到2020年，纳什将成为全球肝移植的主要原因。IQVIA的NASH卓越中心提供了解决方案，以加快治疗选择的发展。
寻求新的机会来开发未满足医疗需求的药物的制药公司越来越吸引非酒精性脂肪性肝脏（NASH）的患者。NASH是非酒精性脂肪肝病（NAFLD）的严重形式，其中脂肪在肝脏中积累，引起炎症，纤维化，肝硬化和肝癌。这是美国和国外日益增长的医疗问题。
However, stratifying and referring the right patients for clinical trials is a challenge. IQVIA internal analysis shows the average rate of enrollment for NASH studies in the US and Europe is just 0.4 patients per site, per month, which translates to huge time and cost challenges.
Currently there are no treatment options beyond diet and exercise. While the exact cause of NASH isn’t clear, it is more common among people with type-2 diabetes and obesity. As the numbers of people with these conditions increase so too will the rate of patients suffering from NASH, creating heavy consequences on healthcare systems. It’s also driving multiple pharmaceutical manufacturers to pursue novel treatments for this unmet medical need. The therapeutic market for NASH is currently estimated to reach$35-40 billion by 2025，目前正在开发数十种药物，还有一些已经进入phase III studies.
不幸的是，纳什唯一确定的诊断工具是肝活检。其他支持NASH诊断的非侵入性生物标志物，例如血液测试或MRI扫描，不足以做出明确的诊断。由于缺乏意识和治疗选择，目前，医师不愿进行痛苦且昂贵的肝活检。根据IQVIA的说法，这一事实使这种不情愿更加复杂：根据IQVIA的数据，对可疑的NASH患者进行的一半以上的肝脏活检最终会产生负面结果。
Other important factors impacting clinical trial recruitment in this area include:
- NASH is generally an asymptomatic disease until late.
- 患者缺乏对疾病的认识。
- 许多关心NASH患者的医生不熟悉该疾病及其后果。
All of these challenges are converging to make NASH clinical trials uniquely difficult to deliver.
纳什具有挑战性问题的新解决方案
To change the paradigm in NASH a new approach is needed. Tapping advanced analytics and innovative diagnostics to identify undiagnosed patients. Educating providers and patient advocacy groups about risk factors and warning signs. Supporting trial sites in new, more proactive ways. Embracing real-world evidence to better assess risk, and create market access and reimbursement strategies that make sense for NASH and the patients it affects.
In response, IQVIA’s NASH Center of Excellence is leveraging the IQVIA CORE™ to develop innovative data analytics and delivery models for complex clinical trial patient recruitment. Unparalleled data assets allow us to accelerate the identification and treatment of undiagnosed patients, and predictive analytics and algorithms help identify risk factors among NASH patients and define the patient recruitment funnel. Our Integrated NASH Site Network (INN ) then links patients and referral practices to the investigative sites in a seamless fashion.
伊克维亚（Iqvia）在过去的几年中还花费了更多的时间研究更具创新性的，非侵入性的诊断选择，包括血液检查，成像和探针，这些探针使用声波非侵入性地测量肝脏的状况。通过与成像和血清生物标志物公司的合作，IQVIA可以预测纤维化，脂肪变性（例如脂肪）和炎症的存在。该领域的进步提供了希望，希望较少的入侵工具将很快被批准诊断纳什患者并确认试验参与。
Recruiting patients for NASH trials will always be challenging, but by constantly challenging the status quo, and by being creative in building the right network model, better education programs, data-driven recruiting strategies, and more innovative diagnostic tools, IQVIA is leading the way toward new solutions.
To learn more about NASH, read a recent 2-part series from IQVIA’s Senior Medical Director and Strategy Lead in the NASH Center of Excellence:
并深入研究IQVIA如何利用Core™开发创新的分析和技术驱动的解决方案来帮助客户导航NASH景观（无论是在批准之前还是之后）。