Enhancing clinical trial capability and capacity
Increasing clinical trial disciplines, efficiencies and providing resources, offers the Victorian cancer sector opportunities to expand patient access, diversify workforce skills and implement new approaches. The VCCC continues to lead advancements in Victoria’s clinical trial landscape.
Addressing the number one unmet need
Investigator-initiated trials (IIT) are established and managed by non-pharmaceutical researchers, such as clinicians and researchers working in a healthcare setting. IITs benefit patients by asking important clinical questions that pharmaceutical or biotech industries are less likely to invest in.
The VCCC Investigator-Initiated Trials Capacity Building Program has facilitated support mechanisms for several trials, from fully-funded concepts to idea generation and protocol development. The trials supported through the program received knowledge and coaching from experienced investigators in addition to trial management, site management and biostatistical support. A toolkit of downloadable resources and process maps has been developed to guide early-to-mid career investigators, as well as clinical trial staff, through the trial process.
Building clinical trial capability
Palliative care incorporates good symptom management with a team approach to patient and carer communication. Clinical trials in palliative care are essential for establishing and creating new standards, backed by robust evidence.
The VCCC Building Trial Group Capability Program focuses palliative care leadership and activity in the cancer sector to increase workforce skills, and access to advanced palliative care approaches. The program has enabled a growth in palliative care trials, increasing workforce resources, networks, connections, knowledge and shared learnings, as well as patient outcomes.
Overcoming barriers to clinical trial access
Cancer biology is not constrained by the social definition of adulthood, 18 years and over.
Adolescents (15-17 years) can develop adult-type cancers, and young adults (18-25 years) can develop paediatric-type cancers. For these patients, there is often a disconnect between place of care, tumour- specific oncology expertise, and access to state-of- the-art treatments via clinical trials.
The VCCC Increasing Adolescent and Young Adult (AYA) Access to Clinical Trials Program successfully requested that the Australian Therapeutic Goods Administration (TGA) adopt the US Food and Drug Administration (FDA) guideline to include adolescent patients in adult oncology clinical trials. In addition, an AYA clinical trial ethics and governance guideline and a standard operating procedure for young adult access to a paediatric clinical trial, have been developed and can be freely accessed online for implementation in healthcare settings.
Improving clinical trial data
Clinician awareness of clinical trial availability is key to patient recruitment. Provision of real-time trial information with reliable, accurate and up-to-date data is required to ensure recruitment is active. In collaboration with Cancer Council Victoria, the VCCC Increasing Awareness of Clinical Trials Program is developing efficient, practical enhancement options aimed at improving the Victorian Cancer Trials Link platform.
Delivering cancer care close to home
The VCCC is focused on improving outcomes for patients with cancer no matter where they live in metropolitan, regional or rural Victoria.
Developing the regional workforce
The VCCC Teletrial Program provides a framework for clinical trial sites to partner across multiple organisations, including regional sites, increasing trial treatment opportunities for patients closer to home.
The framework, supported by a library of new resources, is currently being used by four trials across seven Victorian sites. These resources have been developed to have broad relevance and application across the Victorian setting. Successful implementation has increased the range of trial participants, in addition to advancing telehealth-based shared care models. Alfred Health has applied the framework to continue trial participation for a patient from Hobart, unable to travel to Victoria due to COVID-19 pandemic restrictions.
Clinical trial site efficiencies have improved with the application of a digital portal to 17 regional and metropolitan clinical trial units, for management of regulatory administration. The portal provides opportunities for remote trial monitoring, diversifying trial participant population and the capability to grow the regional trial load.
Further capacity building for regional clinical trial sites has been enabled through placement of clinical trial assistant and study coordinator interns. The dedicated roles support implementation of quality improvement projects to enhance regulatory and reporting procedures required for trial compliance.
Connected to expanded networks
The VCCC has signed Memorandums of Understanding with Bendigo Health and Albury Wodonga Health to establish VCCC Affiliated Partners, in an important extension of the alliance network.
The partnerships will enable the VCCC to further extend clinical trial programs into Victorian regional cancer centres, growing access to trials, building connections between regional and metropolitan health workforces, leading to better cancer outcomes for regional patients with cancer.