trial implementation

The Trials of Trial Implementation

In Clinical Development, Regulation & Government by Freya SmaleLeave a Comment

This guest blog post was provided by Premier Research. In part three of our four-part panel discussion at the World Orphan Drug Congress in Washington, DC: “Making Rare Disease Clinical Trials Feasible,” the panel focused on implementation challenges when running clinical trials for rare diseases. Once again, Frank Armstrong (Medical Advisor) kicked off the discussion by highlighting a statistic from a Premier Research survey of groups involved in clinical trials in rare diseases, finding that that 69% of respondents commented that identifying and setting up clinical sites is among the biggest issue in running trials. Our own Angi Robinson (Scientific Account Leader) hit on some of the challenges that are faced when setting up clinical sites. Often you may only have a handful of physicians who are experts on a particular rare disease which can hamper getting trials started. With certain rare diseases, you often have to follow the patients because you’re dealing with such a small pool of prospective patients. Following in that vein, Phil Vickers (Senior Vice President and Head of Research and Development, Shire HGT) talked about the costly challenges that come with having to set up many sites across the globe with often very few patients. John Orloff (Chief Medical Officer at Novartis) stressed how important it is to leverage technology to monitor patients remotely, and setting up community centers to better deliver these trials to patients who otherwise would be unable to access them. We’ll wrap up our coverage of this conversation with our next post. We’re pleased to be a sponsor of the 4th Annual World Orphan Drug Congress , November 14-15, 2013. We’re currently developing our panel discussion, and would love to hear from you about what you’d like to see us cover with our Geneva panel. Let us know in the comments below, or send us an email at info@premier-research.com.

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