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On the Day World Recognizes 350m Rare Disease Sufferers, Quintiles Publishes Insights in Tackling the Challenges

[By NBC-1TV H. J Yook]March 3, 2014 -- Marking today’s commemoration of ‘World Rare Disease Day’, Quintiles (www.quintiles.com)points to the 350 million people around the globe suffering from rare diseases - gathered together they would be the world’s third most populous nation - by highlighting its own contribution to tackling this challenge with a new collection (http://goo.gl/OzqEE5) of papers, podcasts and videos covering the latest developments and insights.

A rare disease is one that affects fewer than 200,000 Americans at any given time, according to the U.S. Food and Drug Administration.[1] In Europe, a disease or disorder is defined as rare when it affects less than 1 in 2000.[2] Milena Kanova, M.D., senior director, project management at Quintiles, explains. “Because rare diseases occur in relatively small numbers of people, patient recruitment can pose one of the greatest challenges in these type of clinical trials.”

Quintiles has been involved in more than 80 rare disease clinical trials, involving almost 11,000 patients in 52 countries. Based on that experience, the released today presents insights and perspectives on the design of clinical trials for rare diseases, drug commercialization and patient outcomes.

Supporting the publication of these insights, in a new podcast (http://goo.gl/OzqEE5), Dr. Kanova explains the approach used for rare disease clinical trials and how the model can be adapted to address any rare disease. This approach involves designing trials to include data-driven monitoring, triggered initiation of sites and recruitment planning tailored for the rare disease space.

In addition to clinical development, Quintiles’ global footprint helps improve patient-reported outcomes. By partnering with sponsors and research organizations, Quintiles has been able to develop numerous registries for rare diseases, including hemophilia, cystic fibrosis and rare cancer indications, among others.

“The depth of our market penetration allows us to conduct relatively large long-term studies, including some that aim to capture information on every patient treated with a particular product,” said Kathryn Starzyk, Sc.M., director of epidemiology, Real-World Late Phase Research at Quintiles.



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