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Written by Jocelyn Mora, Clinical Trial Manager, Doherty Institute

This article was first published by AustralaSian COVID-19 Trial (ASCOT).

Setting up a clinical trial can take many months, even years. However, over the last six months, research teams around the globe have been pushed to their limits to set up and conduct randomised clinical trials to the same gold standard that is expected during non-COVID-19 times, but in record time. The ASCOT team have been fortunate to have support from all over Australia and New Zealand to help us get the trial and our research sites up and running, but what does this process actually involve?

Before starting, all clinical trials need to be approved by a human research ethics committee (HREC). Preparing a clinical trial application for HREC review is by no means an easy feat. The HREC reviews the trial protocol to ensure the research is ethically acceptable and is carried out in accordance with relevant standards and guidelines. Writing the protocol involves a team of experts in the field to ensure that every test to be done and piece of information to be collected is clear and feasible, and usually takes weeks, with numerous changes and multiple versions. Whilst the protocol is in development, trial paperwork, such as the patient information sheet and consent form (PICF) and the case report forms (CRFs) need to be created. These forms let researchers collect all the information about people in the trial in ways that are the same across all the hospitals, so that we can be sure that the same standards are used everywhere.

The co-ordinating team also assemble templates for sites, such as screening logs to record everyone who might be included in the trial, and handouts for people participating. The electronic database must be built, tested and validated. Trial management committees will be formed to oversee different parts of the study. Continuous communication with the funders, sponsors, investigators, consumers and other stakeholders is crucial to keeping the trial running smoothly. The trial needs to be registered with the scientific bodies and government regulators, sites assessed and selected, principal investigators confirmed, and contracts prepared. Sourcing study drug, repackaging, relabelling, and organising distribution to sites is a huge undertaking and must be done efficiently to ensure drug is at sites in time for recruitment. With all of this progressing at the same time, it helps to have an organised team!

Receiving ethics approval is just the first hurdle, and for those working at a site level, this is when the workload starts to ramp up. Often behind the scenes are a team of research nurses and co-ordinators who ensure that the hospital has both the ability and capacity to carry out the research. These dedicated staff members ensure that all of the processes are in place to run the trial at their hospital. The site teams apply for local governance approval, which involves sites making sure that they have all the resources, staff, insurance and other requirements in place. A site initiation visit (or remote zoom session in the current circumstances) is done to make sure that staff are appropriately trained and delegated, and the co-ordinators/research nurses will begin collecting investigator CVs and Good Clinical Practice certificates - more arduous than it sounds! Pharmacies prepare for study drug delivery, and investigator site files are created. Once all approvals are in place, contracts have been signed, and drug is at site, the co-ordinating team can declare the site open for recruitment – phew!

At the time of writing, there are 14 hospitals open for recruitment to ASCOT, and many more coming on board over the next few weeks. I would especially like to say thank-you to the site PIs and staff who have worked tirelessly to ensure their site is ready to recruit- the research nurses, study co-ordinators and managers, here’s to you! No patients have been recruited to date, a sign of successful containment strategies in Australia and New Zealand, but that’s for another blog piece…