Helping Rural Cancer Clinics Maintain Compliance, Security in Clinical Trials
Rural oncology clinics are overcoming longstanding clinical trial barriers with support from the Duke Cancer Network. Through secure digital tools, strategic training, and real-time quality oversight, Duke Cancer Network enables community hospitals to safely and effectively run trials close to home.
Challenge
While overall cancer rates in the United States are declining, rural communities—particularly in the South—continue to experience higher five-year incidence rates. Accessing care locally helps patients avoid costly, time-consuming travel and keeps them close to their support systems. However, delivering advanced treatments like clinical trials remains a challenge for many rural hospitals.
“A clinical trial is a great way to access treatments five to 10 years before FDA approval,” says DCN research nurse program manager Catrin Davies, PhD, BSN, RN. “It can be a three-hour, one-way trip to Duke’s main campus for these patients unless there is an option for trials to be offered locally.”
Solution: Facilitating Clinical Trials
For more than two decades, the Duke Cancer Network has partnered with rural community-based hospitals to help them participate in clinical trials. Through this affiliation, these hospitals can now offer clinical trial options closer to home, expanding access to alternative treatments.
DCN clinical research associate Donna Allen, BSN, RN, OCN, agrees. “Our goal is to get research to rural communities where they otherwise wouldn’t have access, making treatment more feasible and realistic.”
Managing a clinical trial’s frequent documentation updates and transmitting those documents through a HIPAA compliant mechanism remained a challenge for Duke Cancer Network affiliates. Additionally, the clinics needed to streamline research processes to ensure strong internal quality assurance while also safeguarding sensitive information.
The Duke Cancer Network Team selected a secure, HIPAA-compliant web-based application to create a platform for collecting, managing, and analyzing research data efficiently and securely streamline processes and enhance efficiency. The application facilitates rural oncology clinics’ access to research tools and resources, study training, regulatory and research documents, while improving communication, and supporting the performance of high-quality research.
“To facilitate the remote oversight of research activities, we developed an eBinder to replace traditional paper documents and provide easy access to essential research tools, regulations, guidelines, and protocol-specific documents, say Davies. “This technology enables us to send eBinders to clinical research staff securely, providing all the documents the clinic needs, as well as a secure method to manage and transmit the completed documents back.”
Similarly, Duke Cancer Network uses this application to send clinics Quality Assurance (QA) review links, facilitating the performance of QA reviews of research activities in real-time. Clinic staff upload the required documents for review, promoting timely communication of research activities and enabling DCN to offer feedback, resources, and education to support the affiliate in building and sustaining a successful research program.
“The platform has offered great flexibility as a tool for onboarding new affiliate sites, providing study education, accessing key research documents, completing QA reviews, and more,” says Allen.
Outcome: Simplifying Clinical Trial Access for Rural Community Hospitals.
Using a secure web application, Duke Cancer Network has improved rural oncology clinics’ clinical trial participation by
- streamlining research activities
- ensuring accurate, consistent study conduct and documentation
- enabling secure document upload and organization
- enhancing communication and reducing workload
- supporting QA and real-time deficiency correction
- promoting quality research and audit readiness
“For new sites, this enhances our ability to extend the guidance and assistance needed to establish a strong research program,” says Allen. “For sites with prior research experience, we can effectively communicate the more detailed aspects of each study, offer oversight, and perform real-time quality checks to ensure ongoing success and audit readiness.”