Learn about clinical trials
There are major clinical trials involving people with Huntington’s disease taking place in Australia and across the world. Here is some background information about what clinical trials are and what they set out to achieve.
|What are clinical trials and why do we need them?
Clinical trials are carefully planned experiments that seek to determine whether new treatments, tests or other medical interventions are safe and effective when used to diagnose or treat people.
Trials provide an opportunity to see how people respond to a medical intervention, whether it does what is intended and whether it is safe and has no harmful side effects. Every effort is made to ensure that no harm is done to participants during trials.
Clinical trial interventions include:
Researchers conducting clinical trials, who may be either from governments, pharmaceutical or bio-chemical companies, hospitals or universities will recruit clinical teams made up of doctors, nurses and other health care professionals to be involved.
Clinical trials in Australia are regulated by laws and codes of conduct. Approval from regulatory authorities is required before a clinical trial can begin.
Who can take part?
Trials can involve all parts of the population with all types and stages of a condition.
For each trial researchers will specify inclusion and exclusion criteria. Inclusion criteria are characteristics that each person must have if they are to be included while exclusion criteria are characteristics that disqualify people from participation.
For example, in drug trials involving people with Huntington’s disease, only those who are in the early symptomatic phase are eligible.
People who volunteer for a trial will often go through a pre-screening process to check their eligibility. Further screening tests such as a clinical assessment, physical examination or blood test will then be done on those found suitable to participate.
Each person whose screening tests meets the inclusion criteria will then be provided with participant information and consent forms which outline the objectives of the research, what is expected of them and any risks involved.
How does a trial work?
Participants are often divided into two groups. One group will receive the drug or other intervention over a set period of time. The second group will be the control and will receive a placebo (a substance with no medication) or an established intervention already in place.
In a single blind clinical trial, the participants do not know whether they are receiving the drug or intervention, or whether they are in the control group but the clinical team and researchers do.
In a double blind trial, the researchers, the clinical team and the participants do not know who is receiving the drug or intervention and who is in the control group. Blinding helps to reduce the effects of bias when comparing the outcomes of the interventions.
The aim of the trial will be to compare what happens in each group and to see whether there is enough difference to prove that it has not occurred by chance.
Anybody participating in a clinical trial will be closely monitored throughout and can withdraw at any stage. The names and personal information of trial participants are confidential and cannot be disclosed.
There is usually no cost to participate in a trial with the trial sponsor covering all testing and accommodation costs.