WHAT ARE CLINICAL TRIALS AND WHY ARE THEY SO IMPORTANT

November 8, 2017

A clinical trial is where a new drug, test, device or other treatment is tested on people in real life. Whilst many new treatments will work well in the test tube, or in animal models, they often often don't work as expected or even at all in humans. There can also often be unexpected side effects or safety issues that are not apparent before the drug is trialed.

 

In medicine there is a thing called the placebo effect, this is an effect triggered by the person's belief in the benefit of the treatment and their expectation of feeling better. You may be surprised to learn that around one third of people who take placebos (any treatment that is inert, such as a sugar pill) will experience an end to their symptoms. It is important that we understand the real effect of any new treatment compared to current treatments or a placebo treatment.

 

There are several types of clinical trials the 'gold standard' is a Randomized Control Trial (RCT) where people participating in the trial are randomly selected to either receive the new treatment (treatment group) or to receive a placebo or current standard treatment (control group). It is even better when both the person and the trial investigator do not know who is receiving the treatment and who is not.

 

There are also several phases of clinical trials that are investigating different things and have different numbers of people involved.

 

A Phase I trial is done to determine the safety of a particular treatment and is generally done with very small numbers (20-60 participants).

 

A Phase II trial is done in a larger group of people and also looks at safety and side effects but is also looking at the efficacy (how well it works) in a larger number of people (often several hundred participants). Depending on the treatment sometime Phase I and II trails can be combined.

 

If you get through Phases I and II the final step before a treatment is considered for release is a Phase III trial. Phase III trials are done with larger numbers, often in the thousands, and look at the efficacy and safety of the treatment and often compare the new treatment to a current standard treatment or no treatment at all.

 

Are we doing clinical trials in Australia? If you have a look at the www.australianclinicaltrials.gov.au website you will see that we are doing quite a few clinical trials in Parkinson's. We know that further trials will be commenced in the near future including some trials of drugs that may alter the progress of Parkinson's (slow, stop or reverse the condition) - keep watching our FB page for news.

 

Running clinical trials is very expensive (Phase III trials can cost upwards of $25m to run) and you need to have adequate numbers of both clinicians, researchers and patients available to run the trial. Parkinson's Australia has been calling on the federal Government to invest more money to support new research projects and treatment trials. We would like the Government to invest at least $20m per year in Parkinson's research which is around $10m more than they invested in 2015 and $15m more than the last 12 months. To see more information on what we are advocating for in research go to www.parkinsons.org.au/publications

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