Today is Clinical Trials Day and we would like to raise awareness of the importance of clinical trials and research in Australia, New Zealand, and around the world. We would also like to spotlight the vital role that clinicians and researchers play in conducting this life-changing research. Today we celebrate and give thanks to our MS researchers and the volunteers who participate in MS clinical trials.
On a global scale, clinical trials have allowed for COVID-19 vaccines to be developed and millions now safely administered, giving hope in the face of the pandemic.
For the MS community, clinical trials help to determine if a new drug, or other interventions such as surgery, physiotherapy, or psychological support, are safe and effective. For people with MS, participating in clinical research may provide early access to new treatments and an improved quality of life, plus the benefit of knowing they are helping others in the MS community.
What are clinical trials?
Clinical trials are usually the final steps before new medical interventions are introduced to the clinic. They are the accumulation of extensive research and work, with many bright ideas failing to even reach this step.
Clinical trials are essential to prove that the new proposed intervention is safe and effective, including comparison to what is currently used and to ensure treatments are evidence-based. In saying that, by the time an intervention gets to the trial stage a huge body of work has usually already been done to try to ensure the safety of any procedure or treatment, for example in laboratory models.
Clinical trials, particularly pharmaceutical treatments, are undertaken in carefully monitored and regulated phases. The number of people needed in each phase can vary greatly depending on the treatment and the expected effect.
There are four phases of clinical trials:
MS Research Australia Clinical Trials Network
MS Research Australia hosts a Clinical Trials Network website that lists MS specific clinical trials and research studies in Australia that the MS community can participate in. This network was established to encourage high quality clinical MS research in Australia and New Zealand and to increase awareness of clinical trials and clinical research for people with MS. Other sites listing clinical trials available in Australia include ANZCTR and ClinicalTrials.gov.
Trials in Phase 1:
- Includes a trial looking at the safety and effects of magnetic brain stimulation, to see if it has potential to regrow damaged nerves and treat progressive MS.
Trials in Phase 2:
- Includes a trial in progressive MS, infusing immune cells derived from another person to specifically target the Epstein Barr Virus (EBV), which is implicated in MS risk and disease processes.
Trials in Phase 3:
- Includes trials of a new class of medications called BTK inhibitors, for relapsing-remitting MS (evobrutinib), non-relapsing secondary progressive MS (tolebrutinib) and primary progressive MS (fenebrutinib).
Trials of AHSCT:
There are three trials underway looking at the risks and benefits of autologous haematopoietic stem cell transplantation (AHSCT) for highly active or treatment-resistant MS. AHSCT involves chemotherapy then reinfusion of a person’s own stem cells to regrow a more “tolerant” immune system.
- Include work to understand the underlying neurophysiological causes of fatigue, towards developing better therapies for this invisible but often very impactful symptom of MS.
- Other studies are trying to better understand the effects of diet on progression of MS; how people with MS feel about family planning; the experience of young unpaid carers, to better support their needs; whether music therapy in combination with other interventions can improve walking in MS (as well as work to promote access to our beautiful beaches in Australia to increase the wellbeing of people with mobility issues.
Please visit mstrials.org.au for a list of trials currently recruiting in Australia.
A new way forward: Adaptive Clinical Trials
At MS Research Australia, we appreciate that people living with MS require access and opportunity to clinical drug trials of high quality that address their current needs and place them firmly at the centre of the research. We are currently undertaking projects aimed at understanding clinical trial accessibility needs for researchers, research centres and for people living with MS, and to propose solutions to fulfill these needs. Part of this plan involves advocating for adaptive clinical trials, which are more patient centred studies allowing for modifications during a study to improve the likelihood of a trial being successful, and therefore, more beneficial, for the person living with MS.
We look forward to bringing you more information as it becomes available regarding our support for Adaptive Clinical Trials in Australia.