February 2005 – The CenterWatch Monthly : PDF
CROs, EDC Companies Partnering for eClinical Trials Adoption
Despite the benefits of implementing eClinical trials, including reduced costs for pharmaceutical sponsors, many CROs have resisted transforming from traditional paper-based clinical trials to electronic environments. In particular, CROs whose main business involves managing clinical trials are not anxious to switch to a process that could require fewer monitors and less billable hours. Some CROs have seen EDC vendors as competitive threats.
Zeroing in on Microdosing
Industry observers expect the number of microdose studies, also called human phase 0 trials, to increase in the United States once the U.S. Food and Drug Administration this month issues a draft guidance that will ease preclinical safety data requirements for microdose studies, making it easier to conduct them as exploratory studies rather than traditional phase I programs. During the past year, acceptance of microdose studies has grown more quickly in Europe. The growth of phase 0 could cut into the rapid rise of phase I trials, which sponsors have also used to kill drug candidates earlier.
WHO Prescribes Research and Pricing Policies for Europe
Europe should offer more public support and strong incentives for industry to do clinical research in areas overlooked by market forces, according to a new report from the World Health Organization (WHO).
Eye on: Parkinson’s Disease
Parkinson’s Disease affects more than 500,000 Americans. CenterWatch has identified a pipeline of 23 drugs in development for Parkinson’s.