Navigating Nonessential Research Trials During COVID‐19: The Push We Needed for Using Digital Technology to Increase Access for Rural Participants?

The COVID-19 epidemic has threatened nonessential clinical trial research across the country. Now many researchers are being forced to either suspend research indefinitely, or redesign trials to conduct remote research functions from recruitment and enrollment to intervention delivery and follow-up. Moving to remote clinical trials is not without its challenges, especially for studies that are well underway. At the same time, the COVID-19 crisis provides a unique opportunity to leverage technology to increase access to and inclusivity in clinical trials in underserved areas, and specifically rural areas of the United States. Importantly, the steps we take now to continue nonessential research remotely may provide the evidence we need to ensure that future studies target these hard-to-reach populations for study inclusion. It is well known that rural populations experience significant health disparities, especially in rates of common chronic diseases (eg, heart disease, diabetes, cancer) and associated health behaviors (eg, diet, physical activity, tobacco, and other substance use). These disparities are in part due to rural residents’ lack of access to, knowledge about, and participation in clinical trials.1, 2 Thus, despite increased need for effective disease management and health promotion strategies, rural residents are frequently underrepresented in these clinical trials. There are a number of reasons why rural residents are frequently absent in clinical trials. First, most clinical trial research are conducted by large academic medical centers, which tend not to be located in rural areas. This lack of proximity to research sites contributes to some of the disparity in rural access to clinical trials.3 Second, some rural areas experience systemic barriers to remote clinical trial implementation, such as limited access to Internet-enabled mobile devices and requisite bandwidth capacity.4 Third, rural areas often have poor health care infrastructure to support clinical trials, such as lack of electronic health records, high turnover of primary providers, few to no specialty providers, and hospital closures.5, 6 Added to these barriers are the issues of research mistrust, lack of local provider buy-in to participate in clinical trials, and lack of awareness of potential benefits of clinical research.5, 7 Lastly, many trials that were designed for ongoing, in-person monitoring or biospecimen collection are not as easily translated to a remote status.8 Despite these challenges, COVID-19 may be the impetus investigators need to retool their research not only for continuity of data collection, but also for the very real benefit of being able to enroll hard-to-reach populations like rural residents. The strategies employed and validated now may be the beginning of ongoing efforts to ensure that clinical trials are more accessible to rural residents. To achieve this aim, there are several key components to address. First, it is becoming clearer every day that with thoughtful use of digital technology, study activities can be implemented remotely. For example, the authors are currently working on 2 NIH-funded (R01CA242593, R01NR017659) behavioral clinical trials that employ text-based protocols with interim assessments that can be completed virtually. When nonessential research activities restart, investigators need to carefully reconsider simply returning to the status quo of solely traditional in-person approaches and develop strategies for implementing protocols, including sample collection, remotely. Second, COVID-19 has demonstrated that when the need exists, telehealth is an effective care delivery tool that can be disseminated quickly and easily. Telephonic and videoconference clinical care approaches can be leveraged and adapted to increase access to research trials for rural populations. Third, the infrastructural challenges should be addressed through increased academic-private-public partnerships. For example, universities could collaborate with satellite Internet cooperatives to increase access to rural broadband that would support a wide range of public health and clinical care initiatives beyond clinical trial research that would benefit rural areas. Or, state departments of heath could replicate the partnership that the California Department of Education initiated with Google to distribute mobile hotspots to areas without broadband access so that K-12 education could continue amid school closures associated with shelter-in-place orders. Likewise, as academic medical centers establish accountable care organizations, they can share resources with rural partners for electronic records, care pathways, and care delivery, all of which will enhance clinical trial implementation. These partnerships and investments also will help to build trust within rural communities, and they may help to bridge the gap between local providers and researchers. Lastly, researchers should focus on innovative ways to collect biospecimens remotely and push for the adoption of more decentralized clinical trials.9 As technologies improve, this will undoubtedly be an area with significant capacity to change the way clinical trials are conducted. The COVID-19 pandemic has necessarily prompted immense creativity in addressing health care and research challenges. While we will at some point return to a “pre-COVID-19 existence,” the creativity generated from this period can and should be harnessed to continue to consider ways to reach rural and other populations who are underrepresented in research. Remote access to clinical trials has many potential benefits for rural populations, including expanding representation of people of color, native and indigenous peoples, and those living in poverty, housing and food insecurity, and with other limited resources. Researchers who were able to move to remote study activities during this time period should be encouraged to assess the “unintended benefits” of remote clinical trial study activities, rather than simply revert to traditional, in-person strategies. In fact, researchers who have moved to remote clinical trial delivery mid-study should report on comparative analyses of recruitment, adherence, accessibility, participant sociodemographics, and outcomes for remote and in-person delivery so that future researchers can learn from and adapt these strategies for future research. As a collective, researchers should continue to support the development of strategies, infrastructure, and innovations necessary to support remote participation in clinical trials so that remote access for clinical trials transitions from serving as a short-term solution to becoming a mainstay necessity in all trials whenever possible. Establishing remote access to clinical trials will serve to not only decrease rural clinical trial disparities, but also to promote rural health equity into the next decade and beyond.