Lot of interest being expressed
With the progress being made in the Australian research on HSP and potential drugs to cure it, we are foreshadowing the possibility of human clinical trials perhaps as early as 2016.
As a result, there is considerable interest being expressed by HSPers, and not just in Australia, in volunteering for clinical trials.
As part of the Foundation mission is “facilitating research towards a cure”, we are currently exploring how we can be most helpful and effective in matching HSP volunteers for clinical trials with the requirements of the researchers.
There is a lot to be worked on in ensuring the multiple and complex considerations are factored in to coming up with the best answer. For example, the number of participants required for phase III of a clinical trial is somewhere between several hundred and several thousand… and it depends on how much variability there is in the effects of the drugs.
It may well be that there are not enough qualified participants in Australia for this. Perhaps a multi-site clinical trial will be needed, including other countries. Any patient registry that gets developed will need to allow for such eventualities when it is designed, apart from issues such as compatibility with other databases, data ownership and access, ethics and of course, funding.
Rest assured that we are using the considerable lead time to work on this now. We will keep everyone updated as we always do. When the time comes, everyone will be informed and have equal opportunity in volunteering and signing up for participation in clinical trials. Not everyone will be medically suitable, so signing up is just the 1st step and does not mean you will be participating in the trials.
It is great that there is such a level of interest. The best thing that anyone can do now is to provide funding support for the 2 new projects that will hopefully lead to approval for a clinical trial. If it is to be, it’s up to us!