The challenges of cancer clinical trials in the pandemic: one unit’s experience


By Mardi Chapman

15 Apr 2021

The COVID-19 pandemic has pushed cancer clinical research teams into being more adaptable and led to changes such as telehealth assessment that may become permanent.

A report from the Cancer Care Services Clinical Research Unit (CRU) at the Royal Brisbane and Women’s Hospital has documented the experience of the unit between March and September 2020.

The CRU was able to continue most of its research activity (186 of 202 studies) with only eight studies paused by the unit and eight closed by the sponsors due to the pandemic.

“The haematology and BMT group did not formally suspend recruitment to any study, instead focused recruitment on patients with acute disease who would most benefit from participation in a clinical trial,” the report said.

While patient recruitment dropped quickly in March 2020 – down almost 55% compared to March 2019 – it recovered quickly by May 2020 before dropping back again in June-July.

As reported elsewhere, the pandemic drove a speedy transition to telehealth that may otherwise not have occurred. Most telehealth at the unit was telephone consults rather than video conferencing.

“Prior to the pandemic, clinical trial telehealth had not been possible for two key reasons: it did not meet protocol‐specific assessments mandated to be conducted on site, and it was not endorsed by Medicare or Queensland Health.”

The article, published in the Asia-Pacific Journal of Clinical Oncology, said the pandemic had in fact provided an opportunity to consider incorporating lasting changes into routine practice.

“For example the Australian healthcare system has embraced the use of new IT solutions, including telehealth, more swiftly than it would have otherwise. This is of particular relevance in locations such as ours which are characterised by vast geographical areas with low population density.”

“Future clinical trial designs could incorporate opportunities for telemedicine (‘Teletrials’) where practical to reshape participant safety assessments and allow off‐site assessments as part of the trial protocol.”

It said sponsors became more flexible during the pandemic and research became more patient focussed.

“Patients who live in regional areas have been allowed to have assessments performed with their local medical practitioner, local laboratory, or local imaging provider with the CCS CRU staff and investigator oversight. The impact of this on trial outcome evaluation and data collection will be assessed, but if feasible could provide convenient alternatives for future trial conduct.”

Senior author Dr Natasha Roberts, from Cancer Care Services at the Royal Brisbane and Women’s Hospital and the University of Queensland Centre for Clinical Research (UQCCR), told the limbic that clinical trials were so heavily regulated that research units have not tested boundaries before.

She said flexibility, collaboration and the quality of preexisting relationships both internally and with sponsors were critical.

For example, sponsors relied on the judgment of the principal investigators rather than being directive about trial changes during the pandemic.

Dr Roberts, a prostate cancer specialist nurse and Metro North research fellow, said the transition to telehealth was likely to persist in some form beyond the pandemic.

“Every now and then we start getting people back in and then we have a lockdown and we swing back fairly quickly. I think it’s our new normal.”

“It’s definitely something that will be staying around but … there needs to be further knowledge built around the use of telehealth rather than just assuming it is working and is as effective as seeing a patient in person.”

“Our experience of telehealth was phone based but that wasn’t the case across Australia. A lot of units actually went to video conferencing and those forms of telehealth.”

Dr Roberts said the response to the challenge of COVID-19 was driven by more than just practicalities.

“The ethical component that was driving it was that we didn’t want people to miss out on getting their access to treatment, and that was something that patients were very concerned about.”

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