The “unknowns” of clinical studies drive many people to look elsewhere for treatment, but did you know clinical trials come with some pretty unique benefits? They can offer medical treatment and visits with a doctor at no cost, insurance is not needed and you may actually be compensated.
This Beginner’s Guide will tell you what a clinical trial is, its purpose, and who’s there to protect your rights along the way. (We’ll stick to information regarding clinical studies for dermatology because that’s what we know best!)
Why Do Clinical Trials Exist?
In short, clinical trials exist so non-FDA approved drugs can be approved to sell to the public. It may be a drug that’s brand new or a generic version of a drug already available. Studies can take years and are focused on collecting mounds of paperwork holding data that answers these questions:
Is the drug safe enough for the public?
Does the drug do what it is telling the public it can do?
What are the potential risks (short term and long term)?
The 3, Important Clinical Trial Phases
The product moves through 3 phases - conveniently named Phase 1, Phase 2 and Phase 3. These different phases move the drug closer and closer to the final goal of receiving a stamp of FDA approval to sell.
Phase 1: Tests the safety and dosage.
Phase 2: Tests to see how effective the medication is and notes any side effects.
Phase 3: Continues tests to see how effective the medication is and monitors any dangerous or unexpected reactions to the drug.
Try This!: If you’re considering a clinical trial, ask them what phase the study is in. This will give you an idea of how much research has already been done on the drug.
Who Runs The Clinical Trial?
There are three groups that play major roles in running a clinical trial: The drug manufacturers, the clinical research sites and the ethical review boards.
Drug manufactures are the ones making the request for a clinical trial to take place. They are also the ones who are sponsoring, or paying for, the study.
Clinical research sites are the locations that the participants are physically going to be tested and receive the investigational drug. This can be a hospital, private research site, or university.
Ethical Review Boards are there to make sure the public is protected during this process - from advertising the clinical trial to making sure participants who enroll know their rights.
Can Anyone Be In A Clinical Trial?
Most times, but not always, the participants will need to have the condition that the drug is being tested for. For example, if the drug is being tested to clear eczema, the participants are most likely going to need to have eczema. The exception to this is when a drug is at the beginning stages. During this stage, the study may be searching for anyone who is healthy to participate.
Each study comes with a unique list of inclusions and exclusions - criteria you must meet and criteria you must not meet. Inclusions may include age, severity of the condition, and weight. Exclusion may include past medical history, current medications and lifestyle.
Aside from your health, you will likely need to be located near the research site, as part of the study’s requirements will include going to a certain number of appointments at the office site.
Top Tip: Call the office to get any of your burning questions answered! The clinical trial staff members are there to answer any and all questions you have throughout the entire process (even if you don’t enroll in the study). After all, without you, there is no research trial!
Still have a few questions? Email us at firstname.lastname@example.org or call us at (760) 203-3839 x102 and we’d be happy to help!