What are the different between epidemiology and pharmacoepidemiology：
流行病学和药物流行病学有什么区别：
Pharmacoepidemiology then can also be defined as the application of epidemiological methods to pharmacological issues. Epidemiology can be defined as the study of the distribution and determinants of diseases in populations
因此，药物流行病学也可以定义为流行病学方法对药理学问题的应用。流行病学可以定义为研究人群中疾病的分布和决定因素
pharmacoepidemiology：
药物流行病学：
Pharmacoepidemiology is applied science, using the principles and methods of epidemiology to study the utilization and effects of drugs.”
药物流行病学是应用科学，利用流行病学的原理和方法来研究药物的使用和效果。
Aims:
目标：
To elucidate the occurrence patterns of, and factors influencing drug effects in target population (drug effects actually include the beneficial effects and adverse effects of drugs)
阐明目标人群中药物作用的发生模式和影响因素（药物作用实际上包括药物的有益作用和不良作用）
To study the current state of drug abuse prevalence, characteristics, distribution and drug abuse prevention strategies.
研究药物滥用流行率、特征、分布和药物滥用预防策略的现状。
The ultimate goal: to improve safe and appropriate drug use and then ensure the safety of the general population
最终目标：改善安全和适当的药物使用，然后确保普通人群的安全
Epidemiology：
流行病学：
Epidemiology is the study of how often diseases occur in different groups of people and why. Epidemiological information is used to plan and evaluate strategies to prevent illness and as a guide to the management of patients in whom disease has already developed.
流行病学是研究疾病在不同人群中发生的频率以及原因的学科。流行病学信息用于规划和评估预防疾病的策略，并作为已经发生疾病的患者的管理指南。
The science of epidemiology includes etiology (the study of the causes of disease) and investigation of disease transmission (mechanisms by which a disease is spread).
流行病学包括病因学（研究疾病原因）和疾病传播调查（疾病传播的机制）。
Characters：
字符：
All findings must relate to a defined population
所有发现都必须与定义的总体有关
Oriented to groups rather than individuals
面向群体而非个人
Conclusions are based on comparisons
结论基于比较
adv and disadv of RWD compared to the data from RCTs
RWD 与 RCT 数据相比的 adv 和 disadv
RCTS
随机对照试验
Adv：The RCT has the ability to maximise the avoidance of various biases that can occur in the design and conduct of clinical trials, balance confounding factors, improve the validity of statistical tests, and many other advantages. It is recognised as the gold standard for evaluating interventions.
Adv： RCT 能够最大限度地避免临床试验设计和实施中可能出现的各种偏倚，平衡混杂因素，提高统计检验的有效性，以及许多其他优势。它被公认为评估干预措施的黄金标准。
Limited：
有限：
many RCTs have limited generalizability [1,6], and the conclusions of tightly controlled RCTs may apply only to the selected patient population
许多RCT的普遍性有限[1,6]，严格控制的RCT的结论可能仅适用于选定的患者群体
For example, the conditions under which patients receive the study drug are tightly controlled, and the narrow patient populations included in RCTs are often not representative of the general population in real-world clinical practice; such ‘real-world’ patients may have poorer performance status and compliance, and may include higher proportions of elderly patients
例如，患者接受研究药物的条件受到严格控制，RCT 中包含的狭窄患者群体通常不能代表真实世界临床实践中的一般人群;此类“真实世界”患者的体能状态和依从性可能较差，并且可能包括更高比例的老年患者
the treatment and follow-up periods are often short, potentially underestimating both long-term benefits and delayed hazards associated with treatment
治疗和随访期通常很短，可能低估了与治疗相关的长期益处和延迟危害
RCTs can be slow and costly to conduct and analyze
RCT 的进行和分析可能很慢，而且成本高昂
Improper use of placebo can lead to problems in medical ethics;
不当使用安慰剂会导致医学伦理问题;
RWD
后驱
Benefit：
效益：
reflect clinical experience across a broader and more diverse distribution of patients. It can provide insight into real-world treatment patterns, including dosing, compliance, adherence, off-label use and the balance between efficacy and safety in patient groups not included in RCTs
反映更广泛、更多样化的患者分布的临床经验。它可以提供对真实世界治疗模式的见解，包括剂量、依从性、依从性、超说明书使用以及 RCT 中未包括的患者群体的疗效和安全性之间的平衡
They often include larger sample sizes and longer follow-up periods than RCTs, which can allow assessment of rare/long-term outcomes and provide additional safety information after drug approval.
