Oncology tele-trials model is robust and responsive
COSA has reported on the pilot implementation of the Australasian Tele-Trials Model to enable rural and regional cancer patients access to clinical trials.
The report said the Tele-Trial Model can be safely and ethically applied to clinical trials for any disease and any type of clinical oncology research including psycho-social research, and medical device research.
The pilot involved five primary sites and 14 satellite sites in NSW, Queensland and Victoria.
While COVID-19 resulted in some delays to recruitment in 2020, it also highlighted the advantages of tele-trials.
“The response to the pandemic resulted in greater collaboration across clinical trial organisations, increased responsiveness and flexibility of HRECs and RGOs, and fostered an environment of collaboration and cooperation between key stakeholders all of which facilitated the progress of tele-trials within Australia,” the report said.
It said hosting clinical trials at large regional cancer treatment centres was feasible, however workforce issues and regulatory requirements made it more difficult at smaller regional and rural sites.
Publishing of trial results is improving
Reporting of oncology trials has improved significantly over a ten-year period though more than a third of trial results are still unreported.
A study in JAMA Network Open said unreported trials represent a violation of human rights.
The study of more than 12,000 interventional oncology trials registered between 2007 and 2017 found 60.7% reported on ClinicalTrials.gov or in journal articles.
“The percentage of trials that reported results within 24 months of the primary completion date increased by 34.0% (95% CI, 30.3%-37.7%) from 5.1% in or before 2007 to 39.1% in 2017,” the study said.
More recent trials and larger trials were more likely to report while terminated trials were less likely to report.
“This finding is important because terminated trials may offer potentially critical information about the lack of improved outcomes and/or adverse effects or may contradict the original assumptions of researchers and previous evidence.”
Melanoma in young people presents late
A national case series of all paediatric and adolescent malignant melanoma presenting to ANZCHOG Childhood Cancer Centres in Australia and New Zealand has demonstrated the lethality of the disease in under 18 year olds.
In the series of 37 cases seen between 1994 and 2014, staging at diagnosis were 21.6% stage I, 24.3% stage II, 10.8% stage III and 29.7% stage IV.
The median age at diagnosis was 10 years. Where descriptions of the lesions at presentation were available, most lesions were pigmented (55%).
“Breslow thickness was reported in 25 cases and nearly 30% (11 cases) had thick lesions with a measurement greater than 4mm at presentation.”
Of the 11 patients who relapsed, 90% of patients died of the disease.
“Our findings strongly suggest that patients are usually referred to tertiary oncology centres only when harbouring advanced stages of the disease, which likely also explain the relatively high death rate of 27% that was observed.”