Study Conduct

Phase I Complexity a Hot Topic at DIA 2008

Thursday, June 26, 2008

Attempting to gain early efficacy data and examining possible biomarkers in intent-to-treat patients in phase I trials has become more commonplace as sponsors attempt to fill their thinning pipelines. And the use of advanced medical imaging and other diagnostics—especially in cardiovascular and central nervous system studies—has pushed the envelope of what traditional phase I units have handled. In many ways, complexity and an increased need for specialized expertise in early phase research is forcing many smaller phase I organizations to improve their infrastructure and focus on particular disease areas.

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Chinese Regulators, Pharma Industry Address Ethics Committee Challenges

Wednesday, May 28, 2008

A workshop held recently in Beijing presented an overview of the current ethical considerations and procedures for effectively designing, conducting and registering clinical trials in China. A key focus was clarifying the working procedures and challenges for ethics committees, also called institutional review boards, in China.

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Magic Johnson—Celebrity Spokesperson for Minority Patient Recruitment?

Friday, April 18, 2008

Earvin “Magic” Johnson, NBA champion and chairman and chief executive officer of the Johnson Development Corp., came to IIR’s 17th Annual Partnerships with CROs in Las Vegas, Nevada, with a mission—to urge pharma to increase minority participation in clinical trials. But, he left, quite possibly, with an even bigger mission—to become a celebrity spokesperson for minority patient recruitment.

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EDICT Report Provides Road Map To Comprehensive Patient Enrollment

Monday, April 7, 2008

A much anticipated report published by Baylor College’s Eliminating Disparities in Clinical Trials [EDICT] project has provided a nine-step action plan for improving the policies surrounding the conduct of clinical trials. The EDICT project set out to create a series of policy proposals designed to help patient recruitment and retention in clinical trials. The four-year project is supported by an unrestricted grant from Genentech.

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Negative or Positive Trial Results?

Thursday, January 17, 2008

There’s some great quotes in the Wall Street Journal’s story about the New England Journal of Medicine’s assertion that effectiveness of antidepressants has been exaggerated by selective publication of positive clinical trial results.

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