与 RCT 相比，它们通常包括更大的样本量和更长的随访期，这可以评估罕见/长期结局，并在药物批准后提供额外的安全性信息。
Data collection in patient registries can also aid post-marketing pharmacovigilance by providing an active surveillance system for the detection of any new safety signals
患者登记处的数据收集还可以通过提供主动监测系统来检测任何新的安全信号，从而帮助上市后药物警戒
as retrospective real-world studies use existing data sources, they can be more economical and time efficient than RCTs
由于回顾性真实世界研究使用现有数据源，因此它们可能比 RCT 更经济、更省时
Limited：
有限：
Concern about data quality
对数据质量的担忧
Research suggests that these concerns primarily originate from low-quality patients’ registries.
研究表明，这些担忧主要源于低质量的患者登记。
as retrospective real-world studies use existing data sources, they can be more economical and time efficient than RCTs
由于回顾性真实世界研究使用现有数据源，因此它们可能比 RCT 更经济、更省时
Standards
标准
Data standardization is important on a fundamental level that extends from the data collection, processing, quality, terminology, design principles, the conduct of data collection, or RWE reporting [3, 15-17]. Currently, there is a large gap in data standardization between all institutions which reduces the quality of RWD compared to the data originating from RCTs.
数据标准化在基本层面上很重要，从数据收集、处理、质量、术语、设计原则、数据收集行为或 RWE 报告 [3， 15-17]。目前，所有机构之间的数据标准化存在很大差距，与源自 RCT 的数据相比，RWD 的质量较低。
Coordination
协调
There is a lack of coordination between different organizations on a national and international level regarding RWD translation into evidence
在国家和国际层面上，不同组织之间在将 RWD 转化为证据方面缺乏协调
Governance
统辖
Legal frameworks and governance arrangements for RWD access are vital to allow different groups to access the required data in time to optimize healthcare for patients. Yet, RWD is generated by different sources such as academic institutions, hospitals, and private individuals;
RWD 访问的法律框架和治理安排对于允许不同群体及时访问所需数据以优化患者的医疗保健至关重要。然而，RWD 是由不同的来源产生的，例如学术机构、医院和个人;
most databases are often only accessible to researchers from academia upon request, while not being offered to other types of groups.
大多数数据库通常仅应要求提供给学术界的研究人员，而不提供给其他类型的团体。
Compliance
合规
Data privacy legislation will continue to be a major challenge that stakeholders must take into consideration when collecting data from any source.
数据隐私立法仍将是利益相关者在从任何来源收集数据时必须考虑的重大挑战。
Cost
成本
Pfizer,, mentioned that the costs of RWD analysis could be quite high, for example, in prospective noninterventional studies
辉瑞公司提到，RWD 分析的成本可能相当高，例如，在前瞻性非干预研究中
Cybersecurity 网络安全
网络安全
Cybersecurity is an important measure that must be considered when collecting a vast amount of sensitive data. In the case of RWD, these measures relate to unauthorized access or alteration, data theft, and data encryption.
网络安全是收集大量敏感数据时必须考虑的重要措施。对于 RWD，这些措施涉及未经授权的访问或更改、数据盗窃和数据加密。
data abuse can be triggered both by external factors, such as criminal cyberattacks and by internal factors, such as internal employees.
数据滥用既可能由外部因素（如刑事网络攻击）触发，也可能由内部因素（如内部员工）触发。
Bias
偏见
Expertise to analysis data
分析数据的专业知识
To rely on evidence from RWD, one must first be able to understand the data and have the skills to analyze it and generate valuable information that can be used in a decision-making process.
