Outsourcing in Drug Development: The Contract Research (Clinical Trial) Market22 Dec 2011 • by Natalie Aster
The Biotechnology Industry Organization (BIO) and a coalition of 21 patient groups wrote U.S. Health and Human Services Secretary Mike Leavitt to support the FDA’s Critical Path Initiative, which seeks to streamline the drug development process. Critical Path will help develop “the tools necessary to usher in the new era of personalized medicine,” said BIO President and Chief Executive Officer Jim Greenwood in his letter. "For people with devastating diseases and disabilities, road blocks to getting new products developed and approved can be matter of life or death." The groups urged Leavitt to make sure Critical Path programs receive priority and the resources necessary to succeed.
According to the report “Outsourcing in Drug Development: The Contract Research (Clinical Trial ) Market” by Kalorama Information drug development has become increasingly global as sponsors seek to accelerate patient recruitment by gaining access large treatment-naive patient populations, broaden access to trained investigators, and reduce clinical trial costs. Today clinical research is being conducted in Eastern Europe, Asia and Latin America, as well as other geographic regions. However, the United States remains the world's largest clinical research market.
Outsourcing in Drug Development: The Contract Research (Clinical Trial ) Market
Published: January 2012
Price: US$ 3,995.00
There are a number of reasons why the lion’s share of clinical research is being diverted away from AMCs and to private sector companies. The major reason is that clinical trial funding is made to a university in the form of a grant. Another major reason clinical research is being diverted away from AMCs relates to time delays in clinical trial starts. Despite the prestige associated with university teaching hospitals, they have been perceived as slow and inefficient in carrying out clinical trials, which is attributed to the unwieldy nature of academic bureaucracy. AMCs require that industry-investigator agreements be approved by an office of sponsored research.
More information can be found in the report “Outsourcing in Drug Development: The Contract Research (Clinical Trial ) Market” by Kalorama Information.
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