Mar 27

4 steps to joining a clinical trial

How to become a clinical trial volunteer

Because of what it implies, few people are willing to become a clinical trial volunteer. It is known that, by joining a clinical trial, you expose yourself to possible risks or side effects. Clinical trials are the last step of drug development (sometimes also health devices), and are required before any new drug can be release onto the market. New drugs can be released only if they are proven to be safe for the population and if they show a good efficacy for the targeted disease. Safety data of a new medication on animals is insufficient for its approval by the FDA or other health authorities. Hence, the only way to demonstrate its efficacy and safety is by testing on humans. Therefore, clinical studies are essential to the development of new drugs and treatments. This is why many clinical trials volunteers get involved in the hope they can help other people. If you wish to become a clinical trial volunteer, here is a 4-steps way to joining a clinical trial.

Clinical trials are necessary to determine approval or not of a new drug onto the market

First step – Are you healthy or do you have a specific disease or illness
First thing you need to know: you can be a healthy volunteer, which mean you do not have to be ill in order to join a clinical trial. There are 4 phases in a clinical trial, called Phase I, Phase II, Phase III, Phase IV. Phase I of clinical trials usually involve testing the new medication on healthy volunteers to study its safety on human use. Phase I typically tests for changes in blood work, changes in vital signs, changes in electrocardiograms, short term side effects and any other reactions that can be linked to the investigational drug. Because of the unknown reactions or side effects of the new drugs, Phase I clinical studies tend to compensate generously people who volunteer. Phase II and Phase III of clinical trials generally involve patients (with the targeted disease or illness). During Phase II and III, more safety data are collected, but other goals, such as studying the efficacy of the new drug, how they work in human, the best dosage and way to administer it, its excretion, etc. Phase IV are “post-approval” studies. After their approval by the FDA, pharmaceutical or biotech companies often do phase IV studies in order to collect more information on a larger cohort.

Second step – Determine the clinical trials that suits you
Unlike many believe, chances are that there will be a clinical trial that will suit you. Clinical trial volunteers are welcomed in many fields : migraines, sinusitis, allergies, leukemia, obesity, etc. There are studies for almost every condition that needs a treatment.

Third step – Finding and joining a clinical trial
Many resources are available for you to find a clinical trial. The best place is to start here, on the internet. Several websites offer good directories of centers that run clinical trials, or the active studies. They also allow you to specifically search for an illness, such as migraines or allergies.

Fourth step : Joining a clinical trial: eligibility
When you find a study of interest, make sure you read the eligibility criteria. Is the clinical trial you are looking at enrolling only healthy clinical trial volunteers, or are they only looking for sick patients. Are they looking for men only, or women only? What is the age group they are targeting. Are there other criteria, such as smoking, history of other diseases. Look for the `Contacts` to find where the studies are being conducted and contact information of the center running the clinical trial, or to ask any other relevant question.
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What else do you need to know?

Will the sponsor pay for your travel if you are coming from far away (another city or state) to volunteer.

Make sure you read the consent form carefully and ask the staff to explain all the procedures that will occur during the trial, to avoid any surprise

Know your rights. As a volunteer, you always have the right to withdraw consent from the trial, this at all time. Although, you do not have to give an explanation when withdrawing consent, is it always better to inform the sponsor of your reasons behind it, so they can document it and readjust their goals and next studies if needed. Also, both sponsors and health authorities need to know if there were any abuse or bad treatment from the center conducting the trial.

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