillful clinicians familiar with the disease entity, the device, the clinical milieu and the conduct of clinical trials. The purpose of this brief communication is to describe the rationale used to initiate a formal prospective clinical trial of an innovative device, eCLIPs (eVasc Neurovascular Enterprises ULC, eVasc Medical Systems Corp, Vancouver, Canada), using data from an ad...