Development of Clinical Trial Matching Engine Technology to Accelerate Participan

描述（由申请人提供）：进行和完成临床试验依赖于成功招募足够的患者志愿者，这些志愿者与任何给定的研究是适当匹配的。 Corengi, Inc. 开发了一个技术平台，支持专用网站，该网站具有匹配引擎和临床试验目录以及可由第三方在线嵌入的随附小部件。目的是使个人能够快速确定他们可能有资格参加的地理位置相近的试验。目前的重点是 2 型糖尿病 (T2D)，但可以增强这些工具以涵盖其他疾病/病症。 加快临床试验参与者招募是一项重要的公共卫生目标，特别是 NCRR 在 NIH SBIR 综合征集中将其列为感兴趣的研究主题。对于 SBIR 第一阶段资助，Coregi, Inc. 提议创建新的类似临床试验匹配引擎。 第一个组成部分是确定 3 到 5 种疾病/病症，为其创建新的临床试验匹配引擎。这将通过进行调查和访谈研究以及分析公共数据来完成。结果将用于确定最适合匹配引擎的特定疾病/状况。对 ClinicalTrials.gov 上可用试验范围的分析也将有助于确定最佳候选者。 第二个组成部分是新的类似匹配引擎的设计、编程和发布。这些努力将建立在 Corengi 团队开发 T2D 引擎的经验之上。将为每个新引擎设计一份普通患者可以使用并能有效筛选每种疾病/病症试验的医学调查问卷。将开发基于 ClinicalTrials.gov 的试验信息的新数据导入流程，并对每个试验的标准文本进行数据挖掘并编码适当的算法。至此，新的匹配引擎就完成了。 第三个组成部分是公开发布新应用程序，分析由此产生的网站指标/用户响应，并确定商业化潜力。新闻稿、社交媒体整合、搜索引擎和社交网络营销将用于提高匹配工具的知名度。有关新引擎的研究和反馈将与 T2D 的初步工作相关联。 Corengi团队已经展示了其提供强大的T2D临床试验匹配引擎的能力，该引擎受到了在线糖尿病社区和受众的好评。该公司已在将该产品商业化方面迈出了成功的第一步。基于该公司迄今为止所取得的成功以及公众健康对招募患者志愿者以推进医学研究的持续需求，NIH 将非常适合为该 SBIR 第一阶段拨款提案提供资金。 公共卫生相关性：Corengi, Inc. 开发了一个技术平台，其目的是使个人能够快速识别地理上接近的试验，他们可能会 合格，支持专用网站，该网站具有匹配引擎和临床试验目录以及可由第三方在线嵌入的随附小部件。目前的重点是 2 型糖尿病，但可以增强这些工具以涵盖其他疾病/病症。该项目提案旨在确定可能适合类似在线治疗的其他疾病/病症 资源、规划新应用程序，并通过将更广泛的患者与临床研究联系起来来分析其对临床试验招募的影响。

DESCRIPTION (provided by applicant): Conducting and completing clinical trials relies on successful recruitment of enough patient volunteers, who are appropriate matches, for any given study. Corengi, Inc. has developed a technology platform that supports a dedicated website with a matching engine and clinical trials directory and accompanying widget that can be embedded online by third parties. The purpose is to enable individuals to quickly identify geographically close trials, which they may be qualified for. The current focus is on Type 2 diabetes (T2D) but the tools can be enhanced to cover other diseases/conditions. Accelerating participant recruitment for clinical trials is an important public health goal that is specifically called out as a research topic of interest by the NCRR in the NIH SBIR omnibus solicitation. For this SBIR Phase 1 grant, Corengi, Inc. proposes the creation of new analogous clinical trial matching engines. The first component is to identify 3 to 5 diseases/conditions for which to create new clinical trials matching engines. This will be done by conducting survey and interview research and analyzing public data. The results will be used to determine the specific diseases/conditions optimally suited for a matching engine. An analysis of the universe of available trials on clinicaltrials.gov will also help determine the best candidates. The second component is the design, programming, and release of the new analogous matching engines. These efforts will build upon the Corengi team's experience in their development of the T2D engine. A medical questionnaire that the average patient can use and is effective at filtering the trials for each disease/condition will be designed for each of the new engines. New data import processes for the clinicaltrials.gov-based trial information will be developed and the criteria tex for each trial will be data mined and the appropriate algorithms coded. At this point, the new matching engines will be completed. The third component is to publicly release the new applications, analyze the resultant website metrics/user responses, and determine the commercialization potential. Press releases, social media integration, and search engine and social network marketing will be used to increase awareness of the matching tools. Research and feedback about the new engines will be correlated with the initial work done with T2D. The Corengi team has already demonstrated its ability to deliver a powerful T2D clinical trial matching engine, which has been well received by online diabetes communities and audiences. The company has taken successful initial steps in commercializing this product. Based on the firm's success to date and the ongoing public health need for patient volunteer recruitment to advance medical research, the NIH would be well- served to fund this SBIR Phase 1 grant proposal. PUBLIC HEALTH RELEVANCE: Corengi, Inc. has developed a technology platform, whose purpose is to enable individuals to quickly identify geographically close trials, which they may be qualified for, that supports a dedicated website with a matching engine and clinical trials directory and accompanying widget that can be embedded online by third parties. The current focus is on Type 2 diabetes but the tools can be enhanced to cover other diseases/conditions. This project proposal is to identify other diseases/conditions that may be suited to similar online resources, program the new applications, and analyze their impact on clinical trials recruitment by connecting a broader range of patients with clinical research.