要依赖 RWD 的证据，首先必须能够理解数据并具备分析数据并生成可用于决策过程的宝贵信息的技能。
Major areas of knowledge
主要知识领域
The critical steps in the path from “bench to bedside” (as many as applicable, 5%) and the challenges of drug research and development (at least 3, 5%).
从“实验室到临床”的关键步骤（尽可能多，5%）和药物研发的挑战（至少 3,5%）。
Critical steps：
关键步骤：
Stage 1: Target identification and validation
第 1 阶段：靶标识别和验证
▪ Identify and validate the target of interests
▪ 识别并验证感兴趣的目标
▪ This involves findings a target molecule or biological pathway that is believed to be linked to a particular disease or condition.
▪ 这涉及发现被认为与特定疾病或病症相关的靶分子或生物途径。
▪ This can be done by analyzing existing data, generating new data, or performing laboratory experiments to confirm the target’s involvement in the disease.
▪ 这可以通过分析现有数据、生成新数据或进行实验室实验以确认靶标与疾病有关来实现。
Stage 2: Lead identification and optimization
第 2 阶段：潜在客户识别和优化
▪ Potential lead compounds are identified and optimized
▪ 识别和优化潜在的先导化合物
▪ Lead compounds are molecules that may be effective at treating a particular disease or condition.
▪ 铅化合物是可能有效治疗特定疾病或病症的分子。
▪ Compounds can be identified from existing databases, or synthesized from scratch in the laboratory.
▪ 化合物可以从现有数据库中鉴定，也可以在实验室中从头开始合成。
▪ Once identified, the lead compounds are optimized in a process known as lead optimization – a process of altering the structure of the lead compound to enhance its effectiveness and reduce any potential side effects.
▪ 一旦确定，先导化合物就会在称为先导化合物优化的过程中进行选择，该过程会改变先导化合物的结构以提高其有效性并减少任何潜在的副作用。
Stage 3: Formulation and preclinical testing
第 3 阶段：配方和临床前测试
▪ Once a promising lead compound has been identified and optimized, it will then be formulated into a drug product
▪ 一旦确定和优化了有前途的先导化合物，它就会被配制成药品
▪ This involves creating a formulation that can be administered to patients and is stable in the body.
▪ 这涉及创造一种可以给患者服用并在体内稳定的配方。
▪ Preclinical testing is also conducted at this stage to ensure the drug is safe and effective and this involves testing the drug in animal models and performing toxicology studies.
▪ 在此阶段还进行临床前测试，以确保药物安全有效，这包括在动物模型中测试药物和进行毒理学研究。
challenges of drug research and development ：
药物研发的挑战：
The components of a pharmaceutical system (as many as applicable, 5%) and how do they work together to yield desired health outcomes (give 3 examples, 5%).——举例介绍【相互配合】
制药系统的组成部分（尽可能多，5%）以及它们如何协同工作以产生预期的健康结果（举 3 个例子，5%）。——举例介绍【相互配合】
Components:Pharmaceutical products and related service、Policy，laws and governance、Regulatory system、Innovation, research and development, manufacturing and trade、Financing 、Human resource、Information
组成部分：医药产品及相关服务、政策、法律与治理、监管体系、创新、研发、制造与贸易、融资、人力资源、信息
Work together:
共事：
Policy, laws and governance：
政策、法律和治理：
The hub of coordination for the entire system and directly interacts with all system components
整个系统的协调中心，直接与所有系统组件交互
Provides the framework, structures, and systems for organizing, financing, and regulating the system, and coordinating the activities of the various institutions and stakeholders to achieve the system objectives
提供组织、融资和监管系统的框架、结构和系统，并协调各种机构和利益相关者的活动以实现系统目标
Determines the mechanisms and procedures needed to facilitate participation, transparency, and accountability, and prevent corruption and unethical practices, thereby reducing system inefficiencies and inequities
确定促进参与、透明度和问责制以及防止腐败和不道德行为所需的机制和程序，从而减少系统效率低下和不平等
Financing：The management of resources to ensure the adequate and sustainable financing of pharmaceutical product purchases, related services, human resources and other costs associated with system functioning
融资：资源管理，以确保药品采购、相关服务、人力资源和与系统运行相关的其他成本获得充足和可持续的融资
Human resource:
人力资源：
Ensures the availability of adequate numbers of appropriately trained staff for managing the supply and delivery of pharmaceutical products and related services
确保有足够数量的经过适当培训的员工来管理药品和相关服务的供应和交付
Includes policy and strategy, and personnel management and development.
