Follow us on




Q of the week

Q: How Do You Get Shingles?

Get the Answer: 

Crohn's disease

Crohn's disease is an ongoing condition that causes inflammation of the digestive tract, or the GI (gastrointestinal) tract (the gut).

 Forums
Welcome Guest   [Register]  [Login]
EFGCP–EUCROF Joint Workshop Final Report   by  on 2010-08-20 20:12:20
Managing Clinical Trials   by  on 2010-07-16 00:05:32
US-FDA issues Revised Info Sheet Guidance on Clinical Investigator Disqualification   by  on 2010-06-13 18:11:41
US-FDA issues final guidance on Statement of Investigator (Form FDA 1572)   by  on 2010-06-13 18:07:59
Rising Clinical Trial Complexity Continues to Vex Drug Developers   by  on 2010-06-03 17:36:33
Investigator-Driven Clinical Trials: An ESF Forward Look   by  on 2010-06-03 17:27:58
NIH's Financial Conflict of Interest (FCOI) Proposed Rule   by  on 2010-05-27 19:42:00
AAP’s Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Population   by  on 2010-05-13 19:39:54
Argentina: ANMAT - new regulatory update   by  on 2010-05-01 09:40:32
The Wall Street Journal's special supplement on clinical trials   by  on 2010-05-01 09:31:52
Major developments in EU Clinical Trial Guidances   by  on 2010-04-21 03:10:55
Analysis of the adverse reactions induced by natural product-derived drugs   by  on 2010-04-19 07:16:06
Newer Antibacterial Drugs for a New Century   by  on 2010-04-19 06:49:47
Newer Non-Statin Drugs for Reducing Cholesterol   by  on 2010-04-13 15:57:20
Practice Guidelines for Chronic Pain Management   by  on 2010-04-05 04:52:16
CONSORT III (2010)   by  on 2010-03-29 20:53:28
US FDA Draft Guidance on Pharmacokinetics in Patients with Impaired Renal Function   by  on 2010-03-20 20:25:16
US-FDA issues First Draft Guidance on Noninferiority Trials   by  on 2010-03-04 22:07:46
US FDA new rule on reporting information regarding falsification of data   by  on 2010-02-26 04:47:33
US-FDA Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials   by  on 2010-02-06 20:12:14
 Subject :ASE Expert Consensus Statement: Echocardiographic Imaging in Clinical .. 2009-12-18 04:11:05 
GCP HelpDesk
Moderator
Joined: 2009-06-18 15:31:58
Posts: 62
Location
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,

IP Logged
GCP HelpDesk
Page # 


Powered by ccBoard