Challenges and pitfalls of running an RCT through a global pandemic: a case study in motion

Conducting an randomised controlled trial (RCT) during a pandemic is undoubtedly challenging on several different fronts, however it has also provided an opportunity to rethink how we operate and has encouraged some very creative thinking.

PEBBLES is a randomized clinical trial based in the Allergy and Lung Health Unit at the Melbourne School of Population and Global Health looking at preventing eczema and food allergy. In this study, we want to find out if infant skin management with a particular cream, called EpiCeram™, might help reduce the chances that a child will develop allergies. We recruit Melbourne families with newborn babies (up to three weeks of age) where a biological parent or older sibling has asthma, eczema, hay fever or food allergy.

The current phase of the PEBBLES study commenced recruitment in March 2018 and we now have nearly 400 participants – but require a further 360 to reach our target. To date, over 140 of our babies have completed the study.

Recruitment has always been our biggest challenge – and COVID-19 has further complicated this by significantly impacting the way in which we conduct our study. Previously we recruited participants directly from maternity hospitals and conducted baseline assessments at one of our four recruitment sites. Follow up assessments were held at the Murdoch Children’s Research Institute at six-weeks and 12-months. In mid-March, we learnt that we were no longer able to recruit directly from hospitals or conduct baseline and six-week assessments face-to-face. These restrictions happened very quickly and we soon realized that we would have to adapt accordingly if our study was to continue in this new climate. While not ideal as it would mean forgoing much of our data collection, we decided to enable online recruitment and virtual assessments for our six-week timepoint and submitted these changes to ethics.

By mid-April we received approval and commenced online recruitment. To date we have enrolled seven participants in a remote capacity and have a further 20 that are potentially interested in participating once their babies are born. We are also investigating means to further promote PEBBLES via the media channels we have available to us (and welcome any suggestions!).  We recently commenced online assessments for the six-week timepoint and these are progressing well; parents can elect to participate via zoom or photo upload. Luckily our 12-month assessments which collect end point data, are deemed essential and have continued throughout the pandemic – although some parents are understandably hesitant to attend and would prefer to postpone until restrictions are lifted.

We welcome you to contact us if you are interested in learning more about our study – as either a participant or researcher at pebbles-study@unimelb.edu.au.