Who can participate in a clinical trial?
What are the different types of clinical trials?
What are the different phases of treatment clinical trials?
What happens during a clinical trial?
What are the benefits and risks of participating in a clinical trial?
What are the side effects and adverse events?
Will taking part in a clinical trial cost me money?
What should people consider before participating in a trial?
Does a participant continue to see their General Practitioner while in a trial?
Can a participant leave a clinical trial after it's begun?
Do people involved in trials get access to the results all the way through?
Is there someone, other than a doctor, to talk to about being in a clinical trial?
Clinical trial participation is voluntary and open to anyone who meets certain guidelines set out in the research protocol. These guidelines are called inclusion and exclusion criteria and are often based on factors such as age, gender, type and stage of disease, previous medical treatments and other medical conditions. Inclusion and exclusion criteria help ensure the safety of participants.
All clinical trials are carried out according to a protocol. A protocol is like an instruction manual for a clinical trial. Protocols are written by experts in their field to protect the safety of participants and to ensure the research question is being answered.
A protocol sets out who may participate in the trial, how long the trial will go for and how many visits to a clinic or hospital a participant will need to make. The protocol will also outline any tests to be carried out as part of the trial and give details of any medications to be taken as part of the research.
Treatment clinical trials are conducted in phases. A new treatment must start in a phase 1 trial and progress through the different phases before it can be made available to the public. The trials at each phase have a different purpose and help scientists answer different questions.
In Phase 1 trials, researchers test an experimental treatment for the first time in a small group of people (approximately 20) to asses its safety, to determine what is a safe dose and to identify any side effects.
In Phase 2 trials, the experimental treatment is given to a larger group of people (about 80) to see if it's effective against the illness or condition being studied and to further evaluate its safety.
In Phase 3 trials, the experimental treatment is given to an even larger group of people (hundreds, even thousands) to confirm its effectiveness, to monitor side effects and to compare it to commonly used treatments or current usual practice.
Informed consent is the process of learning about a clinical trial before deciding whether or not to participate. The research team will first give a detailed explanation of the study. If the participant's native language is not English, translation assistance can usually be provided. The research team then provides an informed consent document, which includes all of the information a potential participant should know about the clinical trial.
Those considering entering a clinical trial should read the informed consent document carefully and ask their doctor or a member of the research team to explain anything that's unclear. The participant then decides whether or not to sign the document and proceed with the trial. Informed consent is not a contract, and the participant may withdraw from the trial at any time and still receive the best available care.
Participants in a clinical trial work very closely with the research team which can include doctors, nurses, clinical research coordinators and other health care professionals.
At the beginning of a clinical trial, participants may be asked to have extra tests such as CT and bone scans to make sure they are eligible to participate. They're then guided through the trial by the research team who will monitor their progress carefully and organise any tests or investigations that are required as part of the trial. Some clinical trials involve more tests and hospital visits than the participant would normally have for their illness or condition.
Benefits: Clinical trials enable eligible participants to
Risks: There are risks to clinical trials
Side effects are any undesirable outcomes from the experimental treatment and are often expected to occur. For example, hair loss is a known side effect of some types of chemotherapy. Other side effects of cancer treatment can include fatigue, headaches, nausea and skin irritation.
Adverse events are unexpeced medical problems that arise during treatment. Side effects and adverse events are monitored by research staff throughout a clinical trial and the treatment given to participants may be altered if they experience severe side effects or adverse events.
No more so than if you did not take part in a clinical trial. Any tests, medications or procedures that are part of a clinical trial and not part of standard care will be paid for by the sponsor of the trial. It's rare that people are paid to participate in clinical trials but sometimes money is provided to cover travel expenses.
People should know as much as possible about the clinical trial before deciding to take part. Following is a list of questions a potential participant may wish to discuss with the research team.
Yes. Most clinical trials provide short-term treatments related to a specific illness or condition, but do not provide extended or complete primary health care. In addition, by having the GP health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the trial treatments.
Yes. Participation in a clinical trial is completely voluntary and participants can choose to leave a clinical trial at any time, without even providing a reason. This will not change the relationship they have with their doctor and treating clinic, who will still receive the best possible care.
Results of a clinical trial are usually not published until the trial has finished. Some results may be released while the study is ongoing but this happens rarely. It can take a number of years for a research question to be completely answered.
For example, a trial may want to measure survival without any evidence of disease in women with a certain type of breast cancer at 5 years post-diagnosis. It will take time, sometimes years, to recruit the required number of participants. They are then monitored for 5 years and following that the research team has to analyse all of the data they have collected during that time. It would not be unusual for a trial such as that to take 8 years or more to publish any results.
Once published, all participants should have access to the results. Results may also be presented at scientific meetings.
The cancer nurses at Cancer Council Victoria's Cancer Information and Support Service can help potential participants put together a list of questions for their doctors when discussing clinical trials and treatment options. Call 13 11 20 to speak to a cancer nurse.
Cancer Council Victoria's Clinical Trials Office can provide general information about clinical trials, email trials@cancervic.org.au.
http://clinicaltrials.gov/ct2/info/glossary
Glossary of clinical trial terms
http://www.medicinesaustralia.com.au/pages/page39.asp
Clinical trial information listed by Medicines Australia representing pharmaceutical industry
http://clinicaltrials.gov/
Search for a clinical trial registered at ClinicalTrials.gov
http://www.cancervoicesvic.org.au/
A forum for people touched by all types of cancer
http://www.cancer.net/ - Clinician approved cancer information supported by the American Society of Clinical Oncology
Some of this information has been adapted from the clinicaltrials.gov website
www.clinicaltrials.gov
United States, National Library of Medicine, National Institutes of Health.
