Clinical Trial Chronicles: 8 Things You Need to Know Before Signing Up
There are a few reasons why people decide to join a clinical trial; One reason is that it's a cheaper way to receive treatment while living with psoriasis. Other people use it as a way to give back to the psoriasis community by sacrificing themselves to pave the way for others to receive better and effective treatments. I spoke with Johnathan Weiss, M.D of Gwinnett Dermatology in Snellville, Georgia on the process of clinical studies.
How are clinical trials approved?
There are four phases in clinical trials before a treatment is approved by the Federal and Drug Administration. In the first phase researchers choose a small group to test the treatment on, if all goes well the study moves on to an additional phase, which requires new individuals for the study. During these phases, the efficiency, effectiveness, safety, and side effects of the treatment are tested. Depending on how things go in the trials a treatment may or may not be submitted to the FDA for approval. After the clinical trial is over and its findings are submitted to the FDA, it takes the department around 30 days to approve or deny.
The recruitment process
“Advertising through mass media, the internet, television, radio, newspapers. There is also a company that has collected a database of names and they can get us patients as well," are a few of the ways Dr. Weiss advises people living with different conditions are recruited. But if you are interested in seeking a study on your own here are a few resources. The National Psoriasis Foundation has a clinical study database where you can search for trials in your area. The information provided will tell what phase the study is in, the treatment they are testing, and the qualifications/requirements. You can also check out www.clinicaltrials.gov for current opportunities.
How are individuals chosen?
It depends on the needs for the study. For some clinical trials there are stipulations which could include not being on certain drugs prior to the research. For example, some studies advised if you have been on a biologic in the last 6 months, you may not be eligible to participate. Each study has a set of criteria so it's important to research and look at the fine print.
How long will the trial last?
Dr. Weiss advises that an initial trial will last around 3 months. The length of time for testing a treatment can be different depending on the type of drug being studied. Some treatment requires more time than others.
You could receive a placebo
A placebo is defined as a treatment that has no active ingredients or components, but is made to look identical to the treatment being tested. This is given to the control group of the study. This group is used in comparison to the experimental group, the individuals who receive active treatment. If you decide to enter a trial you will not be made aware of which group you are in, which means you could be in the control group that receives an inactive treatment.
It effects the entire family
Justin Womack an individual living with psoriasis entered a clinical trial and the risk effected both him and his wife, "We are at the point where we would like to have kids. But while on the clinical trial I had to sign a contract which stated I would not impregnate my wife while participating in the clinical trial… It took a toll on us because the one thing she really wanted was a child…” Justin was advised that after the trial he could proceed to attempt to have kids if he chose, but the long term effects were still a huge concern. Women who enter a study are put under these same restrictions as well. Dr. Weiss advises, “That’s to protect the fetus, not to discriminate against women.”
How often does one have to receive lab work?
Again this varies depending on the treatment. A drug such as a topical that's simply applied to the skin is not going to require as much lab work as a biologic which basically reconfigures your immune system, the risk are different. The more of the risk, the more lab time. A study on a biologic could require weekly to monthly visits to the doctor providing research. It's important to ask yourself the following questions:
How much time will this require me to take away from work?
How much gas will I spend on traveling back and forth for doctor visits?
What happens after the trial is over?
So what happens to your quality of care and treatment once the treatment is approved and is available to the general public? "We try to get the patient in the system for approval of the medication by their insurance company before they actually need it,” says Dr. Weiss. Some companies will provide the treatment at affordable prices for 2 years which gives the individual time to get insurance or their finances in order. It's important to create a plan with your doctor on what will happen when the trial is over.
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