VictorianComprehensive Cancer Centre |Annual Report 2017–18 EXPANDING THE TRIAL PORTFOLIO Building Trial Group Capability Specific expertise is critical to the success of this program. A steering committee has been appointed Only a relatively narrow field of cancer specialities and plans are in place for the recruitment of a medical have developed a depth of clinical trial expertise. oncologist and coordinator. Initial discussions are This program supports the development of clinical taking place with international collaborators to trial activity in a broader range of clinical disciplines access targeted therapies. thus expanding the number of trials and increasing patient participation. Once the N=1 trial framework is in place, this program will provide more options for patients with suitable Through development of academic leadership in genomic profiles. key disciplines; creation of networks of clinicians and healthcare professionals across VCCC Registry Trials organisations, and training and mentoring for new clinical trial investigators within the network, Registry Trials combine conventional trial this program is broadening and diversifying the methodology with registry systems to produce range of clinical trials available. The program also real-world clinical evidence. The approach integrates includes Clinical Trial Fellowships and access to the the high internal validity (elimination of bias) of clinical trials resources and workforce development randomised clinical trials with the high external opportunities in other programs within the VCCC validity (applicable to a clinical setting) associated clinical trials portfolio. with enrolling real-world patients. The initial phase of the program is focussed on Registry-based randomised controlled trials, or registry building capacity for trials in palliative care. trials, operate with broad eligibility criteria, enabling A first observational trial has been submitted trial access to a large group of participants. Data for ethics approval. collection is achieved via the registries during routine care, delivering valuable infrastructure for collecting With a view to long-term sustainability, opportunities baseline and outcome treatment data. to work with industry partners are being sought. Combining patient access with comparable New Approaches to Clinical Trials randomised treatment researchers can answer simple, pragmatic questions, such as treatment duration, N=1 trial is a novel trial design suited to precision strategies or combinations, at a far lower cost than oncology, providing an option for some patients to conventional randomised trials. access a targeted therapy. This new approach to trial design provides a framework to perform a preliminary Under this program, criteria for registry trial evaluation of response to new therapies and to assessment has been established and the first three investigate predictors of who will or won’t respond registry trials have been selected and approved, and through biomarker evaluation. are expected to begin in September 2018. This program provides an option to treat patients Outcomes will be assessed in a formal evaluation in instances where genomic pathology identifies of the registry trial concept and benefits to clinical an actionable mutation (genetic lesions that indicate practice and patient outcomes. a likely response to a targeted therapy) when a suitable clinical trial is not currently recruiting. This complements the work being done in the Precision Oncology program (refer to page 45). 52