New approaches to cancer clinical trials aim to support rapid, cost-effective studies that effectively answer clinical questions to improve patient care.
The Registry Trials Program combines conventional trial methodology with registry systems to produce real-world clinical evidence. Registry 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.
Patient accessible trials, producing cost-efficient, rapid outcomes
Randomised-controlled trials (RCTs) are a clinical trial method that provides high-level scientific evidence and is the gold standard for comparing care approaches or treatment options. RCTs facilitate rigorous evidence to support clinician decision-making. However, RCTs commonly have narrow eligibility criteria, limiting patient recruitment and external validity, as well as substantial per patient costs.
In contrast, registry-based randomised controlled trials, or registry trials, operate with broad eligibility criteria, enabling trial access to a large group of participants who represent real-world patients. Data collection is achieved via the registries during routine care practices, delivering valuable infrastructure for collecting baseline and outcome treatment data.
Combining patient access with comparable randomised treatment researchers can answer simple, pragmatic questions, such as treatment duration, strategies or combinations, at a far lower cost than conventional randomised trials.
Proof-of-concept evaluation in an oncology setting
The registry trials approach has demonstrated excellent results in cardiovascular trials, generating high impact publications that have changed standard of care treatments. The VCCC Alliance Registry Trials Program aims to, for the first time, assess this approach in an oncology setting.
Registry trials, in this program, are conducted on specific tumour streams including both common and rare cancer types. Data is collected in routine care processes from a range of health services, enabling recruitment of a large patient group. In-depth methodology and design analysis is undertaken to provide a critical evaluation of the registry trials approach and to identify success factors.
Cost-effective method; increasing investigator experience
Hypothetically, the registry trials approach is a suitable, cost-effective way to pursue clinical oncology questions, while maintaining trial rigour.
Registry trials can be conducted within usual care and are a means of introducing early career clinicians to initiating and leading clinical trials; increasing investigator experience.
VCCC Alliance partners are a critical mass of proven clinical trial facilities and infrastructure. Partner clinical sites, as well as other health services, provide resources to promote trials, support recruitment and deliver data management and analysis.
A research fellow from the Evaluation and Implementation Science Unit, Centre for Health Policy, University of Melbourne is conducting the evaluation. Meticulous analysis and evaluation of oncology registry trials will provide beneficial insights for local and international health services as well has community health outcomes.
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.
Registry trials, structure and implementation
Professor Peter Gibbs, Clinical Program Lead
Dr Vanessa Wong, Clinical Research Fellow
For further information about the VCCC Alliance Registry Trials program, contact Duncan Colyer, Program Manager: Clinical Trials Innovation (firstname.lastname@example.org).