Life Science Compliance Update

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August 29, 2013

NIH To Support Big Data to Knowledge Centers of Excellence

NIH announced that it will fund up to $24 million per year for four years ($96 million total) to establish six to eight investigator-initiated Big Data to Knowledge Centers of Excellence. The centers will improve the ability of the research community to use increasingly large and complex datasets through the development and distribution of innovative approaches, methods, software, and tools for data sharing, integration, analysis and management. The centers will also provide training for students and researchers to use and develop data science methods.

Biomedical research is increasingly data-intensive, with researchers routinely generating and using large, diverse datasets. Yet the ability to manage, integrate and analyze such data, and to locate and use data generated by others, is often limited due to a lack of tools, accessibility, and training. In response, NIH launched the Big Data to Knowledge (BD2K) initiative in December.

This initiative supports research, implementation, and training in data science that will enable biomedical scientists to capitalize on the transformative opportunities that large datasets provide. The investigator-initiated BD2K Center of Excellence funding opportunity is the first of several BD2K funding opportunities to be announced in coming months.

"BD2K aims to enable a quantum leap in the ability of the biomedical research enterprise to maximize the value of the growing volume and complexity of biomedical data," says Eric Green, M.D., Ph.D., NIH acting associate director for data science and director of the National Human Genome Research Institute. "The Centers of Excellence will provide a key component of the overall initiative."

By encouraging the formation of interdisciplinary teams in a collaborative environment the BD2K Centers of Excellence also seek to increase the involvement of investigators outside of traditional biomedical areas who are experienced with data science.

"This funding opportunity represents a concerted effort to leverage the power of NIH in developing cutting-edge systems to address data science challenges," said NIH Director Francis S. Collins, M.D., Ph.D. "The goal is to help researchers translate data into knowledge that will advance discoveries and improve health, while reducing costs and redundancy."

Applicants responding to the BD2K Center of Excellence funding opportunity announcement should identify a research topic and propose research in data science. They should develop approaches, methods, software, and tools for data integration, analysis, database development and management, and visualization and modeling to address important research questions. The products from this research and development will be shared and distributed broadly to the research community. The centers are expected to interact as a consortium that cooperatively builds on individual research efforts.

An information webinar for prospective applicants will be held on Thursday, Sept. 12, 2013, from 3 p.m. to 5 p.m. EDT. More details about this event and the overall BD2K initiative can be found at http://bd2k.nih.gov. Applications will be due on Nov. 20, 2013.

In other news, NIH announced in July that due to the "unstable regulatory environment" in India, it has cancelled almost 40 ongoing clinical trials taking place in the country.

The unstable regulatory environment is one reason why "sponsors are being driven away to places like Malaysia and Canada," reported BioSpectrum.

"The move comes as the health ministry, after the Supreme Court's intervention, tightened regulatory norms for trials. The health ministry amended the Drugs and Cosmetics Act with new laws for regulation and ethical supervision of trials; compensation of trial subjects; and mandatory accreditation of all stakeholders—institutional review boards, research institutions, sponsors and contract research organizations."

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