CenterWatch Monthly: December 2006 Issue
Increasing Minority Participation in Clinical Trials
Ensuring that clinical trial participation reflects the racial and ethnic makeup of the U.S. population and the epidemiology of the particular diseases being studied is becoming more of a priority for industry, government and academia. The barriers—while not insuperable—are numerous. Over-coming them will take a multi-pronged approach. One four-year research program undertaken last year by the Chronic Disease Prevention and Control Research Center at Baylor College of Medicine and the Intercultural Cancer Council and funded by Genentech is attempting to tackle the issue of increasing participation by underrepresented populations, including racial and ethnic minorities.
CROs Taking Tentative Steps Toward Reform
CROs have a big opportunity to help lead any changes in the drug development process in the wake of two high profile patient safety issues involving CROs in the past year. Despite the run of bad publicity, CROs seemed to have weathered the storm with strong revenues gains and share prices. But the CRO industry isn’t about to become complacent as it takes steps to carve out a leadership role in any reform efforts.
Mandatory GCP Certification in The Netherlands?
Nearly two years past the deadline, The Netherlands passed the EU Clinical Trial Directive into national law in March. Some are wasting no time in attempting to make certification in Good Clinical Practice (GCP) mandatory for clinical researchers who want to conduct a study in The Netherlands. It is a trend that could well gain traction throughout the EU.
Eye On: Skin Conditions
The skin is the largest and most exposed organ of the body, and, not surprisingly, it is prone to a variety of diseases. Hand dermatitis, or hand eczema, popularized in television commercials as “dishpan hands,” is one of the most common work-related diseases, affecting 5% to 10% of the population. It is characterized by hand rash, redness, dryness, cracking and inflammation.
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