Article

An Outline for Public Registration of Clinical Trials Evaluating Medical Devices

Columbia University, New York, New York, United States
Journal of the American College of Cardiology (Impact Factor: 15.34). 05/2006; 47(8):1518-21. DOI: 10.1016/j.jacc.2005.09.079
Source: PubMed

ABSTRACT Public registration of clinical trials is fundamentally important to the integrity of the medical device development process. In addition to fulfilling obligations to those study volunteers, a complete record of trial results provides the general public, clinical community, and medical device manufacturers with a more accurate understanding as to how a specific therapeutic should be used. Although the issues associated with public disclosure of clinical trials are similar to the pharmaceutical industries, the iterative nature of device development introduces differences in what type of information needs to be disclosed during development and commercialization. The Second Dartmouth Device Development Symposium (3D2) held in October 2004 brought together thought leaders representing many of the stakeholders associated with medical device development. This consensus document arising from the proceedings of the 3D2 is offered to provide background to these issues and recommend pathways to implementation of device trial registration.

0 Followers
 · 
97 Views
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: The European Commission announced in 2008 that a fundamental revision of the medical device directives is being considered in order to clarify and strengthen the current legal framework. The system for testing and approving devices in Europe was established >20 years ago as a 'New Approach' to a previously little-regulated industry. It is recognized by many that the regulatory system has not kept pace with technological advances and changing patterns of medical practice. New legislation will be drafted during 2011, but medical experts have been little involved in this important process. This context makes it an opportune time for a professional association to advise from both clinical and academic perspectives about changes which should be made to improve the safety and efficacy of devices used in clinical practice and to develop more appropriate systems for their clinical evaluation and post-marketing surveillance. This report summarizes how medical devices are regulated and it reviews some serious clinical problems that have occurred with cardiovascular devices. Finally, it presents the main recommendations from a Policy Conference on the Clinical Evaluation of Cardiovascular Devices that was held at the European Heart House in January 2011.
    European Heart Journal 05/2011; 32(13):1673-86. DOI:10.1093/eurheartj/ehr171 · 14.72 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: The demand of transparency of clinical research results, the need of accelerating the process of transferring innovation in the daily medical practice as well as assuring patient safety and product efficacy make it necessary to extend the functionality of traditional trial registries. These new systems should combine different functionalities to track the information exchange, support collaborative work, manage regulatory documents and monitor the entire clinical investigation (CIV) lifecycle. This is the approach used to develop MEDIS, a Medical Device Information System, described in this paper under the perspective of the business process, and the underlining architecture. Moreover, MEDIS was designed on the basis of Health Level 7 (HL7) v.3 standards and methodology to make it interoperable with similar registries, but also to facilitate information exchange between different health information systems.
    01/2013; DOI:10.5121/ijcsit.2012.4602
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Unmet clinical needs remain the primary driving force for innovations in medical devices. While appropriate mechanisms to protect these innovative outcomes are essential, the performance of clinical trials to ensure safety is also mandated before the invention is ready for public use. Literature explaining the relationship between patenting activities and clinical trials of medical devices is scarce. Linking patent ownership to clinical trials may imply product leadership and value chain control. In this paper, we use patent data from Indian Patent Office (IPO), PCT, and data from Clinical Trials Registry of India (CTRI) to identify whether patent assignees have any role in leading as primary sponsors of clinical trials. A total of 42 primary sponsors are identified from the CTRI database in India. Number of patents awarded to these primary sponsors in the particular medical device, total number of patents awarded to the primary sponsor in all technologies, total number of patents in the specific medical device technology provides an indication of leadership and control in the value chain.
    PICMET, 2014 Portland International Conference on Management of Engineering & Technology, Kanazawa, Japan; 07/2014

Full-text (2 Sources)

Download
86 Downloads
Available from
Jun 3, 2014