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wanghaisheng / OHDSI-Research

对OHDSI的研究
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素材 EMIF #33

Open wanghaisheng opened 6 years ago

wanghaisheng commented 6 years ago
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  1. I期临床试验：初步的临床药理学及人体安全性评价试验。观察人体对于新药的耐受程度和药代动力学，为制定给药方案提供依据。该期需要病例数较少，一般为20-80例。

  2. II期临床试验：治疗作用初步评价阶段。其目的是初步评价药物对目标适应症患者的治疗作用和安全性，也包括为III期临床试验研究设计和给药剂量方案的确定提供依据。此阶段的研究设计可以根据具体的研究目的，采用多种形式，包括随机盲法对照临床试验。该期的病例数比一期多，一般为100-300例。

  3. III期临床试验：治疗作用确证阶段。其目的是进一步验证药物对目标适应症患者的治疗作用和安全性，评价利益与风险关系，最终为药物注册申请获得批准提供充分的依据。试验一般应为具有足够样本量的随机盲法对照试验。该期的病例数更大，一般为1000-3000。

  4. IV期临床试验：新药上市后由申请人自主进行的应用研究阶段。其目的是考察在广泛使用条件下的药物的疗效和不良反应;评价在普通或者特殊人群中使用的利益与风险关系;改进给药剂量等。

wanghaisheng commented 6 years ago

The most comprehensive knowledge base on Alzheimer's and Parkison's disease worldwide

http://aetionomy.scai.fhg.de/

wanghaisheng commented 6 years ago
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RWD 在药企中的应用场景

Discovery

• Biomarker discovery • Predictive modelling • Disease insight generation (opportunity identification)

Development

• Trial design and feasibility analysis • EHR-facilitated recruitment • Prospective cohort selection

Deployment

• Analysis treatment pathways • Collection clinical & economic evidence • Ongoing efficiency & safety monitoring

wanghaisheng commented 6 years ago

RWD 生态链

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Benefits • Targeted clinical trial program • Accuracy of trial planning and data collected • Speed of recruitment and data collection • Cost savings

Issues Governance • Access model & permissions Costs • Data fee Interoperability of clinical systems • Multiple systems • How to put data together - common data models Linking while preserving confidentiality • Trusted third parties • Inherent identifiability Quality of data Analytics • Costs • Expertise Patient consent models

2. Alison IMS EMIF March 2016.pdf