Decentralized Trials and Data Sharing Initiatives Aim to Bridge Cancer Care Gap in Rural Areas
核心洞察
Decentralized clinical trials, leveraging telehealth and home-based services, are emerging as a key strategy to improve access for rural cancer (搜索) patients.
Increased remote monitoring and direct-to-patient drug delivery, expedited by COVID-19 adaptations, have shown promising results in boosting rural trial enrollment.
Collaborative data-sharing initiatives like the CARDS group are enhancing cancer (搜索) centers' ability to identify and address disparities in rural catchment areas.
Investigators are actively exploring and implementing innovative strategies to address the persistent challenge of limited access to cancer (搜索) care for patients residing in rural areas. These efforts include programs designed to increase clinical trial enrollment and enhance patient catchment area data sharing among institutions.
Decentralized Clinical Trials: Bringing Care Closer to Home
According to Ramya Thota, MD, a medical oncologist at Intermountain Health (搜索), patients in rural areas often lack access to specialized oncologists and essential resources such as survivorship programs, supportive care, and genetic counseling. The incorporation of clinical trials into rural care can be particularly burdensome due to travel and childcare costs associated with frequent visits.
Decentralized clinical trials, which utilize online consent forms, home delivery of investigational products, and mobile technology for patient monitoring, are gaining traction as a solution. These trials also facilitate local laboratory work, imaging, and standard-of-care infusions, reducing the need for travel to larger centers. "The goal and emphasis are on bringing clinical trials closer to patients’ homes," Thota stated.
The COVID-19 pandemic accelerated the adoption of decentralized approaches, with the FDA and NCI adapting procedures to include remote electronic patient consent, telehealth visits, and direct-to-patient drug shipments. A study from the Alliance Clinical Trials Network indicated that rural patient enrollment in clinical studies increased during the pandemic years of 2020-2022, particularly at NCI Community Oncology Research Program sites.
A 2021 survey of the Rural Health Sub-Committee (RHSC) of the Alliance Clinical Trials Network Community Oncology Committee revealed that 73% of respondents reported an increase in rural patient enrollment in trials from pre-COVID-19 levels. Remote consent (44%) and visit requirement adaptations (37%) were identified as the most impactful process changes. However, challenges such as limited broadband connectivity and digital literacy among patients remain.
To sustain the gains made during the COVID-19 era, the RHSC has proposed clinical trial design considerations to ease the burden on rural patients, including classifying participant rurality, minimizing repeat imaging, allowing remote consent, using telehealth and mobile technology, offering financial support, and emphasizing local care delivery and recruitment strategies.
Refining Catchment Area Data Sharing
Another factor impacting cancer (搜索) care access in rural areas is the self-determination of catchment areas by NCI-designated cancer centers. While many centers use geospatial data to understand disparities and inform prevention efforts, these efforts are often independent, limiting their impact.
To address this, investigators from multiple institutions formed the Catchment Area Research and Data Science (CARDS) group in 2022. The aim of CARDS is to foster collaboration among investigators involved in cancer (搜索) center catchment area data collection, analysis, and use, to streamline efforts to provide care to underserved populations.
Todd Burus, MAS, a founder of the CARDS group and a data visualization specialist at the University of Kentucky (KU) Markey Cancer (搜索) Center, noted that many institutions were duplicating efforts in performing surveillance of the cancer burden in their catchment areas. The CARDS group aims to develop best practices, efficiency measures, and resource sharing to reduce duplication.
In 2018, the KU Cancer (搜索) Center created the Organize and Prioritize Trends to Inform KU Cancer Center (OPTIK) program, which includes a database and data visualization applications. Researchers use OPTIK to examine demographic, screening, risk factor, cancer incidence, and cancer mortality trends within their catchment area. Building on OPTIK, researchers at the KU Markey Cancer Center developed the Cancer InFocus data gathering and visualization platform, which automates the collection of catchment area data.
The Cancer (搜索) InFocus software has been licensed by 26 cancer centers and 1 state cancer registry as of May 2024. Burus explained that the software allows investigators to map gastroenterologists and colon and rectal surgeons, overlaying this information with colorectal cancer (搜索) screening rates to identify areas of greatest need. This enables targeted outreach efforts to improve screening rates in underserved rural areas.