Study Conduct

Charges Filed in Case of Fabricated Study Results

Thursday, January 21, 2010 07:15 AM

Charges were filed in the case of Scott Reuben, the U.S. anesthesiologist who allegedly fabricated clinical trial data for at least 21 published articles. Reuben, who wrote about pain management after surgery, was formerly chief of acute pain at Bay State Hospital in Springfield, Mass.

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AAHRPP Changes Process, Awards Fewer Accreditations

Monday, December 28, 2009 08:30 AM

Organizations accredited by the Accreditation of Human Research Protection Programs (AAHRPP) will soon be able to go longer between accreditation renewals as part of a number of process changes effective January 1.  

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ICON Receives FDA Warning Letter

Wednesday, December 9, 2009 07:01 AM

Dublin contract research organization (CRO) ICON received a warning
letter from the U.S. Food and Drug Administration (FDA) related to the
management of two clinical studies conducted between 2004 and 2006.

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IQWiG Calls for Mandatory Clinical Trial Transparency in EU

Tuesday, December 8, 2009 01:06 PM

The Institute for Quality and Efficiency in Health Care (IQWiG) is calling on the German government to push for an EU regulation making it mandatory for sponsors to register and publish the results of all of their clinical trials, including negative ones. 

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University of Rochester Medical Center Creates Cardiac Safety Center

Wednesday, November 25, 2009 07:34 AM

The University of Rochester Medical Center announced the creation of a new center that will assist researchers studying the electrical activity of the heart with the goal of improving drug safety, understanding cardiac arrhythmias and developing new electrocardiograph technologies.

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Whistleblower Suit Filed Against Carle Foundation Hospital, Clinic Over Patient Protection

Thursday, November 19, 2009 08:28 AM

Charging that the Carle Foundation Hospital and Carle Clinic failed to protect cancer patients in their clinical trials, Suzanne Stratton, Ph.D, the former vice president for research at the Carle Foundation Hospital in Urbana, Ill., filed a whistleblower lawsuit in federal court against the hospital’s chief executive officer, the Carle Clinic Association, Kendrith Rowland, M.D., a lead physician at the Carle Clinic, and Bruce Wellman, M.D., the Carle Clinic CEO. 

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China Drug Agency Details Process Changes at ChinaTrials 2009

Tuesday, November 10, 2009 06:26 AM

At the ChinaTrials 2009 conference in Beijing Monday, Dr. Yi Feng, director of Review Management, Center for Drug Evaluation (CDE) in China, laid out plans to implement a new GRP process. GRP is an acronym representing three “R” practices: Good Review Practice, Good Regulatory Practice and Good Registration Practice. It is expected that implementing GRP will greatly contribute to shortening drug review timelines in China. 

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Metroplex Clinical Research Center, Rheumatology Associates Open New Site

Friday, November 6, 2009 07:29 AM

Dallas-based Metroplex Clinical Research Center (MCRC) and Rheumatology Associates have opened their new 22,500-square-foot complex featuring rheumatology services and phase I-IV research services under one roof.

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Schulman Associates IRB Expands into Canada

Tuesday, November 3, 2009 08:31 AM

Cincinnati-based Schulman Associates IRB has expanded its institutional review board (IRB) services into Canada. For North American studies, which are conducted in both the U.S. and Canada, Canadian and U.S. board members will review the research together to maintain consistency.

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Laboratorio Hidalgo Expands Central Lab in Buenos Aires

Wednesday, October 28, 2009 09:59 AM

Laboratorio Hidalgo, a central laboratory in Buenos Aires, Argentina, has increased its capacity for its clinical trials division with a new facility five minutes from its headquarters and laboratory.

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