Ethics/Regulatory

NIH forms team to chart course for Precision Medicine Initiative research network

Wednesday, April 1, 2015

A newly created team of experts in precision medicine and large clinical research studies will seek public input from the large and diverse stakeholder community interested in the development of the President’s Precision Medicine Initiative and articulate the vision for building the national participant group for the Initiative. They will help define what can be learned from a study of this scale and scope, what issues will need to be addressed and considered as part of the study design and what success would look like five and 10 years out.

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Regulatory compliance an increasing burden on sites

Wednesday, April 1, 2015

As the biopharmaceutical industry strives to reduce its R&D costs and shorten timelines, it must face the fact that to­day’s successful drug development plans often require more clinical studies than they did a dozen years ago.

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Report: Transparency, cooperation help reduce high prices for new medicines

Friday, March 27, 2015

As the number of new medicines introduced in Europe rises, governments are finding it increasingly difficult to afford them, according to a comprehensive study released today by the WHO Regional Office for Europe. The study illustrates the challenges for national health systems, with specific examples, and shows that few countries in the WHO European Region have mechanisms in place to evaluate the cost-effectiveness of new drugs; this hampers the value-assessment and decision-making processes.

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BRANY earns five-year AAHRPP accreditation

Wednesday, March 18, 2015

BRANY has successfully continued its full accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). The five-year accreditation reflects BRANY’s continuing commitment to protecting the rights and welfare of research participants. AAHRPP’s accreditation process helps organizations consistently meet ethical principles and standards for protecting research participants.

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