Frequently Asked Questions
What is a clinical trial?
The World Health Organization (WHO) defines a clinical trial as ‘any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes’.
Clinical trials to develop new medications are conducted in phases:
Phase 1 – To evaluate safety
Phase 2 – To determine efficacy
Phase 3 – To compare with current standard treatments
Phase 4 – To monitor for long term adverse effects
Why should I take part in a clinical trial?
The participation of patients is a key part of the clinical research process, and important for researching potential future treatments for arthritic and musculoskeletal conditions that impact so many in their daily lives. By participating in a clinical trial, you will be taking a more active role in your own health care and those of future generations. Participating in a clinical trial also allows patients to gain access to novel drugs typically not available in the market yet.
Am I eligible to participate in a clinical trial?
All clinical trials have certain guidelines for participating, called the inclusion and exclusion criteria. These criteria may be based on age, gender, type and stage of a disease or condition, current medications, previous treatment history, and other medical conditions. Our study coordinators will go through this with you to assess your eligibility.
How do I participate in a clinical trial?
To participate in a clinical research study, you must be willing to follow a study plan and attend routinely scheduled study visits. An informed consent document will be given to you that includes information about the clinical study, as well as potential benefits and possible risks associated with the research study. You should carefully consider and talk with your doctors and family about both the potential benefits and risk of participation before enrolling in a clinical study.
Once you agree to participate, you will have a visit to the clinic to assess your eligibility to participate in the study and sign the consent form. During the visit, tests performed for a study may include blood and urine sample collection for laboratory analysis, physical assessment, medications reviews, ECG, X-ray and MRI.
Where do I go for my clinical trial visit?
Your visits will be conducted at our clinic in Victoria Park WA. Some visits may require an ECG, X-ray or MRI test to be performed. These will be done at off-site locations, Western Cardiology and SKG Radiology.
What happens during a clinical trial?
You will receive study-related medical care throughout the study. You will also be monitored by the research team to assess your health and well-being. During the study, you can report any side effects that you have experienced at any time to our research team.
Treatment in a clinical research study is not too different from any other treatment. If you have problems with the treatment, you can stop it at any time or your study doctor may also stop your treatment. If you do well with the treatment you may have the opportunity of continuing on that treatment after the study finishes. That will depend on the individual clinical trial.
Will it cost me anything to participate?
All study medication and study-related medical care will be provided at no cost to you. For most studies, you do not get paid for taking part, but travel cost to the study clinic will be reasonably reimbursed.
Useful Links
Arthritis Foundation: www.arthritis.org
Arthritis Foundation of WA: www.arthritiswa.org.au
Arthritis Australia: www.arthritisaustralia.com.au
TGA: www.tga.gov.au
Bellberry Limited: www.bellberry.com.au
Clinical Trials Registry: www.clinicaltrials.gov
Australian Clinical Trials: www.australianclinicaltrials.gov.au