November 2004 – The CenterWatch Monthly : Volume 11, Issue 11, November 2003

Canadian Clinical Trials Market Heats Up

In September 2001, amendments to regulations governing clinical research in Canada went into effect and have jump started clinical research there. Phase I trials have experienced the greatest growth and leap forward, with dramatically improved timelines for approval of CTAs, the equivalent of INDs in the U.S. Conditions already conducive to clinical research in the form of a currency exchange rate favorable to the U.S. and Western Europe and generous R&D tax credits as well as good data quality have combined with the regulatory changes to create an attractive business climate for industry-sponsored trials.

From CRC to CEO

Clinical research coordinators are the backbone of clinical research. Their work in the trenches, learning the many skills of running an investigative site, has served them, study subjects —and clinical research in general—well. Many have used these skills to move on and start their own companies in the clinical research niche, while along the way improving the process of drug development. Thomson CenterWatch tells the success stories of a number of enterprising CRCs who have started their own companies. They detail how they got started, their ups and downs, and offer advice on how other CRCs can follow in their footsteps.

Directive Shifts Phase I Work Away from U.K. Academic Sites

The EU Clinical Trials Directive’s effective date of May 1, 2004, marked the first time that healthy volunteer trials were regulated in the U.K.

Eye On: Melanoma

In the last 30 years, the incidence of melanoma has more than doubled in the U.S. CenterWatch has identified a pipeline of 28 drugs in development for melanoma.

• Month in Review
• In the Pipeline
• Opportunities Underway
• TrialWatch