Community Outreach and Engagement Program, Knight Cancer Institute, Oregon Health and Science University, Portland, OR, 97239, United States of America.
Oregon Clinical and Translational Research Institute, Oregon Health and Science University, Portland, OR, 97239, United States of America.
Health Res Policy Syst. 2023 Jul 24;21(1):76. doi: 10.1186/s12961-023-01030-5.
The United States' National Institutes of Health (NIH) have long challenged academia to improve clinical trial enrollment, especially in underrepresented populations; inclusive of geography, age, disability status, racial and ethnic minorities. It has been shown that rural and urban residents enrolled in clinical trials have similar outcomes, yet, rural healthcare systems struggle to provide opportunities to rural residents to participate in clinical trials when infrastructure is limited or unsupportive of research programs and/or research staffing levels are insufficient. To fully address the barriers to clinical trial access in rural areas, it is not adequate to simply open more trials. Community receptivity of research as well as organizational and community capacity must be considered. This project was determined by the Oregon Health and Science University's Institutional Review Board to be generalizable research across the chosen counties and was approved to operate under a waiver of written consent. Participants received a cash incentive in appreciation for their time and verbally agreed to participate after reviewing a project information sheet.
The research team co-created a community-responsive approach to the receipt, review, and acceptance of clinical trials in a rural community setting. An adapted 5 step Implementation Mapping approach was used to develop a systematic strategy intended to increase the success, and therefore, the number of clinical trials offered in a rural community.
The research team and participating rural community members pilot-tested the implementation of a co-designed research review strategy, inclusive of a Regional Cultural Landscape and three co-created project submission and feasibility review forms, with a cancer early detection clinical trial. The proposed clinical trial required engagement from primary care and oncology. Utilizing the research review strategy demonstrated strong researcher-community stakeholder communication and negotiation, which resulted in early identification and resolution of potential barriers, hiring a local clinical research coordinator, and timely trial opening.
To the knowledge of the research team, the work described is the first to use a community-engaged approach for creating a clinical trial implementation strategy directly supportive of rural-sitting community stakeholders in receiving, reviewing, and approving cancer-related clinical trials in their community. Participating community members and leaders had the chance to negotiate research protocol changes or considerations directly with researchers interested in conducting a cancer clinical trial in their rural setting.
美国国立卫生研究院（NIH）长期以来一直要求学术界提高临床试验的参与率，尤其是在代表性不足的人群中，包括地理、年龄、残疾状况、种族和少数民族。研究表明，参加临床试验的农村和城市居民的结果相似，但农村医疗系统在基础设施有限或不支持研究计划和/或研究人员配备水平不足的情况下，难以为农村居民提供参与临床试验的机会。为了充分解决农村地区参与临床试验的障碍，仅仅增加更多的试验是不够的。必须考虑研究的社区接受度以及组织和社区能力。俄勒冈健康与科学大学的机构审查委员会认为该项目具有所选县的推广研究价值，并批准在书面同意豁免的情况下开展项目。参与者在查看项目信息表后，获得了现金奖励以感谢他们的时间，并口头同意参与。
研究团队共同制定了一种针对农村社区环境中接收、审查和接受临床试验的社区响应方法。采用经过改编的五步实施映射方法，制定了一项系统策略，旨在提高临床试验在农村社区中的成功率，从而增加提供的临床试验数量。
研究团队和参与的农村社区成员试点测试了共同设计的研究审查策略的实施情况，包括区域文化景观和三个共同创建的项目提交和可行性审查表格，用于一项癌症早期检测临床试验。该拟议的临床试验需要初级保健和肿瘤学的参与。利用研究审查策略，展示了强大的研究人员与社区利益相关者的沟通和协商，这有助于及早识别和解决潜在障碍，聘请当地的临床研究协调员，并及时启动试验。
据研究团队所知，所描述的工作是首次使用社区参与方法来创建一项临床试验实施策略，该策略直接支持农村社区利益相关者接收、审查和批准在其社区中进行的癌症相关临床试验。参与的社区成员和领导人有机会直接与有兴趣在其农村环境中开展癌症临床试验的研究人员协商研究方案的变更或考虑因素。
