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Op-Ed: Major Reforms in the Financing and Oversight of Clinical Research Neededt

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By KATHLEEN BOOZANG

Seton Hall University School of Law’s Center for Health & Pharmaceutical Law & Policy has called for major substantive reforms in the financing and oversight of clinical research. In a White Paper entitled “ Conflicts of Interest in Clinical Trial Recruitment & Enrollment: A Call for Increased Oversight,” the Center proposes legal and policy changes to address conflicts of interest in the relationships between industry and doctors that can create unwarranted risks to trial participants and to the scientific integrity of research.

Over 60% of testing of experimental drugs and medical devices now occurs in physicians’ private offices; unlike years past, industry funds a much higher percent of clinical trials than government, frequently paying researchers significantly more than government does. For some physician practices, conducting clinical trials represents a significant portion of their income.Continue reading…

Science Is Leading Us to More Answers, but It’s Also Misleading Us

Be careful what you wish for. That is the unexpected lesson of the past decade of biomedical research, which has been characterized by an overwhelming abundance of interesting things to study and powerful ways to study them. A pioneer of this era, MIT geneticist Eric Lander, speaks eloquently of the “global view of biology,” meaning that scientists now have extraordinary tools to study not only individual genes, but also multiple genes at the same time. Rather than immediately investing all their resources in a few favorite genes (the traditional approach), modern researchers first can survey thousands of initial candidates, then identify and ultimately direct their attention to the most important players and pivotal networks.But we are increasingly discovering that this global perspective comes at an unexpectedly steep price: We’re making a lot more mistakes. Or, at least, we seem to be having a lot of trouble picking out the rare, meaningful signal from the deafening noise in the background.

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