As a complex, inherited disease, cystic fibrosis impacts the respiratory, gastrointestinal and reproductive systems. Many clinical trials are examining therapies that target this rare disease from different therapeutic angles, such as restoring function to a faulty protein, reducing inflammation, clearing mucus buildup, addressing gastrointestinal manifestations or fighting cystic fibrosis-related infections.
Covance目前正在支持几种完整的开发计划和来自IV的阶段纤维化研究。Christine Tiesler，高级导演，炎症，传染病和一般医学（IIGM）和Karina Putineanu，IIGM，最近分享了他们对赞助商，CRO和网站之间的联营努力如何帮助推进囊性纤维化临床试验的见解世界规模。
与知情人士合作
With 75,000 known cases around the world and 30,000 of those in the U.S., cystic fibrosis is considered a rare disease even though it is the most common genetic disease in Caucasians. Most people with cystic fibrosis were diagnosed by the age of two and screening programs often identified the disease shortly after birth.
Despite being a relatively small patient population, people with cystic fibrosis are very informed about their options for receiving standard treatments and joining clinical trials, thanks to widespread availability of cystic fibrosis-related information from a strong network of cystic fibrosis foundations in the U.S., Europe and Australia.
接受有价值的投入
While cystic fibrosis foundations provide guidance to patients on their available treatment choices, they can support pharmaceutical drug development and CROs by providing input on clinical trial protocols.
囊性纤维化基础也建议关于严格的研究行为标准。在Covance，我们的临床研究伙伴（CRAs）和关键项目管理功能根据囊性纤维化基础提供的指导培训。这项培训有助于确保CRAS了解挑战，可以提供足够的监控，最终满足运营这些专业临床研究所需的许多独特要求。
患有囊性纤维化的建立的药物开发公司通常与网站和关键意见领导者（KOL）具有密切合作和长期的关系。对于空间来说是新的赞助商必须建立这个网络或依靠他们的CRO合作伙伴来促进这些联系。
囊性纤维化基础还通过既定的沟通渠道对CRO在现场的表现提供了重要反馈。这种持续的知识共享最大限度地减少了关键问题，有助于保持网站，CRO和赞助商之间的密切合作，并有助于确保CRO在快速变化的景观中保持步伐。
缓解网站的负担
囊性纤维化是如何影响的复杂性s many systems in the body and patient care cannot be handled with a single provider, an interdisciplinary team is required at each clinical site, which often can include a dietician, respiratory specialist and psychologist.
支持囊性纤维化临床试验的CROS必须努力使整个过程非常简单地为网站协调交付的许多方面。这种服务级别在一个非常竞争力的领域尤为重要，许多公司正在寻求经验丰富的CF站点。
Beyond developing a strong working relationship with sites, Covance leverages our extensive site relationships within this specialized cystic fibrosis network, we and can open up potential opportunities to secure these locations for the studies we conduct on behalf of our clients.
应用经过验证的经验
在囊性纤维化的临床试验重新进行收益quires comprehensive solutions, from processing lab results and spirometry readings to nurturing longstanding relationships between sponsors, CROs, labs and foundations. These alliances can make a difference in running efficient studies and addressing the urgent need to find viable treatments to improve the lives of people with cystic fibrosis.
To make the most of your cystic fibrosis drug development, take advantage of our solutions and expertise at Covance. From central laboratory testing with sweat chloride and spirometry to our full range of CRO service such as genotyping and comprehensive monitoring solutions through the Xcellerate® Informatics Suite,我们在这里帮助推进您的学业。
Reference:囊性纤维化基础
