China Ushers In New Era of Innovation
China's State Food and Drug Administration has implemented regulatory reforms and invested in domestic pharma to foster an innovative drug development community. Some of the reforms are also aimed at making China more attractive for inclusion in simultaneous global drug development programs for drug registration in China.
Breaking Through Pharma Silos
Silos, which can create inefficiencies and confusion at pharma companies, also make it difficult for CROs and other service providers to sell their clinical trial services. While service providers have always found silos difficult to navigate when selling services to large pharmaceutical companies, in recent months, the task has become harder due to the economic downturn and widespread changes in drug sponsor outsourcing practices.
ICREL Survey Findings Reveal Need for EU CT Directive Changes
Multinational trials have become increasingly complex and timelines have lengthened since the European Union Clinical Trial Directive 2001/20/EC went into effect. This has resulted in stakeholders' need for more staff and ultimately higher costs to run drug development programs in Europe. While stakeholders have anecdotally drawn similar conclusions, a report by The Impact on Clinical Research of European Legislation (ICREL), is now able to provide hard data to back up these claims. The report demonstrates the significant impact of the directive on all stakeholders.
Eye On: Insomnia
Insomnia, or difficulty sleeping, may include trouble falling asleep or staying asleep, usually associated with feeling groggy on awakening, daytime sleepiness, low energy, poor concentration, irritability and difficulty functioning at school or work. This common problem affects more than one-third of adults at some point during their lifetimes, and 10% to 15% of adults have chronic insomnia.
To read the full articles for this issue or for more information on these and other breaking stories, please click here for subscription information.