CenterWatch Monthly: September 2007 Issue

Monday, September 17, 2007 11:36 AM

Fraudulent Study Broker At-Large: Cherie Thibodeau

Cherie Thibodeau has posed as a study broker for the past six years, in between her three stints in California State Prison. Working under numerous aliases and nine Social Security numbers, she has bilked numerous investigative sites out of potentially hundreds of thousands of dollars. Cherie Thibodeau has preyed on new and experienced sites alike. Other sites that have not yet fallen victim to her study brokering scam need to learn the warning signs for a dishonest broker. Investigative sites can avoid working with Thibodeau and her ilk.

Abigail Alliance Heading to Supreme Court

Abigail Alliance for Better Access to Developmental Drugs lost its lawsuit against the FDA last month in the U.S. Court of Appeals for the D.C. Circuit. The alliance took the FDA to court to establish that terminally ill patients in this country have a Constitutional right to have access to experimental drugs after phase I. Abigail Alliance now plans to argue its case before the Supreme Court of the United States. Some industry observers believe that if the alliance wins, it will undermine the drug development process by making clinical trials in terminal ill-nesses impossible to recruit for. Although Abigail Alliance lost its latest suit, the organization has had a marked effect on the FDA's expanded access program.

Affymetrix Launches Collaborations in Cancer Research Program in Europe

Affymetrix has partnered with about 30 leading scientists from European cancer institutes, research centers and universities, from countries including Denmark, Finland, Germany, Italy, Spain, The Netherlands and UK, as part of its collaborations in Cancer Research Program. The alliance will mean that Affymetrix will partially fund select research projects.

Eye On: Diabetes

Nearly 21 million Americans have diabetes and about 41 million have pre-diabetes, according to data from the Centers for Disease Control and Prevention (CDC). About 90-95% of patients with diabetes have type 2 diabetes, with increased attendant risk of cardiovascular disease, stroke, high blood pressure, limb amputation, blindness, neuropathy damage and kidney failure. CenterWatch has identified a pipeline of 16 different drugs in various stages of development for diabetes treatment. Some of these are new insulin formulations, and others act via different mechanisms to lower blood glucose.

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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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