Virtual Clinical Trials in Oncology-Overview, Challenges, Policy Considerations, and Future Directions
The COVID-19 pandemic has significantly impacted clinical research, particularly in oncology, by accelerating the adoption of virtual clinical trials. These trials can address challenges such as high costs and participant burdens associated with traditional trials.
- Virtual Clinical Trials: Utilize digital technology for things like electronic enrollment and telemedicine to improve accessibility and reduce costs.
- Advanced Analytics for Recruitment: AI-driven platforms enhance patient-trial matching, improving inclusion and reducing expenses.
- Streamlined Enrollment: Electronic tools simplify the process, reducing administrative burdens and allowing for decentralized trials.
- Decentralizing Study Touchpoints: Telemedicine and home-based product delivery improve patient convenience and access.
- Digital Data Collection: Remote monitoring and digital tools enhance data collection, providing real-world evidence for better outcomes.
The shift towards virtual trials necessitates clear regulations and infrastructure to address privacy, safety, and access disparities. This transformation is an opportunity to improve the accessibility and quality of oncology trials through digital technologies.
COVID-19 has proven to be a transformational event for medicine in the 21st century, driving rapid multi-sectoral change (eg, care provision via telemedicine and site-of-care optimization) and creating new value propositions for healthcare systems worldwide. The potential for such change is especially apparent in the clinical research enterprise, which has long been characterized by high costs, lengthy timelines, and non-representative study populations. The challenges are particularly pronounced in oncology trials because of factors ranging from illness severity (including risk of immuno-suppression), travel burden, therapeutic diversity, and regulatory complexity. Consequently, pandemic-era policy changes and delivery innovations—from regulatory flexibilities for telemedicine use to home deliveries of investigational products—provide a window to accelerate the decentralization and digitization of clinical trials. In this article, we outline an oncology-specific paradigm for virtual clinical trials, identifying the key components for study design and describing the challenges and regulatory considerations for patients, providers, and policymakers.
Click for Source
