Clinical Trials
What is a Clinical Trial?
A clinical trial is a research study designed to evaluate the success of a new treatment in an attempt to prevent, stabilise or reduce the effects of a disease. Clinical trials are particularly important when treatment options are limited, as is still the case for pulmonary fibrosis, and involve the voluntary participation of individuals. Each individual’s response to the treatment administered is monitored closely in a clinical trial. This research is then collected and used to further the development of these treatments, in turn, helping those affected by the disease now and in the future.
Here is a short video from the Australian Clinical Trials Alliance (ACTA) to explain more about clinical trials.
Why should you consider participating in a clinical trial?
Clinical trials are the most effective way of evaluating the success of new treatment options for patients with severe disease like pulmonary fibrosis. The close monitoring of each individual’s response to the treatments in a controlled, clinical environment, allows researchers to gather comprehensive information about people at all different stages of the disease, whilst controlling for other differentiating factors such as age and lifestyle choices.
As pulmonary fibrosis is a less common disease it is vital that more patients with Pulmonary Fibrosis consider participation in a clinical trial. The success of clinical trials has been a major factor in the development of treatment options for people with Pulmonary Fibrosis. By participating in a clinical trial, you have the chance to help improve your quality of life and that of people who will be affected by pulmonary fibrosis in the future.
However, it is important to remember that clinical trials are investigational. There is no guarantee that participating in a trial will provide a medical benefit and in fact there may be risks involved. However, there may be other potential benefits to participation that include:
- contributing to medical research
- clinical trial-related care and monitoring
- potential access to an investigational drug.
Placebo and Its Importance
Most clinical trials include a placebo to help researchers more thoroughly determine the impacts of the experimental treatment. A placebo treatment is created to look identical to the research drug, but has no active ingredients. During a randomised clinical trial, some participants will be given the experimental treatment, while others will be provided with the placebo treatment. The participants and researchers will not know to which treatment ‘arm’ a person has been assigned. This eliminates the potential for bias. Having some participants on the placebo treatment and others on the experimental treatment helps researchers detect differences in any treatment effect, but also in side-effects, between the active and placebo.
Protecting the rights of Clinical Trial Participants
To ensure that the rights of individuals participating in clinical trials are protected, all trials are closely monitored and regulated by specialist committees such as Institutional Review Boards (IRBs) and Ethics Committees (ECs). These committees ensure that the rights and safety of participants are the utmost priority. As well as this, it is within a participant’s right to withdraw from a clinical trial at any point as it is a voluntary process.
How a Participant is selected
Each clinical trial has eligibility criteria that detail the type of people who can participate in the trial. Each group of participants will be chosen based on their shared characteristics. These characteristics or ‘inclusion criteria’ differ from trial to trial. Some eligibility criteria could include:
- Stage of the disease
- Medical history
- Age
- Lifestyle factors e.g. smoking/drinking
- Current medication
- Health status
Participant Responsibilities
When a patient is signed onto a clinical trial they have responsibilities that need to be respected. These will be clearly explained to the participant before the trial commences. These responsibilities may include:
- Disclosing any medication or lifestyle changes during the trial period
- Filling-out the necessary documents in a timely manner
- Limiting communication between participants so as not to interfere with the accuracy of the trial
- Attending each organised appointment
Patient support
Lung Foundation Australia offers a range of information, resources and support services for people living with Pulmonary Fibrosis. For more information and support, please visit our website.