Increasing the impact of clinical trials innovations
The Australian clinical trials sector is growing rapidly, particularly in Victoria – and with that growth comes a greater need for skilled professionals to move into key roles. The VCCC Alliance has continued to play a major role in expanding clinical trial capability and capacity across metropolitan and regional Victoria.
Investigator-initiated trials toolkit highlights resource appetite
Investigator-initiated trials (IITs) are established and managed by non-pharmaceutical researchers, such as clinicians and researchers working in a health institution. Most IITs are designed to support the development of new clinical practice guidelines or compare the effectiveness of existing treatments.
In early 2020, the VCCC Alliance partnered with the Melbourne Academic Centre for Health (MACH), with assistance from the Melbourne Children's Trials Centre, to develop a suite of resources to support researchers conducting investigator-initiated trials.
The IIT toolkit provides the Victorian clinical trials sector with a one-stop-shop, from research question to protocol, conducting the trial, analysing, and sharing the results. It offers clear guidance for the trial team on roles and responsibilities and provides resources to enable adherence to regulatory requirements and best practice.
By the numbers, the VCCC Alliance IIT Toolkit has been a resounding success. It attracts nearly 20 per cent of all our monthly website visits, including international traction in southern Asia, western Europe, the UK and North America. The toolkit has also seen a steady growth in traffic since launching in May 2020 and had 15,523 users in FY 20/21.
Unleashing potential via the SKILLED Internship Program
The SKILLED Internship Program reached new heights in 20/21, with the largest ever representation of post-doctorate level interns (seven) and regionally placed interns (11) among the cohort of 21 Study Coordinator and Clinical Trial Assistant interns.
Jointly funded by the Victorian Department of Jobs, Precincts and Regions and MTPConnect with regional support from Bristol Myers Squibb, the program’s benefits for Victoria’s cancer sector are two-fold: it offers talented scientists and cancer researchers a pathway into the highly competitive clinical trials field, and crucially builds capacity in regional hospitals and cancer centres to deliver best-practice clinical trials.
L-R: Shepparton-based SKILLED interns Gowtam Chalasani and Laura Hewson.
The program welcomed another tertiary partner in Monash University and continued to deliver tangible career progression outcomes. Sixty per cent of regionally placed 2020 interns gained employment at regional clinical trial units upon completion of their internship, while there was a high sector retention rate across all 2020 interns; 60 per cent were employed within clinical trial units, and 94 per cent were employed within the sector. One hundred per cent of the 2020 cohort said they were either satisfied or very satisfied with the program.
Revolutionising cancer clinical trial delivery through teletrials
Cancer clinical trials are experiencing a delivery revolution - adopting the teletrial model to implement trials across multiple sites. Teletrials provide an opportunity to widen patient recruitment, increasing patient population diversity and broadening options to investigate rare cancers. Generally, they enable clinical trials to be opened at a primary clinical trial site in addition to singular or multiple satellite sites, including metropolitan and regional locations.
The VCCC Alliance Teletrial Program has developed functional teletrial standard operating procedures (SOPs) and associated tools that can be directly applied to any clinical trial unit in Victoria and online training to support implementation.
Literature developed through the program sets out why teletrials are such an important element of efforts to reduce the gap in access to research between patients with cancer in regional and rural areas and those in metropolitan areas, and how the VCCC Alliance's Teletrials program has overcome some of the long-standing barriers to clinical trial participation.
As of April 2021, five teletrials have been implemented and several others are in the start-up phase. The first trial, conducted between Peter MacCallum Cancer Centre and two Regional Trials Network Victoria sites, has expanded to include two more sites and one subregional site. This trial to date has recruited 142 regional patients with recruitment almost completed.
"Teletrials do more than just meet trial metrics. They develop synchronous partnering between regional and metropolitan centres, allowing regional equity of access to cutting edge diagnostics and therapeutics while maintaining patients’ care delivery closer to home, thereby avoiding disruption to family, work and social interactions." – Associate Professor Ian Collins