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1. 发明申请

US20210280304A1 INTEGRATED CLINICAL TRIAL DESIGN AND DESIGN OPTIMIZATION 有权
公开(公告)号：US20210280304A1
公开(公告)日：2021-09-09
申请号：US17194434
申请日：2021-03-08
申请人： Gen LI
发明人： Gen LI
IPC分类号： G16H40/20 , G16H10/20 , G16H70/60 , G16H10/60 , G16H50/70 , G06F16/25
摘要： Clinical trial protocols frequently need to be amended during a clinical trial, but the amendments are costly and can delay new drug approval. It is challenging to avoid, reduce or minimize incidences of amendments. Currently, people have to manually identify flaws of protocol, which is slow and may incur errors due to subjective perspectives and lack of objective, sufficient, and structured data. The present invention discloses an integrated clinical trial design and design optimization platform that efficiently reduces/minimizes incidences of amendments. In one embodiment, the protocol design or optimization is based on data. In one embodiment, the result is more accurate, quantitative and less error-prone; the system can quickly identify flaws; the flaws can be detected at an earlier stage and the system can distinguish key and leading factors and variables, helping sponsors identify the most efficient amendment.

2. 发明申请

US20210134404A1 METHODS OF FORECASTING ENROLLMENT RATE IN CLINICAL TRIAL 有权
公开(公告)号：US20210134404A1
公开(公告)日：2021-05-06
申请号：US17148782
申请日：2021-01-14
申请人： Gen LI
发明人： Gen LI
IPC分类号： G16H10/20
摘要： In one embodiment, the present invention provides a method and system of designing a clinical trial enrollment plan, comprising the use of non-linear regression analysis to model the relationship between a pair of clinical trial parameter, e.g., the relationship between N and GSER (Gross Site Enrollment Rate) and the relationship between N and CTER (clinical trial enrollment rate). The values of the other parameter of the pair can be extrapolated from said regression analysis, wherein said extrapolated values of the parameters are outputted as a design or plan product which will be used in clinical trial for improving the performance

3. 发明申请

US20200350041A1 METHODS OF FORECASTING ENROLLMENT RATE IN CLINICAL TRIAL 审中-公开
公开(公告)号：US20200350041A1
公开(公告)日：2020-11-05
申请号：US16931692
申请日：2020-07-17
申请人： Gen LI
发明人： Gen LI
IPC分类号： G16H10/20 , G16H40/20
摘要： In one embodiment, the present invention provides a method of designing a clinical trial enrollment plan, comprising the use of non-linear regression analysis to model the relationship between the number of investigator sites and the site enrollment rates, or the relationship between the number of investigator sites and the trial enrollment rates. One or more parameters such as the number of investigator sites, site enrollment rates, and/or trial enrollment rates can then be extrapolated from said regression analysis, wherein said extrapolated parameters are used in the design of one or more clinical trial enrollment plans

4. 发明申请

US20190006025A1 METHODS OF FORECASTING ENROLLMENT RATE IN CLINICAL TRIAL 审中-公开
公开(公告)号：US20190006025A1
公开(公告)日：2019-01-03
申请号：US16124369
申请日：2018-09-07
申请人： Gen Li
发明人： Gen LI
IPC分类号： G16H10/20
摘要： In one embodiment, the present invention provides a method of designing a clinical trial enrollment plan, comprising the use of non-linear regression analysis to model the relationship between the number of investigator sites and the site enrollment rates, or the relationship between the number of investigator sites and the trial enrollment rates. One or more parameters such as the number of investigator sites, site enrollment rates, and/or trial enrollment rates can then be extrapolated from said regression analysis, wherein said extrapolated parameters are used in the design of one or more clinical trial enrollment plans

5. 发明申请

US20170270279A1 METHOD AND SYSTEM FOR IMPROVING SITE ACTIVATION THROUGH CRITICAL PATH MANAGEMENT AND IMPROVING PATIENT ENROLLMENT THROUGH FOCUSED SITE MANAGEMENT 审中-公开
公开(公告)号：US20170270279A1
公开(公告)日：2017-09-21
申请号：US15457061
申请日：2017-03-13
申请人： Gen Li
发明人： Gen Li
IPC分类号： G06F19/00
CPC分类号： G16H10/20
摘要： The present invention discloses methods for improving clinical trial planning and clinical trial operations deliverables. Specially, this invention introduces methods on shortening enrollment cycle time and/or improving more effective utilization of resources through critical path management in site activation and improvement of patient enrollment in focused site management.

6. 发明申请

US20220223237A1 METHOD AND SYSTEM FOR DEVELOPING CLINICAL TRIAL PROTOCOLS 有权
公开(公告)号：US20220223237A1
公开(公告)日：2022-07-14
申请号：US17705549
申请日：2022-03-28
申请人： Gen LI
发明人： Gen LI
IPC分类号： G16H10/20 , G16H70/60 , G16H15/00 , G16H50/20
摘要： The present invention discloses methods and systems for developing clinical trial protocols, in particular, the inclusion/exclusion criteria used to define targeted patient population. In some embodiments, the present invention provides methods and systems to develop and/or optimize the inclusion/exclusion criteria based on quantitative analysis. In some embodiments, the methods and systems of the present invention allow to achieve the objectives of a clinical trial.

