真实世界证据

Costello Medical 深知在产品生命周期内利用真实世界证据 (RWE) 向关键利益相关方展示药物/医疗技术临床价值及经济价值的重要性。综合临床医学、流行病学和统计学专业知识,我们利用多种数据源开展高质量的真实世界研究

真实世界证据

我们的专长

差距分析、数据现状分析和策略支持

我们通过开展缜密的差距分析、选择最合适的数据源,生成证据填补这些缺口。我们所有的 RWE 项目都是从零开始;我们没有专有数据源,因此可以根据您特定的证据要求制定研究和分析方案

研究方案及分析方法制定

项目伊始,我们会组建一支包含疾病专家、流行病学分析师和统计分析师在内的核心项目团队,按照国际药物流行病学学会 (ISPE)《优良药物流行病学规范(GPP)指南》要求,制定严谨且恰当的真实世界研究方案,以满足证据需求。我们的分析方法完全透明,将全面描述从数据清洗到终版统计模型中的每一步细节。需要时,我们亦可为伦理审查委员会或机构审查委员会 (IRB)准备所有审批材料,并在此过程中承担完整的项目管理角色

多种数据源分析

我们可以分析多种来源的数据,包括:

  • 医疗保险理赔数据库
  • 电子病例数据库
  • 疾病登记研究
  • 患者、医师或看护者调研
  • 临床及经济学结局研究
临床及经济学结局研究

我们开展过疾病自然史、疾病临床和经济负担、治疗现状及治疗结局方面的研究,了解在真实世界数据源中开发和验证算法来识别特定条件或事件的难度。为此,我们将与客户和外部专家密切合作,确保每一步分析均具有临床相关性

案例展示

利用保险理赔数据库进行风险分析

We designed, conducted and reported an analysis of a large claims/EMR database to explore the risk of a recurrent clinical outcome in patients who had already experienced one event. We prepared the full protocol and analysis plan (including seeking clinical validation of key definitions), dual-programmed the analysis, performed survival analysis and logistic regression to explore the risk factors associated with recurrence of the outcome, and presented our findings in a detailed report that met STROBE reporting guidelines.

患者及医生调研

We conducted two surveys (one for patients and one for clinicians) exploring medication adherence, patient-reported outcomes and cost of illness. We started with a targeted literature review and gap analysis, and designed the survey to fill the identified gaps. Content and wording of the survey were designed in collaboration with clinical experts and patient organisations. We also supported the application for ethics review, recruitment of patients, distribution of the survey, statistical analysis, and developing a suite of publications. The results were used as cost-utility inputs model inputs for NICE submissions, and we have developed lay summaries that will be shared on patient organisation newsletters, websites and social media.

罕见疾病登记研究分析

We supported an investigator-initiated retrospective analysis of clinical outcomes collected by a registry of patients with a rare disease. This involved using novel techniques to account for the limited dataset, analyses to assess the appropriateness of the current gold-standard clinical composite outcome measure, and development of a manuscript to communicate the results.