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: 16.5). 05/2006; 47(8):1518-21. DOI: 10.1016/j.jacc.2005.09.079
Source: PubMed


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.

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    • "Whilst the R&D stage poses uncertainty and risk to R&D investors, a similar situation is also seen with clinical trials. The "clinical trial" stage is very crucial and poses greater financial risk for developers of a new device [11] [19] [16]. Often, the clinical trial stage is referred to as a "road block" as it requires many regulatory hurdles to pass through depending on the risk of the medical device. "
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    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.
    Full-text · Conference Paper · Jul 2014
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    • "The demand for diffusing information on clinical studies already emerged in the mid '80s [15] [16], underlining the need to overcome " publication bias " related to trials never published or published in sources difficult to access. In particular, attention was focused on the tendency not to publish trials with negative results, whose diffusion would enhance research transparency and also contribute to knowledge advancement [17] [18]. Since then, different organizations have advocated mandatory submission of trial information [19] and a variety of trial registries have been developed [20] [21] [22] [23] [24]. "
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    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.
    Full-text · Article · Jan 2013
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    • "This marketing approach has allowed smaller companies to succeed even if they lack the ability to run large randomized trials. However, as payers increasingly look for evidence of efficacy to support coverage decisions, the demand for clinical trials on devices is increasing,9 and therefore also the relevance of trial registration to the device industry.5 "
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    ABSTRACT: Recently, several pharmaceutical companies have been shown to have withheld negative clinical trial results from the public. These incidents have resulted in a concerted global effort to register all trials at inception, so that all subsequent results can be tracked regardless of whether they are positive or negative. These trial registration policies have been driven in large part by concern about the pharmaceutical sector. The medical device industry is much smaller, and different from the pharmaceutical industry in some fundamental ways. This paper examines the issues surrounding registration of device trials and argues that these differences with pharmaceutical should not exempt device trials from registration.
    Full-text · Article · Feb 2008 · Journal of General Internal Medicine
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