Standard of care explained
Written by Dr Megan Rees, Chief Investigator, AustralaSian COVID-19 Clinical Trial, Respiratory and Sleep Physician, Royal Melbourne Hospital and Nanette Trask, Consumer Representative on the AustralaSian COVID-19 Clinical Trial Steering Committee.
The experimental therapies offered in a clinical trial are often compared to the ‘standard of care’ or the usual current practice. In a research study, one would not want a participant to miss out on any therapies that would be usually given so a new intervention is often compared with a standard or commonly used intervention that is already known to be helpful. This makes it possible to determine whether the new intervention works better than one that is already being used.
What the standard of care may comprise is usually not specified in a particular study and at first glance, may seem anything but standard, as it often differs between locations and evolves over time.
The standard of care may vary between locations due to the available care in each location. For example, in the early stages of the COVID-19 pandemic there may be an abundance of staff and equipment available, which may become more restricted at the peak of an epidemic. We have been fortunate in Australia and New Zealand with case numbers well below the system capacity to date. As a result, a COVID-19 patient in Australia who did not yet require a ventilator could be admitted to ICU for close observation in the early part of their illness. This would have been impossible in Northern Italy during their first wave of COVID-19, when there was not enough ICU beds or ventilators in the regions, and patients were transferred to different regions of the country for care.
The standard of care may vary over time as new research evidence emerges of the benefits or harms of various treatments. Although the COVID-19 pandemic is a new phenomenon present for less than a year, some significant changes in the standard of care have already occurred. The more notable of these has been the introduction of corticosteroid anti-inflammatory medications for patients with severe illness requiring oxygen or even breathing support on a ventilator. Initially, this was a controversial area with some small studies observing potential harm with the addition of corticosteroids, however once the large and well-constructed RECOVERY trial was able to demonstrate the benefit of dexamethasone to patients receiving oxygen, it was adopted by national guidelines, as well as standard of care practice in most hospitals.
So how does a clinical trial account for differences in standard of care between sites and over time? In a multicentre and multinational trial such as ASCOT, the research team will randomise patients so that half receive the experimental therapy in addition to standard of care, and the other half of patients receive the standard of care only. Thereby the standards themselves don’t need to be exact as long as each individual site at a particular time gives the same standard of care to participants receiving the experimental therapy as those having standard of care alone. The details of the standard of care given to participants in both groups are recorded and later checked when the trial results are analysed to ensure there was no bias.
Consequently, patients participating in a trial receive the same quality of care as they otherwise would have – whether they receive standard of care or the experimental therapy plus the standard of care – both under careful observation and support of medical professionals. The added benefit of participation - being part of the process of finding the treatments that will become the standard of care in the future.