Clinical Trials and Research Studies

Clinical trials are essential to establishing the effectiveness and efficacy of any new treatment or drug. Research studies, among other things, study the etiology, epidemiology and psycho-social aspects of disease. Before receiving funding and approval to continue, any proposed trial or study must undergo thorough medical and ethical review. Clinical trials are usually conducted in three, or sometimes four, phases. Participants in any phase of a clinical trial or study are free to withdraw at any time without explanation or penalty.

Phase I

These trials involve trying the proposed treatment on a small group of healthy individuals and using low doses in order to determine safety and possible side effects.

Phase II

These trials are also small but involve the patient group for whom the drug is being developed. The primary concern, aside from safety, is the most effective dosage.  

Phase III

These trials involve large numbers of people who belong to the target population to benefit from the drug. These trials are double blind; that is, neither the administrators of the trial nor the participants know what the participants are getting. Some trials involve the study drug and a placebo. In other cases, the double blind trial involves comparing the new drug to one already approved to see whether and / or how it is more effective. 

Phase IV

Once the drug is on the market, further follow-up trials may be conducted to establish its efficacy.                            

If you are interested in learning about upcoming clinical trials and research studies for alpha-1, and possibly participating in them, the best way is to become part of an Alpha-1 Canadian Research Registry.

There are currently two clinical trials underway in Canada. One in the Western Provinces and one in Central Canada.