Article 397: 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.

Article 398: 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human phase 0 trials, to increase in the United States once the U.S. Food and Drug Administration this month issues a draft guidance that will ease preclinical safety data requirements for microdose studies, making it easier to conduct them as exploratory studies rather than traditional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.

Article 399: 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).

Article 400: 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.