Frequently Asked Questions
What are clinical trials?
Clinical trials are research studies that involve people. They test whether new treatments work and how safe these treatments are.
Who can join a clinical trial?
Clinical trial participants are carefully chosen to best answer the research question of each clinical trial. To do this, every clinical trial has a unique set of inclusion and exclusion criteria that determine a person’s eligibility for each trial.
A person must meet all inclusion criteria and no exclusion criteria to be eligible to enrol in the clinical trial.
How do you find a clinical trial?
The best way to find a clinical trial is to search a clinical trials database. These include:
- Australian Clinical Trials
- Australian New Zealand Clinical Trials Registry
- European Union Clinical Trials Register
- International Clinical Trials Registry Platform
Can I get notifications about new clinical trials?
Who runs a clinical trial?
Clinical trials may be run by pharmaceutical or biotechnology companies, by a team of doctors and researchers at hospitals or healthcare centres, or both.
The Study Sponsor is the person or organisation responsible for running the trial. It may be an individual, a company, government agency, university, hospital or other organisation.
The Principal Investigator or Study Director is the doctor or researcher in charge of the trial.
A study site is a place where the study is conducted. It may be a hospital, a doctor’s clinic, or a healthcare centre. Most clinical trials have many study sites.
How do you enrol in a clinical trial?
The first step is to contact the study organisers. Contact details are often given at the bottom of clinical trial listings on sites like Australian Clinical Trials or ClinicalTrials.gov. If there are no details, contact:
- The organisation sponsoring the trial (the Study Sponsor)
- The person named as Study Director or Principal Investigator
- Your regular treating team.
What is informed consent?
Before taking part in a clinical trial, the participant or their parent or guardian is asked to sign an informed consent form.
The informed consent form contains important information about the trial, such as:
- The purpose of the trial
- What is involved
- How long it will run for.
When a participant or their parent or guardian signs the form, they are confirming they have understood all information in the form.
Are participants paid to be in a clinical trial?
It depends on which country the trial is being run in, and what sort of trial it is. In Australia, participants are not usually paid to be part of a clinical trial.
The trial sponsor sometimes pays for expenses such as travel costs.
Do participants have to pay to be in a clinical trial?
No. A study investigator should never ask for payment for the trial treatment.
What safeguards protect people in clinical trials?
Many things are done to keep clinical trial participants safe. These include:
- Careful design of the study protocol, overseen by an independent ethics committee
- Government regulations stating how clinical trials must be conducted and overseen
- Ongoing monitoring of the participants and the results of the study.
What happens during a clinical trial?
All clinical trials follow a protocol. This is a detailed plan that tells the clinical trial investigators how the study will be run. The protocol includes:
- What will happen and when
- What will be assessed
- How the findings will be analysed
- How any side effects will be managed.
Generally, the stages of a clinical trial are:
- Screening to check participants are eligible.
- Participants give informed consent.
- Baseline assessments (pre-study tests) done.
- Treatment starts.
- Regular visits to the clinical trial site, including assessments to see if the treatment is safe and effective. Some participants receive treatment at the study site or another healthcare centre. Other participants will receive the treatment at home.
- End of treatment, including end-of-study assessments.
- Follow-up period. This may be a short time (e.g. weeks) or longer (e.g. years). It may involve regular visits or phone calls with the clinical study team.
Can you continue taking the trial treatment once the clinical trial is over?
Sometimes participants who are benefiting from a treatment can continue receiving the treatment after the study finishes. It depends on many things, including the clinical trial phase, the sponsor, whether the treatment was effective, and the country the trial is being conducted in.
This is a good question to ask the study sponsor when considering joining a trial.
What are the chances I will get a placebo?
This depends on the individual clinical trial. Many trials do not include a placebo. Other trials treat only a small number of participants with a placebo. In some trials, those on a placebo are given the option to cross over to the active treatment if it becomes clear the active treatment is effective and safe.
Do treatments in clinical trials always work?
Data from the United States suggests that around 14% of treatments tested in clinical trials end up being approved. This means that most treatments do not work, do not work well enough or are not safe enough to be fully tested and approved.
Sometimes a treatment works well in some, but not all, people. Although a small number of people could benefit from the treatment, development of the treatment may be stopped, and the treatment may never enter routine use.
Can I quit a clinical trial?
Yes – at any time and for any reason.