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Compliance In Focus
Posted by Michael Marotta on Thu, Jun 5, 2014

38 Million Reasons to Improve Clinical Trials

38 Million Reasons to Improve Clinical TrialsOn Friday, May 23, 2014 the Federal Register announced a notice that in an effort to increase the quality and efficiency of clinical trials, the Food and Drug Administration (FDA) was planning to grant a one-year, $7,500,000 grant to Duke University’s Translational Medicine Institute (DTMI) (renewable up to a total of five years, $37,500,000). This grant would primarily go to fund the public-private partnership Clinical Trials Transformation Initiative (CTTI).  CTTI  was originally created as a partnership between the FDA and Duke University in 2008, but now includes more than 60 organizations with representatives from government agencies, industry, patient advocacy groups, professional societies, investigator groups, academic institutions, and other interested parties.

Since the beginning, CTTI has undergone projects relating to various aspects of clinical trials and with direct relevance to the mission of the FDA.  These projects have ranged from accelerating antibacterial drug development and long-term opioid data to clinical trial monitoring, use of electronic data, and SAE reporting. One of the most recent publications from this initiative was a 2013 report relating to Expedited Safety Reports prior to the FDA’s final IND safety reporting rule. Each of the projects undertaken operates under CTTI’s three-pronged strategic approach:

  • To shape how clinical trials will be carried out in the future
  • To improve how clinical trials are currently conducted
  • To support discussions and decisions about how the portfolio of clinical trials are being done relative to unmet public health needs

With this new award, the Federal Register notice did not provide a specific list of projects the federal money would go towards funding, but rather provided a series of generalized examples of activities.  CTTI offers the ability to provide solutions to common problems that an individual company or entity would “ordinarily find prohibitively expensive.” This opportunity allows for both bringing to the table many different entities related to clinical trials, as well as rapidly gathering and generating data.  However with such a large umbrella required to encompass the various facets of clinical trials, and with an increase in trials occurring outside of the United States, it will be very interesting to see which areas are focused on first.

Going forward which area would you like to see examined?  Or which area do you think
would benefit from an approach towards increasing efficiency?

Photo Credit: paukrus

2013 Top FDA Warning Letters

Topics: Improve Clinical Trials, Federal Register, FDA

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