Adaptive clinical trials platform

Adaptive Clinical Trials Platform

  • The Adaptive Clinical Trials platform was launched by MS Australia early in 2021.
  • This platform aims to make adaptive clinical trials available for people with MS, and in particular, people with progressive MS.
  • Adaptive clinical trials have several superior features to traditional clinical trials, making them faster and more flexible for participants and less expensive for sponsors.
  • The first stage of this platform involved an in-depth landscape analysis of adaptive clinical trials in MS in Australia.
  • This landscape analysis sought the opinions of key stakeholders in MS clinical trials in Australia. This included pharmaceutical companies with a clinical focus and product in MS, neurologists/trialists/nurses involved in MS research, research managers and study coordinators performing MS clinical trials and people living with different types of MS.
  • The landscape analysis identified five key areas of unmet need:
    • Clinical trial preparation for staff (including submissions, preparing budgets, how to set up a centre, mentorship, and support)
    • Communication issues with study sponsors and between study sites for staff
    • Support needs for clinical trial staff including continuing education
    • Addressing barriers to clinical trial participation for people with MS (rural and remote, age, disability, social, cultural issues, onerous study procedures, previous poor trial experiences)
    • Research literacy and understanding of research procedures for people with MS

Aims of the Platform

The platform has two aims:

  • Aim 1: Develop educational modules for clinical trials staff and people with MS to improve the knowledge base for adaptive clinical trials for MS in Australia.
  • Aim 2: Develop and design an adaptive clinical trial for progressive MS to be undertaken in Australia.

Aim 1 – Adaptive Clinical Trial Educational Series

  • A series of webinars for those new to clinical trial and adaptive clinical trial management addressing gaps in knowledge aimed at improving adaptive clinical trial knowledge for research managers, study coordinators, MS Nurses and neurologists/other trialists.
  • A series of webinars for people with MS about clinical trial participation addressing concerns regarding research, ways to remove barriers to participation, increasing research knowledge, understanding research results and discussions about research and clinical trial expectations.
  • Break-out sessions at major Australian conferences (such as MS Nurses Australasia and MS Australia conferences) for clinical trial staff especially targeted to clinical trial development and continuing education of adaptive clinical trials.
  • Community or web-based sessions where people living with MS can speak to MS researchers and clinical trials staff and ask questions about the processes and what to expect.

Aim 2 – An Adaptive Clinical Trial for Progressive MS

  • An international effort for an adaptive clinical trial is already underway, commencing initially in the UK.
  • This particular adaptive clinical trial will test repurposed medications (already approved in other conditions) which show some promise in neuroprotection and remyelination, to evaluate if they are able slow progression of disability in participants with progressive MS.
  • Logistics and funding are currently being sought to possibly bring this adaptive clinical trial in Australia.
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Adaptive Clinical Trials Platform