Article 385: 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.

Article 386: 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.

Article 387: 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.

Article 388: 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.