Changes to clinical trials data collection in Victoria

With support from the Victorian Government through the Victorian Cancer Agency, Cancer Trials Australia (CTA) will assume responsibility for the collection of cancer clinical trial activity and recruitment data that has historically been reported to Cancer Council Victoria under the Cancer Trials Management Scheme.

This change will come into effect from 1 January 2023, meaning Cancer Trials Australia will  be responsible for collecting cancer clinical trial activity and recruitment data from the 1 January to 31 December 2022 and going forward.

You will receive direct communication from Cancer Trials Australia with further information about the data collection process in early 2023.

Part of this communication will include a data transfer agreement that will outline the details, including timing and mechanism of collection.

Cancer Trials Australia has recently co-developed and implemented Clinibase (a customised software solution) with Melbourne-based software solutions company, Cardiobase, which is already in use at 12 Victorian clinical trial units.

Clinibase will be used as the repository for Victorian cancer clinical trial activity and recruitment data, regardless of the site’s membership with CTA.

Clinibase will be offered as a data input interface to all participating organisations across Victoria, under a sub-license agreement with no fee for at least the first 4 years, to facilitate recording studies, including use of the reporting tools available. The reporting tools will also assist sites in meeting their obligations under the National Clinical Trial Governance framework. 

Clinical trial units who do not wish to use Clinibase will be provided with a Microsoft Excel template for data reporting, similar to previous years, which will be imported into Clinibase for storage and analysis.

Cancer Trials Australia has secured project staff to assist sites in setting up their existing data within this system, as well as creating new study records for all participating sites as required and maintaining a help desk in Victorian business hours.

Current cancer clinical trial data systems do not capture data on Aboriginal and culturally diverse Victorians taking part in clinical trials, or on clinical trials that include non-treatment related interventions. This limits patient and clinician awareness about the types of trials that are available, as well as options to participate.

The need to improve clinical trial data collection and reporting is recognised in the Victorian cancer plan 2020-2024 as an important activity to improve access for people affected by cancer in Victoria. These activities are especially important as the clinical trial sector continues to grow, and new reporting requirements, including through the National Clinical Trials Governance Framework, are established.

Cancer Trials Australia has supported the deployment and management of Information Systems at Victorian hospitals for almost a decade. Following the development and implementation of Clinibase, it is anticipated the transition of data collection to Cancer Trials Australia will:

• Allow more timely and robust data collection
• Reduce administrative burden on clinical trial sites
• Enhance internal reporting capabilities
• Assist sites with reporting under the National Clinical Trials Governance Framework
• Build on data collected by Cancer Council Victoria to include a broader set of trials and participant demographics
• Facilitate the collection of data relating to teletrial participants
• Support continued improvements to the data collection process and more granular data analysis

Data reported to Cancer Council Victoria in years 2020, 2021 and 2022, for activity that occurred between 1 January 2019 to 31 December 2021, will be securely shared with Cancer Trials Australia under existing data collection agreements with sites. Cancer Trials Australia and Cancer Council Victoria will enter into a Data Transfer Agreement to enable this to occur. Data reported for activity before 1 January 2019 will be securely stored and can be requested from Cancer Council Victoria, until further notice. Requests for data stored by Cancer Council Victoria will be fulfilled in accordance with the ‘How to access Cancer Trials Management Scheme (CTMS) data’ guide.

Cancer Council Victoria will focus our resources on enhancing the Victorian Cancer Trials Link and will continue to work with clinical trial units to ensure timely cancer clinical trials information is available to health professionals and Victorians affected by cancer. Thanks to the support of the Victorian Government through the Victorian Cancer Agency, over the next two years we're investing in and delivering an enhanced website with a better user experience, search functionality, and including new information and education resources to help Victorians understand and access cancer clinical trials.

If you would like to update or add a clinical trial to the Victorian Cancer Trials Link, please send an email to Trialslink@cancervic.org.au with the following information about the trial:

• Scientific title
• Registration number(s) – from clinicaltrials.gov, ANZCTR or other World Health Organization primary registry.  
• Date of trial open or close
• Contact details for the trial (generic addresses preferred)

By keeping the information on this platform up to date, you will be helping people affected by cancer and health professionals find clinical trials that are open in Victoria.

Requests for data reported for years 2019 to 2022 onwards will be managed by Cancer Trials Australia.

Requests for data reported before this time will be managed by Cancer Council Victoria on an individual basis and in accordance with the guidelines set out in the ‘How to access Cancer Trials Management Scheme (CTMS) data quick guide’.

For further information about this change, contact:

Kurt Lackovic via kurt.lackovic@ctaust.org

For further information or to update the Victorian Cancer Trials Link, contact: Trialslink@cancervic.org.au