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07 Mar 2023

Q&A with Dr Kortnye Smith: What is the Clinical Trialist Development Hub?

  • Peter MacCallum Cancer Centre
  • VCCC Alliance

What is the Clinical Trialist Development Hub?

The Clinical Trialist Development Hub is a VCCC Alliance initiative that aims to help emerging clinical trialists really overcome some of the hurdles to getting a novel clinical trial off the ground. It provides an avenue to pitch early ideas, refine these at peer-support workshops, interact with experienced mentors, access biostatistics and consumer input, and support protocol writing. All of these things can be very challenging to navigate for those embarking on their early experiences of establishing a clinical trial.

Why are we doing it?

Ultimately, we’re doing this for patients. Under our Accelerating Novel Therapies program at the VCCC Alliance, we’ve got a target to increase, by 16 per cent, the number of patients who can access novel therapies. To do this, we need to develop the next generation of clinical trialists. This will lead to more novel therapy trials and research, and more opportunities for patients to take part in them.

How can emerging clinical trialists apply to the hub?

There’s an Expression of Interest form to fill out and submit to apply to the hub. We understand filling out forms is time consuming and sometimes confusing – welcome to clinical trials! – so if you get stuck, you can contact us for advice and help. We’re asking researchers to produce a two-page synopsis of their concept and ideas for further investigation. The next step is to meet with an expert panel who will assess all Expression of Interests proposals against these criteria:

  • Innovation and Translation
  • Clinical significance and benefit to patient
  • Study design and feasibility
  • Patient cohort including exclusions and inclusions

What is the hub looking for from applicants?

The hub is looking to support ideas and concepts aiming to improve patient access to novel therapies across Victoria, so it's important your proposal addresses a significant clinical need in cancer therapy. The hub will also look at whether:

  • The hub’s support will provide patients access to novel therapies that have not been tested for this indication before
  • The research team includes members from one or more VCCC Alliance organisations or regional members
  • The project is feasible within the available support provided.

What happens next for successful applicants?

Successful applicants will have the opportunity to further develop their protocol with support from the hub, which will include access to specialist services to support trial design including biostatistics and protocol writing, access to mentors and peer support for clinical trial establishment, and access to clinical trial project coordination.

What about those who are unsuccessful?

For those who need a little bit more help, we’re going to provide suggestions and feedback for how they could improve next time. We don’t want to leave anyone in the dark!

Where can interested applicants find out more?

Please refer to our Expressions of Interest page for more information on how to apply and who to contact for help with the application process. You can also watch our MLL from August 29, 2022 for a whole lot of different perspectives. Listen from the 35-minute mark for more detail from me!  If you have any additional questions left, you can contact me directly at [email protected]

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