MS Clinical Trials and Research in Australia

Dr Lisa Melton, Research Development Manager presents an update on the Multiple Sclerosis Clinical Trials Network and MS research in Australia. 

Transcript of Presentation

I just wanted to talk to you a little bit about MS Research Australia and the clinical trials network that we have set up a few years ago.  MS Research Australia is the research arm of MS Australia and we have been around now for 7 years. What we aim to do is to fund and co-ordinate MS Research throughout Australia. We work with the Scientists in research groups and Universities all over Australia and we also try and keep ourselves connected to all of those and keep them connected to each other. We try and get the Scientists working together, all pushing in the same directions to get the best results for progress into finding better treatments and ways to prevent MS.

Our strategy is to invest in research itself, fund the projects that need funding, to try to increase the capacity for MS Research in Australia, which is really to fund the young researchers, the up and coming doctors and scientists that will be the researchers of the future. So we are trying to increase the numbers and the quality of science in MS research and really, as I mentioned trying to get people working together. We host workshops and we have co-ordinated The ANZGene Consortium that David Booth spoke about. We also fund a research conference that happens every other year and we stimulate new ideas for researchers to work together.

The collaborative research platforms, ANZGene being one of those are a big area that we work on and Theresa’s going to talk about The Brain Bank. But the one I really wanted to talk about today was the clinical trials network.

Just to quickly touch on, this slide really represents everything that you have heard today, in terms of what the doctors and scientists you’ve heard from today have been talking about.

Really our goals are to prevent MS from happening in the first place, that really is the best case scenario for the future. We are trying to find new ways to diagnose and treat MS. You have heard about how important it is to treat MS early. Better ways to diagnose MS and track the progress of MS is really important. The drug therapies that Dr Hodgkinson talked about are targeted at the immune response. We really need to tackle the degeneration of the neurons and the myelin that is already occurring.

The clinical trials network was set up a few years ago. To really encourage clinical research within Australia. Get more doctors and more patients involved in clinical trials and give everyone the opportunity to get access to new areas of treatment.

We have an Executive Committee of very experienced MS clinical trial neurologists, who provide the reviewing and the information for the whole network. We have a variety of ways, really it is about communication in the most part, bringing doctors and clinicians together but also feeding information to people with MS and feeding information through to the doctors as well. So that everyone is aware of the trials that are ongoing, of new information, of the results of trials and so on. So we are really trying to provide as much information as possible.

Getting involved in clinical trials. What is in it for you as a person with MS? It is one way that you can get access to new forms of treatment that you might not otherwise have access to. Especially if you have tried all the other available treatments and you are not responding or you are finding the side effects are too troublesome for you. Taking part in a clinical trial can give you the opportunity to explore new options.

It is also something you can do to help contribute to progress in MS research. In that you help progress towards new treatments and ultimately a cure. It is a great way to get involved and take part.

So clinical trials can take many and various forms. The ones that usually spring to mind are the drug trials but there are clinical trials for any medical intervention that you can think of. Be that surgery, physiotherapy and information tools as well.

They are usually run by health professionals, researchers or the pharmaceutically industry. In the main they are always approved of an ethical committee that will look at the evidence for the trial, what has come before it, what is the scientific evidence for this new intervention. Look at the risks, look at the benefits and make a collective decision as to whether it is an ethically designed or ethically based trial. It is really important to ensure, if you are taking place in a clinical trial, that all these things are in place.

Trials are designed to get the best information. Both Suzanne Hodgkinson and Jeanette Lechner-Scott talked about the importance of the way that clinical trials are designed. Choosing the patients, or not choosing the patients, but randomly assigning patients to different treatment groups. Making sure that the patients and the doctors do not know whether the patient is on the treatment drug or placebo is really, really important. So you can objectively study the side effects of the treatment and whether the treatment is effective.

The Placebo effect is a reality; it can have a huge effect particularly in more invasive types of trials such as surgery. Where the knowledge that you are having a medical intervention can have a physical impact in your body and actually make something happen in your body. It is a real effect and not purely a psychological effect. It has a physiological basis so it is really important that the drug or the intervention, whatever it might be, is compared against a placebo, which is a fake or a dummy treatment.

Recruiting enough numbers. Susan and Jeanette both referred to this. You need to be able to show that the statistical significance of the trial and these sorts of design features are all the gold standard features for International standards of how clinical trials are conducted. So it is important to be able to understand and have knowledge if you are thinking about a clinical trial about how the study is designed.

Many of them can be frustrating. Not knowing whether you might be taking a placebo. Obviously everyone wants to be the one that is on the drug. But is really important to find out for the future, for everybody that the drug is effective and that you are not taking costly or even potentially dangerous treatment. So placebos are very important.

So this says; Preclinicals, Phase One, Phase Two, Phase Three and Phase Four.
These are all the different steps of a clinical trial that you might be asked to get involved with. Apart from the Pre-clinicals that are usually done on the poor dumb animals, who can’t comment.

So that is all the work that is done before the drug gets anywhere near a patient to make sure that the concept, the idea, the biology is sound and to study the metabolism of the drug in a biological system.

Then you will have small safety studies, trying to find the right dosage. Which will then gradually escalate up to studies taking more patients and to getting the full placebo versus drug or intervention against each other.

And then you have the Phase Four which continues after the drug has become more widely available. You may be asked if you are interested in taking part in any of those particular phases.

Now drug trials, the phases of trials there refer mostly to drug trials. If you are not interested in testing new drugs, you can still contribute to progress in treatment and living with MS by taking part in other types of trials and these are usually run by researchers, academics and nurses and doctors who deal with patients with MS. To make sure that they the best knowledge to give you the right services, to give you the right treatment and to enable you to manage your symptoms in the most effective way. Based on evidence, based on real knowledge about whether these things work or not.

So the doctors you see here. Dr Sophie Hill is doing a study at the moment in Melbourne on the best way to provide people with MS information about MS, about new treatments, about drugs and so on and she is actually consulting with patients. She has got focus groups, got an online survey. She has focus groups with nurses, other service providers. To find the best way of providing information, not just information about the evidence or the data that is out there, but actually how best the patients can use this information in their own circumstances. So how best to process and synthesise that information to make real helpful decisions for you and for discussion with your doctors.

There are trials that MSRA have funded in the past into contractures and different physiotherapy techniques, strength training and so on.

We have the Longitudinal study, which is a database of people with MS surveyed regular points over the years. Many people have taken part in this and fantastically have come back and repeated the surveys year after year. So we get information on the economic impact, on employment that has already been mentioned today and on the prescription medications that people are taking. All of this stuff helps to provide the advocacy that is required to make sure the services are there for people with MS.

So in terms of clinical trials, I have really skimmed through and glanced over some of the aspects of clinical trials there. There are some really good reading materials that are out there. The MS International Federation has some really useful resources on clinical trials as does the Centre for Information and Study on Clinical Research Participation. Which is rather a long name for a Centre. But they have some really useful resources. That will help you understand the Clinical trials process and provide you with some tools that you can use as questions you can ask of your doctors and so on.

As I have talked about, we provide information and try to get as much information about there as possible. We have a website which possibly needs updating at the moment, but we try to provide as up-to-date information that we can about the trials that are out there and other aspects of clinical trials. We are really happy for you to give us any feedback that you might have on the information that we are able to provide but feel free to go and have a browse and have a look at that information. Thank you very much.