Every day in Australia, 17 women will be diagnosed with gynaecological cancer, and of those women more than half will not survive five years. The Australia New Zealand Gynaecological Oncology Group (ANZGOG) seeks to find new ways to improve life for women through cancer research.
When the COVID-19 outbreak began, the team at ANZGOG knew they had to act swiftly and decisively to address clinical trial practice while still treating their patients.
Alison Evans, CEO of ANZGOG, said the organisation demonstrated strong leadership by bringing all ANZGOG’s Principal Investigators (PIs) together as soon as they were aware of the COVID-19 situation internationally.
“ANZGOG decision making is based on consensus and very collaborative. Our investigator group discussed the risks and issues going forward and wanted to take a decisive and proactive approach to trial management during the crisis”.
“It was agreed we wanted ANZGOG to communicate with ‘one voice’ and that our goal was to have effective guidelines that would support us working with our clinical trial sites in a really clear way,” said Ms Evans.
All ANZGOG trials remained open using the facilities that were available, and from the second half of March the Group had identified which trials would continue to recruit and which trials were considered ‘high-risk’ and therefore needing recruitment paused.
High risk trials included those with long periods for patients in chemotherapy chairs, when biopsies were required and if samples were taken for lab review, due to increased pressures on labs which had been prioritised to other work.
While low-risk trials existed where patients could take oral medications and be managed via telehealth, setting up new systems wasn’t necessarily easy. Although telehealth was a blessing for patient engagement, the set-up was very demanding.
“ANZGOG’s first priority was the well-being and safety of patients, so we wanted to do our best to ensure that all patients on a trial would continue to be treated, said Ms Evans. We worked closely with our operating centres, PIs and hospitals to achieve this.”
Recruitment for most trials was paused for two months with a review to be undertaken at the end of May. This decision was made in order to de-risk the process and avoid recruitment which couldn’t be supported effectively. By pausing recruitment, ANZGOG managed to avoid putting extra pressure on clinical trial sites.
Due to the effectiveness of ANZGOG’s approach and national COVID-19 related restrictions, ANZGOG reviewed their position at the end of April, and decided to reopen recruitment for all trials over the next six weeks. By assessing trials individually and the readiness of individual sites, ANZGOG will be able to accurately manage site capabilities.
“We’re getting enquiries from patients who really want to be on a trial, which is very different to the concerns we were hearing from patients in March. Communication by media, hospitals and state medical officers has helped to ease fears by helping patients understand how the hospital system is managing,” said Ms Evans.
The renewed interest in clinical trials is a sign of things gradually returning to normal for the team at ANZGOG. By keeping their guidelines strong, but flexible for individual cases, the trial teams have ensured the confidence of patients and hospital sites.
“We received a lovely email from one of our investigators that said they felt that the ANZGOG leadership in this was excellent, that everybody understood what was going on, direction was agreed and everyone spoke with the one voice,” said Ms Evans. “The team supporting the investigators had really followed through and kept everyone well informed, which gave confidence for this next stage of reinstating trials.”