LUPUS CLINICAL TRIALS
When you read the words “clinical trial” what is your initial reaction?
If you and I are similarly minded, I would assume the words: draining, inconvenient, and scary might come to mind. Correct? Additionally, you may even go deeper into the depths of your imagination and find yourself visualizing some eerie laboratory where scientists order you to swallow some big mysterious pill, as doctors study you behind a one-way glass mirror.
I think the reason many of us conjure these thoughts about clinical trials is that we simply are not given enough information about them, and in the absence of information, we tend to fill in the gaps of what we think we know about them. Which, thankfully, is not 100% accurate. I would venture to say, not even close.
It's time that we know the truth and debunk the unknown about clinical trials, and even more specifically LUPUS clinical trials.
WHAT IS A CLINICAL TRIAL?
A clinical trial is a type of research that studies a product given to people. Clinical trials study how safe and helpful a product is. When a product is found to be safe and helpful, it may become standard of care in the near future - improving the lives and often saving the lives of patients, not just in the US, but all around the world.
In order to be able to discover a new drug for lupus relief, or attempt to improve a patient's quality of life - a medication has to be tested on people, then approved by the Federal Drug Administration. The Federal Drug Administration or FDA for short, is a federal agency of the United States Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, bio-pharmaceuticals, blood transfusions, cosmetics, etc.
Before Benlysta, which is a biologic medication designed specifically for lupus and approved by the FDA about 8 years ago, it had been over 50 years since there was last made a drug for lupus patients. Currently. there are only 4 medications approved by the FDA to treat lupus. They are Aspirin, Hydroxychloroquine, Corticosteroids, and Benlysta.
Now, many of us take other medications to help with our lupus symptoms, and those medications are approved by the FDA, but they are not approved specifically for lupus. For example: methotrexate is approved for the treatment of rheumatoid arthritis; therefore, it is considered an “off label” drug when used for lupus symptom management. Imuran is approved as an anti-rejection medication for someone who has had an organ transplant, therefore; it is considered an “off label” drug as well, when used to treat SLE or lupus nephritis.
This is why clinical trials are not only necessary, but essential to helping lupus patients. More medications need to be designed for lupus. Furthermore, if a cure is to be found, it will not be executed unless lupus patients participate in clinical trials.
THERE ARE TWO MAIN TYPES OF CLINICAL TRIALS:
A Controlled study means that there is one group of patients who receive the new product and another “control group” who receives a placebo. A placebo is an injection, infusion or pill that seems identical to the new treatment, but is inactive and it doesn’t do anything. Controlled studies are typically conducted as “double-blind trials” which means that neither the physician nor the patient knows which group is receiving the new drug and which is receiving the placebo. This is so there is no possibility of persuasion, or interference with the trial. By having one group that gets the new product, and one that consumes the placebo, the scientists and researchers can compare the effect of the new product.
The other type of clinical trial is called an open-label clinical trial. With an open-label trial, they do not attempt to disguise the new drug or treatment. No placebo “or fake inactive pill, shot, or infusion is given in an open-label clinical trial. It is just the medication and there is no mystery whether you are receiving it or not. You are.
WHY PARTICIPATE IN A CLINICAL TRIAL?
If you want to help find a cure for lupus, contribute to moving science forward, receive the newest treatments out there, and additional care - participate in a clinical trial.
The majority of research takes several years and a large cause of this is the recruiting process, screening (if the patient is able to participate in the trial), and the enrollment of patients.
For some studies, it may take more than one year to enroll patients into a study! This is why it is so important that we do what we can to participate and bring awareness to these studies!
Unfortunately, information on how to participate in clinical trials is very limited. Per FDA guidelines, clinical trials are not allowed to have ads on social media, TV, radio, or webpages. The only way to become aware of clinical trials is through your healthcare providers, through lupus research organizations, and their affiliates.
WHAT TO EXPECT DURING A CLINICAL TRIAL:
Most clinical trials are very specific. They may be looking for lupus nephritis patients who have stage 2 kidney disease activity, but have never taken Cellcept. Or they may be specifically looking for African American females with discoid lupus and SLE. In the beginning, you will need to answer a lot of questions, and be vetted obviously to qualify. This is not meant to be exclusive, but your answers will help determine if you are a fit for the trial.
When you participate in a controlled study or open-label clinical trial you will usually need to visit the clinical trial site regularly to assess the progress together with the trial staff. There are sites all over the US, in fact, one trial could have multiple locations. You could be doing a trial in Texas and have a friend doing the same trial in California, however, you will be under the supervision of the hospital site you are reporting to.
How to find the right clinical trial for you? – What do you need to be aware of?
The Lupus Research Alliance and Lupus Therapeutics (an affiliate of the LRA) have a webpage that is designed to spotlight important clinical trials. They also have a program called PALS that should be launching this Summer.
PALS stands for Patient Advocates for Lupus Studies
The PALS program is in its pilot-testing phase at six academic medical centers
The goal is to have individuals living with lupus who have personal experience with clinical trials to serve as peer advocates for clinical trials
So if a patient is nervous, just needs to talk about the experience, has questions or concerns, they have someone by their side...being their friend, cheerleader, encourager to help them through.
For more information about clinical trials, here are some important links:
Easy FAQ and Answers form the National Institutes of Health including a list of questions to ask your doctor or the clinical trial staff: https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics
Pre-release that explains the background of many of the clinical trials that LRA and Lupus Therapeutics have initiated: https://www.lupusresearch.org/lupus-research-alliance-announces-published-data-showing-effective-approach-drug-repositioning/
Lupus Therapeutics homepage – showing clinical trials and the PALS program: https://www.lupusresearch.org/research-and-clinical-trials/therapeutics/
Find a clinical trial near you that is part of the LuCin Network (check out the “Create your personal trial list” on the right hand side): https://lupustrials.org/find-a-trial/
ORKIND Clinical Trial on Omega 3 Rich Krill Oil
**All resources provided by this blog are for informational purposes only, not to replace the advice of a medical professional. Kelli encourages you to always contact your medical provider with any specific questions or concerns regarding your illness. All intellectual property and content on this site and in this blog is owned by morethanlupus.com. This includes materials protected by copyright, trademark, or patent laws. Copyright, More Than Lupus 2019.