包括政策和战略，以及人事管理和发展。
Information:
信息：
The generation and dissemination of timely and reliable information to support decision-making.
生成和传播及时可靠的信息以支持决策。
Essential to all components of pharmaceutical systems.
对于制药系统的所有组件都是必不可少的。
The key issues in the pharmaceutical sector (at least 3 issues, 5%) and the corresponding strategies to manage the issues (at least 3 strategies, 5%) .
制药行业的关键问题（至少 3 个问题，5%）和相应的管理问题策略（至少 3 个策略，5%）。
见第一个PPT
The different phases of clinical trials (as many as applicable, 4%) and the major differences among different phases of clinical trials (as many as applicable, 6%).
临床试验的不同阶段（如适用，4%）和临床试验不同阶段之间的主要差异（如适用，6%）。
见宋老师PPT
The importance of drug regulation (as much as possible, 3%), the key factors in the decision-making process (as many as applicable, 3%) and the possible tension between the pharmaceutical and industrial policy (at least2 examples, 4%)
药品监管的重要性（尽可能多，3%）、决策过程中的关键因素（尽可能多，3%）以及制药和产业政策之间可能存在的紧张关系（至少 2 个例子，4%）
Importance of drug regulation △是作用嘛？
药品监管的重要性 △是作用嘛？
Role:
角色：
Ensure that the benefits of drugs outweigh their risks
确保药物的好处大于风险
Reduce informational asymmetry between pharmaceutical companies and physicians and patients
减少制药公司与医生和患者之间的信息不对称
Provide additional incentives for drug development
为药物开发提供额外的激励措施
Be responsive (if not proactive) to the evolving R&D landscape
对不断发展的研发环境做出反应（如果不是主动的）
Key factors in the DM process:
DM 流程中的关键因素：
Law
法律
Policy
政策
Science
科学
Regulations influence range from our tax structure to the actions of regulatory agencies.
法规影响范围从我们的税收结构到监管机构的行动。
For example, To resolve registration backlog and improve the efficiency of drug review and approval process
例如，解决注册积压问题，提高药品审评审批流程的效率
➢ To encourage drug innovation and improve the quality of drugs
➢ 鼓励药物创新，提高药品质量
Potential tension between:
以下之间可能存在紧张关系：
The concept of quality use of medicine (5%) and the importance of pharmacist’s role in the adoption and use of pharmaceutical products (5%)
优质使用药物的概念 （5%） 和药剂师在采用和使用药品中的作用的重要性 （5%）
The concept of quality use of medicine
用药质量的理念
The major steps in dissemination and implementation science (3%), the theoretical framework of implementation(2%) science and the application of the framework for a pharmacy-related intervention (5%).
传播和实施科学的主要步骤 （3%）、实施的理论框架 （2%） 科学以及药学相关干预框架的应用 （5%）。
The major steps in dissemination and implementation science
传播和实施科学的主要步骤
the theoretical framework of implementation
实施的理论框架
science and the application of the framework for a pharmacy-related intervention 在与药学有关的干预行动中应用该框架（5%）：
Science and application of the framework for a pharmacy-related intervention 在与药学有关的干预行动中应用该框架（5%）：
CFIR：The CFIR provides a menu of constructs that have been associated with effective implementation. By providing a framework of constructs, the CFIR promotes consistent use of constructs, systematic analysis, and organization of findings from implementation studies.
