STAYING AFLOAT - COORDINATING A PREGNANCY RANDOMISED CLINICAL TRIAL during A GLOBAL PANDEMIC

ABSTRACT

Background: The COVID-19 pandemic affected numerous global industry sectors. Impacts on pre-existing randomised clinical trials, however, have largely been unaddressed. The Perth-based Preterm Birth Prevention Study (PTBPS), a trial assessing a new microbial DNA test and treatment regimen for prevention of preterm birth, was plunged into uncertainty two years into recruitment, and had to rapidly adapt to a constantly changing environment to survive. Method(s) Recruitment was moved from patient-facing to telephone and internet. Study information was included in antenatal mailouts in place of antenatal visits. Sample collection predominantly occurred off-site, in many cases from participant's homes. Where necessary, study medications were delivered to participants. Additional funding was sought and additional study sites were added. Result(s) COVID-19 associated restrictions and later, dissemination of COVID-19 into the Western Australian community, badly impacted study recruitment. Financial burden was high;the initial national lockdown alone cost the project $71 590. Two philanthropic donations and a state government grant allowed trial continuation, ensuring a sufficiently powered interim data analysis will occur at the end of 2023. Using a combination of adaptive recruitment methods (e-recruitment and off-site participant consultations), combined with two additional study sites, trial recruitment continued throughout the majority of the pandemic, albeit at a greatly diminished rate. Conclusion(s) The PTBPS was one of many NHMRC-funded clinical trials impacted by the COVID-19 pandemic. Unlike many others, it was fortunate enough to continue operating during times of uncertainty through a combination of philanthropic and state government generosity and protocol changes to match the dynamic clinical environment.