An Australian-first approach to cancer clinical trials – called registry-based randomised controlled trials or registry trials – will enhance the ability of clinicians to select the right treatments for patients
Working with partners across the Victorian Comprehensive Cancer Centre (VCCC) alliance and private health services, the first Australian cancer-focused registry trials will investigate and evaluate promising new cancer treatment strategies for bowel cancer and brain tumours.
Registry trials are facilitated by the comprehensive clinical data captured in clinical registries at many hospitals, including VCCC partner hospitals, enabling researchers to compare the impact of different treatment strategies on large numbers of patients in a real-world setting.
Conventional cancer clinical trials typically have strict patient eligibility criteria, limiting patient access. For less common types of cancers, this can restrict researchers’ access to enough patients to draw statistically valid conclusions.
Previous international research in cardiovascular-focused registry trials has shown that, as well as accelerating patient recruitment, registry trials cost much less than conventional cancer trials and are also much simpler to conduct.
At a glance
- Registry trials bring together data from a range of patients at multiple hospitals, enabling researchers to better evaluate the impact of different cancer therapy strategies in the real-world setting.
- Australian-first cancer randomised registry trials have been initiated within the framework of the VCCC alliance, with plans underway to extend the trials to other health services.
- Registry trials can simplify trial conduct, test different treatment strategies in a routine care patient population and increase patient recruitment while evaluating efficacy and safety.
Enhancing clinical trials
Registry-based randomised controlled trials or registry trials have many advantages over conventional randomised clinical trials, according to Professor Peter Gibbs, clinician-scientist at the Walter and Eliza Hall Institute, medical oncologist at Western Health and the VCCC Research & Education Lead – Gastro-Intestinal Cancers, and Walter and Eliza Hall Institute PhD student Siavash Foroughi. Mr Foroughi, Professor Gibbs and colleagues reviewed the promising data related to registry trials in an article recently published in Asia-Pacific Journal of Clinical Oncology.
Mr Foroughi found the potential of registry trials had recently been demonstrated in cardiovascular trials and had potential across other disease types.
“We concluded registry trials provide a timely and cost‐effective solution to answering important clinical questions for cancer patients, many of which are not being addressed by conventional trials. Outcomes could assist clinical decision-making for cancer treatments while bridging the gap between randomised clinical trials and observational studies, including phase IV clinical trials,” Mr Foroughi said.
New clinical trials starting
Registry trials have recently been initiated for two cancer treatment strategies:
- ALT-TRACC – investigating alternating two cycles of doublet chemotherapy versus standard continuous doublet chemotherapy as a new treatment strategy for newly diagnosed metastatic colorectal cancer
- EX-TEM – examining the effectiveness of six months versus 12 months of post-radiation chemotherapy for glioblastoma, an aggressive form of brain cancer
These trials will soon open at multiple Victorian health services, with support provided through the VCCC alliance. Clinicians will have access to the data in existing cancer registries to evaluate patients’ treatments and outcomes. Several more trials are in development, aimed at improving the care of patients with other tumour types, including pancreas and prostate cancer. Registry trials will also, in the near future, enable other underserviced areas of research, such as optimising palliative care and surgical interventions.
Professor Gibbs said the registry trials were an exciting new development for understanding how treatment strategies impact patients.
“Despite statistical advances, comparative observational registry studies have not been widely accepted by the cancer research community as sufficient to change standards of care,” he said.
“We believe there is enormous potential for registry trials to enhance and accelerate cancer research and to bridge the gap between conventional clinical trials and purely observational studies.
“These trials will enable us to evaluate multiple treatment strategies and give oncologists more insight into the best approaches for improving health outcomes for individual patients.
“As for all clinical trials, informed consent, high quality data collection, careful data analysis, data security and patient privacy will be of paramount importance,” Professor Gibbs said.
In summary: key strengths of the registry-based approach
- High external validity through inclusion of real‐world patients and smaller centres
- Can answer simple, pragmatic questions that are otherwise unlikely to ever be explored
- Rapid patient recruitment due to broad eligibility criteria
- Data collection is integrated into routine care
- Substantially lower costs than conventional randomised clinical trials.
Professor Peter Gibbs, image credit: Walter and Eliza Hall Institute
Siavash Foroughi, image credit: Walter and Eliza Hall Institute
Article source: Victorian Comprehensive Cancer Centre