CFIR：CFIR 提供了与有效实施相关的结构菜单。通过提供结构框架，CFIR 促进了结构的一致使用、系统分析和实施研究结果的组织。
PRISM：The Practical, Robust Implementation and Sustainability Model (PRISM) is an implementation science framework that considers the multilevel and dynamic interactions between the evidence-based intervention, the perspective and characteristics of diverse recipients (e.g., patients, clinicians, decision makers), the implementation and sustainability infrastructure, and the external environment (e.g., laws and regulations, clinical practice guidelines).
PRISM： 实用、稳健的实施和可持续性模型 （PRISM） 是一个实施科学框架，它考虑了循证干预、不同接受者 （例如，患者、临床医生、决策者） 的观点和特征、实施和可持续性基础设施以及外部环境 （例如，法律法规、临床实践指南） 之间的多层次和动态相互作用。
RE-AIM framework：RE-AIM is a framework to guide the planning and evaluation of programs according to the 5 key RE-AIM outcomes: Reach, Effectiveness, Adoption,I mplementation, and Maintenance.
RE-AIM 框架： RE-AIM 是一个框架，用于根据 5 个关键的 RE-AIM 结果指导计划的规划和评估：覆盖率、有效性、采用、I 实施和维护。
Precis/precis-2 Model：PRECIS-PRagmatic Explanatory Continuum Indicator Summary- is a tool to help trialists designing clinical trials consider where they would like their trial to be on the pragmatic/explanatory continuum.
Precis/Precis-2 Model：PRECIS-PRagmatic Explanatory Continuum Indicator Summary- 是一种工具，可帮助设计临床试验的试验者考虑他们希望他们的试验在实用/解释连续体中的位置。
8. The major steps in the health technology assessment (5%) and the application of HTA to inform a decision whether a pharmacy-related intervention should be funded (5%).
8.卫生技术评估的主要步骤（5%）和应用HTA为是否应资助药房相关干预措施的决定提供信息（5%）。
1)The major steps in the health technology assessment
1）卫生技术评估的主要步骤
Step 1 Identify the Topic for Assessment
第 1 步 确定评估主题
Step 2 Clear Specification of the Problem
第 2 步 明确问题规范
Step 3: Gathering the Evidence
第 3 步：收集证据
Step 4: Aggregation and Appraisal of the Evidence 【PRISMA】
第 4 步：证据的汇总和评估 【PRISMA】
Step 5: Synthesize and Consolidate Evidence
第 5 步：综合和整合证据
1.to appraise the evidence based on quality checklists or other criteria for each study according to available checklists (e.g. assessing appropriate randomization or risk of bias, the overall body of evidence)
1.根据质量检查表或每项研究的其他标准，根据可用的检查表评价证据（例如，评估适当的随机化或偏倚风险，证据的整体）。
2. to conduct a formal meta-analysis given that there is sufficient similar evidence that allows for pooling to estimate a common effect in order to estimate a summary effect, which is a weighted mean of individual effects
2. 进行正式的荟萃分析，因为有足够的相似证据允许合并来估计共同效应，以便估计汇总效应，即单个效应的加权平均值
Step 6: Collection of Primary Data (Field Evaluation
第 6 步：收集原始数据（字段评估
Step 7: Economic Evaluation, Budget and Health Systems Impact Analysis
第 7 步：经济评估、预算和卫生系统影响分析
Step 8: Assessment of Social, Ethical and Legal Considerations
第 8 步：评估社会、道德和法律因素
Step 9: Formulation of Findings and Recommendations
第 9 步：制定调查结果和建议
Step 10: Dissemination of Findings and Recommendations
第 10 步：传播调查结果和建议
Step 11: Monitoring the Impact of Assessment Reports
第 11 步：监控评估报告的影响
2) the application of HTA to inform a decision whether a pharmacy-related intervention should be funded (5%).
2） 应用 HTA 为是否应资助药房相关干预的决定提供信息（5%）。