while the current results of the study on ub-312 do show promise, it’s not likely to be quick to pharmacy shelves as clinical trials take time to ensure that the process from invention to patient use is done correctly. after all, the first phase of a clinical trial is just one of four in the u.s. the second and third phases bring the therapy to larger groups of participants – 100 to 300 and then 1000 to 3000 people – while the fourth phase would include approval from the food and drug administration (fda) and availability to the public.
once that is complete, an entirely new process would begin in canada to validate the results of the clinical trial and get approval from health canada.
“first and foremost, it’s important to look at safety and from there, it just opens up the gates to see what comes next in terms of bringing in more patients to try it and how it compares against standard therapy,” said asis.
as with anything good, it takes time for drugs, especially disease-modifying therapies, to be approved for patient use. so, people with parkinson’s may be able to hold onto some hope for the future, but it will likely take years before it’s available.
“sometimes, that could take five to 10 years. again, depending on how easy it is to recruit the participants,” said asis. “so, if this is a multinational study with lots of clinics involved—and that’s something we’re (parkinson canada) looking to do is provide more support for infrastructure for trials in canada in particular.”