Led by Professor Peter Gibbs and supported by Doctors Vanessa Wong, Lucy Gately, Associate Professor Ben Tran and Dr Steven David and project management team of Michael Harold, Catherine Morton, Megan Dumas, Roslynn Murphy, Siobhan Gallus, Kristina Zlatic and Sophie O’Haire.
Registry Clinical Trials combines conventional trial methodology with registry systems to produce real-world clinical evidence.
Registry based trials integrate the high internal validity (elimination of bias) of randomised clinical trials with the high external validity (applicable to a clinical setting) associated with enrolling real-world patients through a registry. These studies are addressing simple but important questions in the routine of common cancers, exploring issues not addressed in conventional clinical trials such as the optimal treatment sequence, combination or duration of available therapies.
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 enabled by the comprehensive clinical data captured in clinical registries at many hospitals, including all 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, high external validity through inclusion of real‐world patients and smaller centres. They can answer simple, pragmatic questions that are otherwise unlikely to ever be explored. There is rapid patient recruitment due to broad eligibility criteria.
Data collection is integrated into routine care and they substantially lower costs than conventional randomised clinical trials.
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
REAL Pro – Registry-based study of Enzalutamide vs Abiraterone assessing cognitive function in elderly patients with metastatic castration-resistant prostate cancer.
AVATAR – Stereotactic Radiotherapy for Oligoprogressive ER-positive Breast Cancer
Email: registrytrials@mh.org.au
http://www.anzctr.org.au/New trials are currently under development in brain, lung and colorectal cancer.
Reference and further reading
A comparison of conventional clinical trials and registry-based randomised controlled trials in multidisciplinary cancer care:
Foroughi S, Wong HL, Gately L, Lee M, Simons K, Tie J, Burgess AW, Gibbs P. Re-inventing the randomized controlled trial in medical oncology: The registry-based trial. Asia Pac J Clin Oncol. 2018 Jun 26. doi: 10.1111/ajco.12992.
Defining key design elements of registry-based randomised controlled trials: a scoping review
Karanatsios, B., Prang, KH., Verbunt, E, Yeung JM, Kelaher M & Gibbs P. Defining key design elements of registry-based randomised controlled trials: a scoping review. Trials 21, 552 (2020).
https://doi.org/10.1186/s13063-020-04459-z