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CWWeekly March 27th 2008 Issue

Friday, May 30, 2008 03:11 PM

Top News

NIH Program to Study Patients with Mystery Diseases

For thousands of frustrated patients with diseases that cannot be explained or diagnosed—even by leading specialists in their field—enrollment in clinical trials has not been an option. Without a definitive diagnosis, they are ineligible to participate. Now, through a pioneering program launched by the National Institutes of Health (NIH), there may be hope. The new trans-NIH initiative, called the Undiagnosed Disease Program, will concentrate its research efforts on patients who suffer from unknown, thus unstudied, illnesses.

CDER’s Woodcock Details Expanded Authority, Sentinel Concept at Post-Approval Summit

Opening the Post-Approval Summit at Harvard, keynote speaker Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), outlined her agency’s expanded authorities in the area of post-approval research oversight brought about by the passage of the FDA Amendments Act (FDAAA) into law at the end of March.

Other breaking news...

Pharm-Olam opens new office in Russia...
ClinPhone establishes new office in Paris...

Company Profile: An interview with Steve Toon, Ph.D., executive director, Simcyp

To read the full articles for this issue or for more information on these and other breaking stories, please click here for subscription information.

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CWWeekly

September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

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The CenterWatch Monthly

October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

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The CenterWatch Monthly

September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

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