What to expect
What is a Clinical Trial?
A clinical trial is a type of research that tests new, or existing, medical treatments to determine if they are of any benefit. Every medication that is on the market today has gone through a clinical trial.
What to expect when participating in a Clinical Trial
- A thorough screening process to determine eligibility
- Multiple visits to monitor your health & safety
- Blood tests and other pathology specimen collections
- Procedures to monitor your progress, such as: ECGs, x-rays, physical examinations, joint counts and skin assessments (study dependent)
- Surveys to be completed to tell us how you are feeling
- Professional and caring staff to support you throughout your trial duration
- Positive experiences
- Personal satisfaction for contributing to a potential medical advancement
Your safety is paramount
- There are several bodies involved in regulating clinical trials, including the FDA, TGA and Human Research Ethics Committees
- Regulatory bodies ensure that drugs developed for clinical trials have all gone through the relevant testing for safety before they can be tested for efficacy
- Human Research Ethics Committees review all human clinical trials in Australia to ensure that the trial will be conducted ethically, all trial participants’ safety is maintained, that the trial is being conducted for scientifically or medically required reasons and that the integrity of the trial data will be maintained
- At all times, the benefits are assessed to ensure that they outweigh the risks
- Made up of experts on the condition related to the trial
- Often contain an independent person not linked to the trial sponsor or site personnel conducting the trial
- Supervise the trials and review all safety data to ensure that benefits continue to outweigh the risks
- Perform periodic reviews of trial results to determine if the trial is still safe to continue
- Nothing in a clinical trial is done without obtaining written, informed consent
- This involved you being provided with the Participant Information Sheet/Consent Form with enough time to read this and speak to your usual treating doctors and relatives/friends about the trial
- The Participant Information Sheet/Consent Form is a document that goes through what the trial is testing, what is known about the drug so far, what is required of you throughout the trial and what tasks will be done during clinic visits, what potential side effects can occur and what your rights as a trial participant are
- You are encouraged to write down any questions you have so the study team can discuss these with you
- Once you attend for the screening visit, study staff will go through the Participant Information Sheet/Consent Form with you and answer all your questions before you sign this document. If you are willing to proceed with participating in the trial, you will be asked to sign and date the document and the study staff member who went through the consent process with you will also sign and date the document. You will be given a fully signed copy to keep for your records
- Each trial is different, but all trials have reviews to assess you for safety and how the drug is working
- At your health care review appointments, you will be seen by study staff who will perform checks as per the requirements of the clinical trial
- Clinical trial health care reviews are often more frequent than usual standard of care appointments but this is to ensure you are regularly checked for safety and to ensure you are suitable to continue on the clinical trial
- This allows you to discuss your health with study staff regularly and we can provide updates to your usual treating doctors as required
- All review appointments are performed at no cost to you and your travel costs for trial appointments are reimbursed
- Clinical trials are completely voluntary from start to finish and you are not obligated to stay on the trial if you no longer wish to after you have signed the Participant Information Sheet/Consent Form
- If you commence the clinical trial and then withdraw, your relationship with Emeritus Research is not affected and there are no penalties for withdrawing from the clinical trial
- Your usual healthcare will not be affected
- In the case that you withdraw and you have received one or more doses of the study drug, we would ask if you would be willing to complete a safety follow-up visit for a final check on your health and to discuss your options after leaving the clinical trial
- You can still participate in future clinical trials if you withdraw from a clinical trial, but your eligibility will need to be assessed again for any new clinical trials
The thought of joining a Clinical Trial can be daunting. Let our professional and friendly team guide you through the process. Without volunteers like you, we would not be able to facilitate the development of new therapies to alleviate the sometimes debilitating symptoms of medical conditions affecting many people throughout the world.
Benefits of enroling in a Clinical Trial
- Gain access to leading specialists and experienced investigators conducting our trials
- Medications and clinic reviews at no cost
- Receive payment for your travel costs and time
- Work with a dedicated clinical research team
- Make an impact on medicinal advancements
Phases of a Clinical Trial
Phase 1
Test a new drug for the first time in a small group of people
Phase 2
Study the drug in a larger group of people to assess the safety and to determine a suitable dose
Phase 3
Compare the drug to other standard drugs in large groups of people to determine inferiority or superiority
Phase 4
Search for other diseases the drug can be used for and monitor longterm benefits and risks