7. 发明申请

US20210257061A1 METHOD AND SYSTEM FOR DEVELOPING CLINICAL TRIAL PROTOCOLS 有权
公开(公告)号：US20210257061A1
公开(公告)日：2021-08-19
申请号：US17265414
申请日：2019-08-08
申请人： Gen LI
发明人： Gen LI
IPC分类号： G16H10/20 , G16H15/00 , G16H50/20 , G16H70/60
摘要： The present invention discloses methods and systems for developing clinical trial protocols, in particular, the inclusion/exclusion criteria used to define targeted patient population. In some embodiments, the present invention provides methods and systems to develop and/or optimize the inclusion/exclusion criteria based on quantitative analysis. In some embodiments, the methods and systems of the present invention allow to achieve the objectives of a clinical trial.

8. 发明申请

US20190080785A1 METHODS OF FORECASTING ENROLLMENT RATE IN CLINICAL TRIAL 审中-公开
公开(公告)号：US20190080785A1
公开(公告)日：2019-03-14
申请号：US16190910
申请日：2018-11-14
申请人： Gen LI
发明人： Gen LI
IPC分类号： G16H10/20 , G06F19/00
摘要： In one embodiment, the present invention provides a method and system of designing a clinical trial enrollment plan, comprising the use of non-linear regression analysis to model the relationship between a pair of clinical trial parameter, e.g., the relationship between N and GSER (Gross Site Enrollment Rate) and the relationship between N and CTER (clinical trial enrollment rate). The values of the other parameter of the pair can be extrapolated from said regression analysis, wherein said extrapolated values of the parameters are outputted as a design or plan product which will be used in clinical trial for improving the performance

9. 发明授权

US09428508B2 2,4-diamino-6,7-dihydro-5H-pyrrolo[2,3]pyrimidine derivatives as FAK/Pyk2 inhibitors 有权
标题翻译： 2,4-二氨基-6,7-二氢-5H-吡咯并[2,3]嘧啶衍生物，为FAK / Pyk2抑制剂
公开(公告)号：US09428508B2
公开(公告)日：2016-08-30
申请号：US13978475
申请日：2012-01-07
申请人： Dengming Xiao , Liang Cheng , Xijie Liu , Yuandong Hu , Xinhe Xu , Zhihua Liu , Lipeng Zhang , Wei Wu , Shulong Wang , Yu Shen , Gen Li , Yin Wang , Sheng Zhao , Chonglong Li , Jia Tang , Honghao Yu
发明人： Dengming Xiao , Liang Cheng , Xijie Liu , Yuandong Hu , Xinhe Xu , Zhihua Liu , Lipeng Zhang , Wei Wu , Shulong Wang , Yu Shen , Gen Li , Yin Wang , Sheng Zhao , Chonglong Li , Jia Tang , Honghao Yu
IPC分类号： C07D487/04 , C07D413/12 , A61K31/519 , A61K31/5377 , A61K31/541 , A61K31/4523 , A61P35/00 , C07D401/12 , C07D493/12 , C07D417/12
CPC分类号： C07D487/04 , A61K31/4523 , A61K31/519 , A61K31/5377 , A61K31/541 , C07D401/12 , C07D413/12 , C07D417/12 , C07D493/12
摘要： The invention relates to a novel class of 2,4-diamino-6,7-dihydro-5H-pyrrolo[2,3]pyrimidine derivatives as a FAK and/or Pyk2 inhibitor, to a process for their preparation, and to a composition thereof, as well as to use of the compounds for the inhibiting FAK and/or Pyk2 and method for the treatment of a FAK and/or Pyk2 mediated disorder or disease.
摘要翻译：本发明涉及一种新型的作为FAK和/或Pyk2抑制剂的2,4-二氨基-6,7-二氢-5H-吡咯并[2,3]嘧啶衍生物，其制备方法和组合物以及该化合物用于抑制FAK和/或Pyk2的方法和用于治疗FAK和/或Pyk2介导的病症或疾病的方法。

10. 发明申请

US20160042155A1 METHODS OF FORECASTING ENROLLMENT RATE IN CLINICAL TRIAL 审中-公开
标题翻译：预测临床试验中入选率的方法
公开(公告)号：US20160042155A1
公开(公告)日：2016-02-11
申请号：US14818438
申请日：2015-08-05
申请人： Gen Li
发明人： Gen LI
IPC分类号： G06F19/00
CPC分类号： G16H10/20 , G06F19/00 , G06F19/325 , G16H40/20
摘要： In one embodiment, the present invention provides a method of designing a clinical trial enrollment plan, comprising the use of non-linear regression analysis to model the relationship between the number of investigator sites and the site enrollment rates, or the relationship between the number of investigator sites and the trial enrollment rates. One or more parameters such as the number of investigator sites, site enrollment rates, and/or trial enrollment rates can then be extrapolated from said regression analysis, wherein said extrapolated parameters are used in the design of one or more clinical trial enrollment plans
摘要翻译：在一个实施例中，本发明提供了一种设计临床试验注册计划的方法，其包括使用非线性回归分析来建模研究者站点数量与站点注册率之间的关系，或者调查员网站和试用注册率。然后可以从所述回归分析中推算一个或多个参数，例如研究者地点的数量，站点登记率和/或试验注册率，其中所述外推参数用于设计一个或多个临床试验注册计划

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