Increasing awareness and access to early-phase clinical trials

The VCCC Alliance project, Increasing awareness and access to early-phase clinical trials, aims to provide accessible information for consumers and clinical trial staff, including research coordinators and clinicians.

About the project

Recruiting participants for clinical trials poses a considerable challenge, particularly for early-phase clinical trials, which are unique due to their specialised nature and the timing of their offerings.

Providing adequate information to support a consumer's decision to participate is complex and can be further complicated by pre-conceived ideas of what it means to be involved in a clinical trial.

In response, the VCCC Alliance's Accelerating Novel Therapies program collaborated with our member sites Western Health, Peter MacCallum Cancer Centre, Austin Health, and St Vincent's Hospital Melbourne to conduct a quality improvement exercise and develop recommendations about how to produce materials that cater to consumer needs, including providing examples.

Recommendations

Focus groups, involving consumers and advocates, reviewed available materials and communication methods and produced the following recommendations:

Early phase clinical trial information providers

• Direct consumers to trusted resources using recommendations from reliable sources.
• Include the entire clinical trials team in the clinical trial discussions with participants. This can involve specialists, clinical trials team members. GPs were recognised as particularly trustworthy sources.
• Allocate sufficient time for discussion and processing of clinical trial information. Time should allow for discussions with GPs, specialists, trials staff, family, and friends.
• Healthcare professionals should enable the clinical trial discussion to include wider consumer concerns such as palliative care, logistics, financial costs, and discussions around hope.

Early-phase clinical trial information

• Provide clear, ‘staged’ information – the right information at the right time. This may be in a single document or in a separate document to cater to varying health literacy levels and information needs. Clarity is key because this project identified that early phase clinical trial patients were more likely to have additional considerations impacting their ability to receive education. This included receiving large volumes of information from multiple sources and specialists, at a time when they may be undergoing treatment and experiencing side effects such as ‘chemo fog’.
• Provide a range of resources allowing for differing needs – eg general clinical trial information, specific trial information and ‘decision making aids’ to facilitate discussions about clinical trials with participants. (see below for an available example, the Is a Clinical Trials Right for You? document.)
• Consider different formats, including hard copies and digital.
• Ensure cultural relevance and accessibility, including translations.

Equitable early phase clinical trial information - examples

To answer these recommendations, the VCCC Alliance Accelerating Novel Therapies team in collaboration with the Parkville Cancer Clinical Trials Unit (PCCTU), identified a resource that met the accessible and equitable criteria. The PCCTU document "Is a Clinical Trial Right for You?" was then translated into 18 languages. These cover the 10 most prevalent languages from each member site associated with the project, and the top 10 languages in Australia.

The document is available in different languages here:

• English
• Arabic
• Bosnian
• Burmese
• Chinese (Simplified)
• Chinese (Traditional)
• Croatian
• Farsi
• Filipino
• Greek
• Hakha Chin
• Hindi
• Italian
• Macedonian
• Punjabi
• Serbian
• Spanish
• Turkish
• Vietnamese

As this is a quality improvement exercise, ethics approval is not required for these documents.

View the Conference Poster presented at COSA 2023.