CenterWatch Monthly August 2009
Working at the Global Level in China
China’s increasing participation in global drug development programs requires personnel who are experienced working at the global level. Finding such talent is a universal problem, and the problem is exacerbated in emerging markets with shorter clinical research histories.
Stimulus Law Expands HIPAA Requirements
The economic stimulus law passed in February includes changes in HIPAA that become effective in 2010 and represent an expansion of HIPAA requirements for research institutions.
Both the Common Rule and the HIPAA Privacy Rule require an assurance that the privacy of an individual trial participant, particularly regarding personal health information, is never breached. However, a number of studies now show that HIPAA regulations actually impede research and do not provide added privacy protection. A new report from the Institute of Medicine recommends changes in HIPAA as it applies to research.
Europe Seeks Boost in Elderly Trial Participants
About one-fifth of Europe’s population is already older than 65 years of age, or classified as “elderly,” and geriatricians and other stakeholders are now asking that more relevant data be available to doctors who prescribe drugs to them. The elderly’s underrepresentation in clinical trials is the main contributor to the lack of relevant data.
Eye On: Lung Cancer
Primary lung cancer arises from tissues within the lung, typically in the cells lining the airways. Small-cell and non-small-cell lung cancer (NSCLC), which are differentiated by their microscopic appearance, are the two leading types of lung cancer.
Despite the availability of numerous treatments, including surgery, radiation and chemotherapy, lung cancer is still the leading cause of cancer deaths worldwide. Lung cancer continues to be a major source of mortality in the United States, with estimated new cases in 2009 being 219,440 and estimated deaths being 159,390, according to the National Cancer Institute.
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