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Q: Do clinical trials ever go wrong?

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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

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 Subject :ASE Expert Consensus Statement: Echocardiographic Imaging in Clinical .. 2009-12-17 20:11:05 
GCP HelpDesk
Joined: 2009-06-18 15:31:58
Posts: 62
Subject :ASE Expert Consensus Statement: Echocardiographic Imaging in Clinical Trials

Dear All,

Imaging with cardiac ultrasound is a critical element of cardiovascular clinical research. The noninvasive assessment of cardiac structure, function, and hemodynamics using echocardiography can provide essential data on the safety and efficacy of drugs and devices, as well as insight into mechanisms of disease and therapeutic benefit. Echocardiography may also be used to assess enrollment eligibility, provide surrogate endpoints, suggest future research directions, and assist in determining optimal patterns of clinical surveillance. However, the value of this information is highly dependent on the quality of the planning and performance of imaging, the quality of data analysis, and the appropriate incorporation of results into overall trial analysis.  A previous ASE document, "Recommendations for Use of Echocardiography in Clinical Trials," describes the importance of high-quality imaging for research. It recommends methods for some of the common applications of echocardiography, such as determinations of left ventricular ejection fraction and mass, but it does not extensively address the roles and responsibilities of core laboratories or other issues such as personnel, study design, imaging review charters, site management, information technology, and statistical analysis. No other document or guidelines statement exists to fill these gaps. Thus, there is a great need for a clear and universally accepted set of "best practices" in these areas, which form the core of this consensus-driven standards document. 

Click here for this ASE Expert Consensus Statement on Echocardiographic Imaging in Clinical Trials: American Society of Echocardiography Standards for Echocardiography Core Laboratories: Endorsed by the American College of Cardiology Foundation.

Kind regards,

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