Rapid Protocol Development, Study Startup and Enrolment of a Prospective Study of COVID-19 Vaccination for Patients with Cancer: A Collaborative Approach

Abstract

Background: COVID-19 is an unprecedented global health emergency. It has been highly disruptive for patients with cancer, both due to an increased burden of severe illness and due to pressure on healthcare systems. COVID-19 vaccination has been an important public health measure for this patient group. Aim: The aim of this study was to describe the rapid design and startup of a multicentre study of COVID-19 vaccine response for vulnerable patients with cancer. Study startup: We set up a multicentre prospective observational study of COVID-19 vaccination response for Australian patients with cancer. Due to intensive collaboration between health services, the funding body and laboratories, we were able to develop a protocol and enrol the first patient within 52 days of the initial study proposal. Rapid startup was further enabled by prompt availability of funding and by high-level engagement of institutional review boards, allowing expedited review. Study enrolment: We rapidly enroled more than 500 patients, 80% within 4 months of study opening. Engagement and follow-up were maintained throughout the course of up to five serial vaccination doses. Conclusion: Our study is an example of intensive collaboration inspired by the COVID-19 pandemic and may serve as an example of an agile research response to real-time public health challenges.

Keywords

• COVID-19
• SARS-CoV-2
• cancer
• study startup
• protocol development
• vaccination