OBJECTIVES: The COVID-19 pandemic has demonstrated the need to think innovatively in the design and conduct of real-world studies to ensure study continuity with minimal burden imposed on healthcare personnel. Virtual and technology-driven solutions are available, but wide acceptability and adoption have been slow. We describe opportunities and challenges with incorporating different virtual and digital solutions, and how they can be successfully integrated into different study designs.

METHODS: Qualitative assessment of the conduct of virtual de-centralised study designs and the use of technology to extract data from hospital EMR systems. Observed opportunities and challenges are delineated. Applied virtual and technology-driven solutions were evaluated based on receptivity for study incorporation, ease of implementation and success factors such as accuracy, reliability, and the ability to complete the studies on time.

RESULTS: Several types of virtual and technology-driven solutions can be implemented across a number of study designs as primary and/or risk mitigation study execution strategies. Opportunities included: reduced workload/responsibility of hospital staff, increased data accuracy and speed of collection, increased patient adherence and reduced burden, increased control over study delivery with reduced impact of extraneous factors. Challenges included: Slow adoption of novel approaches, delayed ethics/release of data approvals for studies that do not fit typical traditional approach, country requirements that impact ability to implement, not all EMR systems are compatible, and linkage across several data sources may be required.

CONCLUSIONS: Virtual and technology-driven solutions can be successfully implemented to address a breadth of research questions pertinent to drive drug approvals and improve patient care. Given the variety of options available and the need to tailor solutions to specific study needs, pragmatism is necessary to ensure successful shift from traditional to virtual.