tion research. Also, the new National Institute of Minority Health and Health Disparities has created new programs to address disparities. “I am optimistic that they are really going to be able to make some real catalytic changes,” Hudson said.

Dunsire observed that the response of population groups to drugs can differ not only within the United States but around the world. Phase I trials cannot be done just in the United States and Europe, with the drug then being taken around the world, because the drug can act differently with different populations. Health disparities do not necessarily arise from genetic factors, she said, but genetic factors need to be taken into account. Dzau agreed, adding that the social, cultural, and environmental influences on health point to the need to involve social scientists in collaborations. For instance, one way of involving social scientists would be to have anthropologists help develop culturally specific ways of encouraging participation and gathering information in research.

PATIENT AND PHYSICIAN EDUCATION

Particular attention needs to be directed toward patients and physicians in the drug development ecosystem, several presenters said. According to Ginsburg, only 5 percent of oncology patients are currently in clinical trials in the United States. Patients need to be educated about why their tissues are needed, how they will be used, and how that use could change treatments, Dunsire said. She noted that we are at a critical junction for patients regarding their understanding of the importance of participation and the benefits for doing so. Hudson said that a much better job needs to be done of communicating to prospective participants what the potential value and risk is to them for participating in research. “Ideally, we would all be, as patients, also participating in research.”

A national dialogue about research participation could enhance the ability “to get people to participate and sign that form that says, ’Yes, I would like my tissue and my clinical information to be a part of future research studies,’” Hudson said.

AN EMPHASIS ON THE SCIENCE

In his concluding remarks, Ginsburg pointed out that the workshop began with an industry in crisis. It ended with a discussion of how collaborative efforts could lead the way toward a new era of drug discovery and development that could provide immense benefits to human health.

The essential resource that will enable this transformation is scientific knowledge, Ginsburg said. “We need to understand the biological underpinnings of the diseases and the pathways that we’re trying to affect.”



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