证据开发

探寻支持产品价值的证据并合理地、战略性地应用这些证据是循证医学的本质所在。我们专业的证据开发团队对应用于不同目的的各类文献搜索方法均拥有丰富的经验。我们的专长包括系统性文献回顾、实用文献回顾、竞争格局分析以及基于非传统证据来源的差距分析,如利用新闻稿和制药业网站等作为信息来源

证据开发

哪些特质让我们脱颖而出?

战略咨询服务

从项目设计伊始,我们便会与客户密切合作,以确保我们的文献综述满足客户的证据需求并在预算范围内交付。我们也乐意向客户提供更加务实的系统性综述方法建议。完成证据搜索后,我们会紧密结合项目目标背景,对结果进行适切的战略性分析

严谨的方法

我们以遵循最严格的系统综述方法为荣。为 HTA 申报准备的临床、生活质量和经济信息分析,均依照申报流程规范及模板的要求进行;快速文献综述与实用文献综述同样注重方法的透明与可重复性

透明准确的预算,绝无隐藏费用

我们在提案阶段即会投入较多工作,研究确认所需搜索与分析的规模;我们为客户提供的预算均基于实践过的搜索策略。 我们致力于优化项目流程的效率,并开发了多种有助于实现流程自动化的工具。我们在 2015 年 Cochrane 学术讨论会上发表过创新机器学习方面的研究,如欲获取更多相关信息,请联系 Ma Qian 马茜

广泛的内部协作

我们的证据开发团队与公司内的其他专业团队密切合作,确保项目的任何后续阶段 (如荟萃分析HTA 申报价值材料医学写作) 都能获得相关领域专业团队支持

案例展示

系统性文献回顾

We were approached by a client to conduct a systematic literature review and meta-analysis on the risk of adverse health outcomes associated with substance misuse, in order to support the value communication of a novel pharmacological therapy in this disease area.

Throughout the project, we provided strategic leadership to ensure that the review was conducted to the highest academic standards as well as being targeted to the client’s needs. For example, the thorough scoping we conducted at the proposal stage identified that the evidence base for the topic planned was extremely large. In order to maximise the ability of the review to identify all relevant studies within the client’s required timelines, we recommended focusing the topic area of the review on a single adverse health outcome of particular importance. This recommendation was approved by the client and allowed the development of highly sensitive search terms for the review.

The review was conducted using the most stringent methodology recommended in the Cochrane Handbook for Systematic Reviews of Interventions and by the University of York’s Centre for Reviews and Dissemination. Two reviewers independently screened the articles at both the abstract and full-text review stages, and resolved any disagreements regarding the eligibility of an article by discussion until a consensus was met. Comprehensive hand searches of the bibliographies of included articles were also conducted in order to identify further potentially relevant studies for inclusion in the review. As we strongly believe that assessing the quality of studies included in a systematic review is essential, we identified a relevant, detailed and recently published quality assessment form and tailored it to align with the objectives of our systematic review. We then applied the quality assessment to each included study in order to remove any studies that were not credible from the meta-analysis.

As well as involving a large number of articles, the review was highly complex as it included observational studies published over a period of more than fifty years. The terminology, understanding and reporting of the disease area have evolved considerably over this time period leading to high heterogeneity between studies. We were able to use our expertise and insight into the disease area to make informed decisions on which studies met our eligibility criteria, and to produce an insightful written analysis of the results. The client was delighted with our clear and thorough report.

We subsequently collaborated with the client, an external author, and Costello Medical’s Publications Division to prepare the results for publication, in line with the PRISMA and MOOSE reporting guidelines for systematic review and meta-analyses.

战略性证据搜索

We were asked by a client to conduct a series of literature searches to identify published data, future studies and the views of key opinion leaders on a number of topics of interest to support the strategic positioning of a drug due to enter Phase III development.

The project had three key objectives: to identify the most pertinent data in an efficient but rigorous manner; to record the search results comprehensively in a format that could be updated in the future; and to provide a visual summary of the key findings from these searches for internal alignment purposes and to support conversations with key opinion leaders.

To address the first objective, we defined in collaboration with the client a series of strategic evidence searches for publications, congress abstracts, clinical trials, treatment guidelines and articles posted on commercial and pharmaceutical news websites, adjusting the search terms until a suitable balance between sensitivity and specificity was reached.

We developed interactive Excel trackers to document each search and to provide a comprehensive library of the search results. The trackers included illustrative summary metrics of the searches and all search results were classified by their source and assigned relevance scores so that relevant items could be located easily.

We subsequently evaluated the search results to address specific questions from the client, as well as to identify key trends in the data with a focus on unmet patient needs and gaps in the current treatment paradigm. We conveyed our findings in a PowerPoint presentation using a combination of summary diagrams and more detailed descriptions of important studies.

The feedback from the client was overwhelmingly positive, with the results of the searches used to inform advisory board discussions and the project evolving to include further topic areas and periodic updates across all topic areas.

多语种文献回顾

To inform a global value dossier for a product currently in Phase III development, we conducted a number of literature reviews to characterise the global humanistic burden of disease as well as identifying clinical and economic data in support of the client’s drug and its key competitors.

The scope of the project was broad, both in terms of the research questions posed and the markets of interest to the client. We therefore developed a multi-stage approach which began with pragmatic literature reviews in English to characterise the burden of disease. This helped to build a comprehensive understanding of the treatment guidelines and key competitors. The next stage comprised two systematic literature reviews to identify clinical and economic evidence for the drug and its competitors. These searches queried standard electronic databases in English as well as comprehensive searches of Japanese and Chinese databases in collaboration with our Asia team, as the client had identified Japan and China as key markets of interest.

Search terms for the disease area were developed de novo in English. These were then adapted for use on the Japanese platform Ichushi Web [医中誌Web], which indexes numerous databases including CiNii and J-Stage. The terms were also adapted for use on the following Chinese databases: China National Knowledge Infrastructure (CNKI) [中国知网], Wanfang Data [万方数据库] and Chongqing VIP Information [VIP 维普网]. Consistency between the individuals reviewing in English and Japanese was established by the use of matching eligibility criteria for both languages and regular alignment meetings to ensure that the inclusion of studies was consistent across all data sources reviewed.

The results were then extracted by the review teams directly in English, as per the client’s preference for this particular project. We then created a comprehensive evidence inventory, which comprised details of all included studies and the sections of the value dossier that each study helped to inform.

With the inclusion of evidence from English language databases and those specifically from Japanese and Chinese databases, this broader perspective for the value dossier minimised the risk to the client of needing to commission further country-specific updates at a later date and ensured that all the relevant data were captured and synthesised simultaneously by our experienced multi-lingual team, leading to a cohesive and consistent global value dossier for the product.

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