1、?HLT?HLT is committed to enhancing global pharmaceutical research and development（征求意见稿）2019?11?(HLT)Prepared by Happy Life Technology(HLT)，November 1st,2019Acknowledgement:Prof.Chen Yao(Peking University)Dr.Xiaoning He(Tianjin University)Ms.Jing Yang(HLT)Mr.Yiming Hao(HLT)Dr.Tengbin Xiong(HLT)Mr.Ya

2、zhou Gao(HLT)Mr.Sijia Lou(HLT)?1?1.?HLT?1?1.1?HLT?1?1.2?2?2.?3?2.1?3?2.2?RWE?3?2.3?RWE?4?3.?HLT?6?3.1?HLT?6?3.2?HTL?6?4.?HLT?7?4.1?RWE?7?4.2?HLT?RWE?8?5.?RWE?9?5.1?RWE?9?5.2?RWD?9?5.3?RWE?10?5.4?RWE?10?6.?11?6.1?对?11?6.2?对?11?6.3?12?6.4?13?7.?RWE?14?7.1?14?7.2?FDA?RWE?15?7.3?CFDA?15?1.?16?2.?17卷首语?预

3、?预?缺?意?RWE?忽?剂?缺?分?分?热?德?HLT?点?挖?危?预?分?预?预?危?分?受?分?纳?HLT?分?预?缺?糖?HLT全?预?德?忽?缺?德?RWE?RWE?RWE?德RWE忽德?性?续?预?Director,RWE Solutions and HEOR Happy Life Technology November?1卷语?.?HLT?.1.1?HLT?预?忽?意?忽?HLT?分?HLT?分?HLT?分?意?HLT忽?HLT-iCD?纳?德?德?纳?危?CRO纳?IND?纳?点?分?CRO?SMO?纳?HLT?1-3?忽?HLT?预?10?危?FIH?忽2018?预?HLT?

4、纳?忽?HLT-iCD?纳?危?纳?39?忽?100?98?2?HLT?德?缺?瞄?纳?德忽?1?1?1?缺?性?1?HLT?11.数据赋能产业，HLT助力真实世界证据HLT?德?HLT?缺?德?德?忽?续60%?续?1.2?21?预?意?分?分?IT?缺?分?预?忽?OS?分?剂?忽?纳?凭?HLT?分?凭?分?德?忽?危?HLT?德?HLT?分?2?2.真实世界证据的?新形势、新变革、新面貌”2.1?忽?70?RCT?20?RCT?RCT?忽?忽?续?RCT?预忽?RWE?RCT?RWE?预?忽?忽?预?忽?RWE?缺?德?RWE?RWE分?2.2?RWE?RWE?危?忽?RWE?尖凭?尖

5、?RWE?RWE?HTA?/?危?32.真实世界证据的?新形势、新变革、新面貌?缺?RWE忽?缺?忽?德?德德?NICE?RWE?忽?2015?9?2016?22?2017?37?CADTH?德德?HAS?10%?25%?RWE?RCT?RWE?熟德?2017?G-BA?RWE?RWE?缺?HTA?2017?NICE?RWE?12%?RWE?23%?忽?德?2016?2017?HAS?RWE?11%?RWE?2 2.3 RWE?RWE?全?缺?RWE?忽?分?续?分?RWE?RCT?RWE?忽?分?挖?忽?凭?RWE?RWE?缺?RWE?RCT?RWE?缺瞄?4忽?缺?RWD?危?忽?RWE忽

6、?缺?预?德?德忽?预?德?缺?:2017 RWE benchmark survey by Deloitte?53.HLT致力提升全球医药研发能力3.1?HLT?HLT?1?德?缺忽?德?+AI?挖?危?德?2?德?续?3?预?挖?德?HLT?AI?续?分?德?分?德?3.2 HTL提供数据技术驱动的可行性方案 HLT?德?危?RWE?纳?德?德?德RWE?AI?忽?分?预?分?6?.HLT?4.HLT?4.1中国RWE质量水平亟待提升，高质量数据是发展的核心要素?5?29糖?德?预?续?预?德?预?缺?忽?缺?缺?危?预?RWD?缺?忽?预?RWD?RWE?剂?糖?潜?剂挖?凭?忽?挖?德?