It is scary enough being treated for COVID-19 – why would a patient also consider being part of a research trial?

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 COVID-19 isolation ward is a somewhat surreal place. Most patients are cared for in a single room and cannot have visitors, as there is a great risk of friends and family also becoming infected after visiting. Most patients who need to be admitted to hospital feel quite unwell. Often with fevers, breathlessness, and cough, and occasionally with some other distressing symptoms such as chest pains, diarrhea, and even intractable hiccups.

All staff entering the room are covered in personal protective equipment (PPE), which includes a surgical gown, gloves, a tight-fitting face mask and a face shield. Not surprisingly, patients may not find it easy to connect with hospital staff. Voices are muffled by the layers of PPE, facial expressions are hidden behind masks and the uniformity of dress makes it difficult to distinguish one staff member from another.

It is here on the isolation ward that patients may be offered participation in a clinical trial such as ASCOT. Patients may already feel disoriented in this strange environment, shunned, and separated from the rest of the hospital population. Deciding to participate in a clinical trial may be daunting if you are unable to talk it over in person with family and friends.

Offering participation in a clinical trial requires a change in communication style for the medical team. Rather than being able to confidently reassure the patient that the best effective treatments will be delivered, there must be a confession that for this illness there is a limitation of medical knowledge and treatment options. Doctors can only say, “We don’t know the best treatment for this condition, we believe these experimental therapies may help, but we can only find out for sure with proper observation”.

For a new disease such as COVID-19, the current medical knowledge is very limited. The current treatment options, such as the anti-viral remdesivir and the anti-inflammatory dexamethasone, are few and only partially effective. Several therapies which showed initial promise have subsequently been found to be ineffective and occasionally harmful in properly conducted trials.

So why would patients still choose to participate?

For most medical conditions, the best treatments currently available  have been previously tested in  clinical trials, to help the medical community not only learn about the effectiveness of treatments, but also their potential side effects. This important step in the process of finding treatments for diseases, including new diseases like COVID-19, requires the participation of many different types of patients. Without it, new and potentially lifesaving treatments cannot properly be determined. Whilst patients feel understandably cautious about trying new therapies, the safest way to do so is under the careful observation of a clinical trial within a hospital.

Patients have a right to choose to be involved in finding and trying new treatments; in many ways this may be the best form of autonomy that can be offered to them. Patients certainly do not choose to have COVID-19, they do not choose to be isolated from their loved ones, but they can choose to help find a better treatment. When they make this informed choice, they are no longer patients but participants, participating in the journey of discovery and part of the solution.