A very important part of the medical system that isn’t talked about a lot are clinical trials. Without this research, our medications wouldn’t be available, we wouldn’t know as much as we do about various conditions, and we wouldn’t have as many treatments as a whole available. These are so important, but they’re also rarely talked about. Today, I’m going to help demystify clinical trials to help you understand them, as well as provide you with resources to find clinical trials that you may want to participate in. There are many things that patients don’t have control over – our own bodies and their reaction, for one – but at the end of the day, patients have power. We are a critical part of clinical trials, and these trials are a critical part of helping other patients. We are powerful.
This is an entry to a contest.
What are clinical trials? The NIH describes these as “research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people. Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment” (x). Every single treatment goes through at least one clinical trial. Yes, every single one! That’s required by the FDA (in the US). This makes clinical trials crucial for everyone in the US. If you don’t have a chronic condition, you never know when you’re going to, when you’re going to get an infection, or when someone you care about will.
Why should someone try one? There are a variety of reasons. Maybe you’re not responding to other treatments. Maybe an available treatment isn’t advised for someone with a medication condition you have. Maybe you had bad side effects from the available treatments. But some clinical trials do more that finding new treatments. “Other clinical trials test ways to find a disease early, sometimes before there are symptoms. Still others test ways to prevent a health problem. A clinical trial may also look at how to make life better for people living with a life-threatening disease or a chronic health problem. Clinical trials sometimes study the role of caregivers or support groups” (x). I was watching the news a few weeks ago when they did a story on a woman who was diagnosed with Alzheimer’s before she started having symptoms because she signed up for a clinical trial that took MRIs of people’s brains for years to track what pre-Alzheimer’s MRIs look like. There are lots of reasons to try a clinical trial!All about clinical trials, plus resources to help you navigate them. Click To Tweet
How do they work? There are four phases to clinical trials, which is why it can take so long for a medication to be approved after it has been discovered/created. Phase I tests the treatment on a small group of healthy people (usually) to test its safety, side effects, and dosage. Phase II tests its efficacy on a larger group. More specifically, “This phase aims to obtain preliminary data on whether the drug works in people who have a certain disease or condition. These trials also continue to study safety, including short-term side effects” (x). This phase can take years (years!). This is the phase that we tend to think about when we think of clinical trials. Phase III tests the treatment’s safety and effectiveness with more nuances, such as testing different populations and dosages, as well as testing whether it works in conjunction with someone taking other medications. In this phase, they test the treatment on anywhere from several hundred to several thousand people. This is the last phase before approving the treatment for public consumption. Phase IV monitors the treatment’s safety and efficacy on larger populations, as side effects may not become clear in earlier phases. (All information in this section comes from this page.)
Why I might try one – I know that a lot of people might worry about being a guinea pig by participating in a clinical trial. But as you can see from this post, that isn’t often the case! Aside from the fact that many studies involve observing people instead of trying a new treatment, you’re not a guinea pig for participating. I see a very real possibility that I’ll participate in a clinical trial in my lifetime. A big problem that I’ve experienced in my life is that I don’t respond to many RA treatments. In fact, I’m on the only main treatment that I respond to. All the medications you see advertised on TV for RA? I don’t respond to them because most of them are TNF inhibitors. Back in 2016, we weren’t happy with my RA treatment, so I tried a new medication. My body responded badly and I went to Rituxan, a B-cell inhibitor. My rheumatologist and I decided to stick with Rituxan until another B-cell inhibitor is approved. But the (unfortunately) very real reality is that I may stop responding to Rituxan at some point. If there are no other B-cell inhibitors available, what do I do? Sign up for a clinical trial. This isn’t something that I want to do right now because Rituxan is really working at the moment, but I’m keeping research opportunities like clinical trails in my back pocket just in case.
Current clinical trials – I looked through some sites to see what sort of trials are currently being held or recruiting to give you guys some examples. One that is interesting to me is called Discovering the Antecedents of Rheumatoid Arthritis Flare (x). This is one study that is not about trying a medication and is instead looking to see any patterns that might indicate an RA flare is about to happen. They began this in 2014 and are estimating to end it by 2020. Another study is one looking at “the safety and long term efficacy of Filgotinib,” a new RA medication (x). This medication was created by a Belgian company and is in Phase III of the trial. Because this is a JAK1 inhibitor and not a TNF inhibitor, maybe one day I’ll be on this medication. I also looked at clinical trials for POTS, as I developed it last year and it’s a tricky condition. Current studies include one investigating exactly how beneficial a high-salt diet is to POTS patients, one testing new medications for POTS patients, and another studies GI symptoms in POTS patients.
Other resources – ClinicalTrials.gov is “a database of privately and publicly funded clinical studies conducted around the world (x). You can look at studies currently recruiting or all of them, search them by condition or by drug name, and even look at the country in which the study is happening. Another site to check out is Clara Health (www.clarahealth.com). They can help you find a trial, work with your insurance, arranging travel, and more, all for free. You create an account with them and they help you find clinical trials that fit your needs. Clara Health also has lots of guides to help you!
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