Navigating Complexities In Randomized Trials: Insights From The EMERGE Trial Amidst Pandemic And Cybersecurity Threat

Introduction: The COVID-19 pandemic caused by the SARS-CoV-2 virus changed the global landscape of clinical trials; changes in staffing, clinical priorities and recruitment challenges led to the delay or termination of many clinical trials. The Early Metformin in Gestational Diabetes (EMERGE) trial was completed despite COVID-19 and institutional computer network attacks (CNAs). Methods: Here we outline the challenges encountered and the solutions employed to continue the active recruitment of a potentially high risk patient cohort during the Covid-19 pandemic and detail the techniques adapted to enable recruitment, adverse event reporting and lab reporting during two critical computer network attacks. We present our solutions from both the site and sponsor perspective. Results: COVID-19 and the computer network attacks presented many challenges for the clinical trial site and Sponsor including staff shortages, remote working, deferred recruitment, changes in the diagnostic pathway for gestational diabetes mellitus and pivoting to remote working and telemedicine. The first CNA impeded clinical and laboratory systems, impacting recruitment and follow up. The second CNA delayed access to the Clinical Data Management System. Solutions employed included telemedicine, videoconferencing, shortened in-person reviews, contact tracing, COVID-19 risk mitigations, paper-based back-up systems and vigorous data integrity checks. Conclusion: Overcoming the multiple challenges posed by COVID-19 and computer network attacks required rapid re-organisation, teamwork and flexibility from staff and Sponsor. The use of both digital solutions and paper-based records highlighted the importance of rapid innovation and comprehensive protocol planning.