Clinical trials aren’t scary, dark lab experiments. They’re actually fundamental to advancing science and saving lives.
When my doctor first mentioned clinical trials for my treatment-resistant condition, I couldn't help but picture myself running on a hamster wheel in some dark laboratory. My first instinct was to associate them with fear, and I’m not the only one who thinks that way.
The Memorial Sloan Kettering Cancer Center (MSK) says that doctors hesitate to bring up participation due to the poor reception. Their data shows that only 40 percent of Americans have positive impressions of trials. However, they noted that education about clinical trials helped to significantly increase people’s positive impressions about them!
Now, as someone who has finally participated in a clinical trial, I know that they’re still widely misunderstood.
Let’s get started on demystifying the process and learn how you and I can actually help further science (and maybe save lives).
1. Not every trial has a placebo group
One of the top obstacles to getting participation in clinical trials is the possibility of receiving a placebo. In fact, in the MSK study, about 63 percent of both physicians and participants were concerned about being in the placebo group during a clinical trial.
Contrary to popular belief, many trials do not consist of a placebo group! A large number of trials being conducted, especially those in Phase III, give the same drug or treatment to a large group to confirm its effectiveness. They also compare the outcome to other treatments currently on the market.
2. Clinical trials have many different phases
Since we mentioned phases, let’s dig into what they are. There are three phases to each clinical trial before it gets Food Drug Administration (FDA) approval.
|I||Researchers test an experimental drug or treatment in a small group of people (20–80) for the first time. The purpose is to evaluate its safety and identify side effects.|
|II||The experimental drug or treatment is administered to a larger group of people (100–300) to determine its effectiveness and to further evaluate its safety.|
|III||The experimental drug or treatment is administered to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments, and collect information that will allow the experimental drug or treatment to be used safely.|
As you can see in the table above, there’s a difference in protocol and safety with each phase of a trial you participate in. And you absolutely have the power to choose which phase you want to enter.
3. You do not need a doctor to refer you
While I found out about my clinical trial during a routine office visit with my specialist, you can also search for answers yourself. Nothing is wrong with making sure you’re receiving the best care possible, even if it means looking out of the box.
You can start on websites such as Clara Health or ClinicalTrials.gov that list all trials that are currently recruiting around the world. These websites will supply you with contact information for studies so you can reach out to the researching physicians personally.
If you feel uncomfortable making such a big decision on your own, ask your doctor for their professional opinion. Browse these websites and have a few options to discuss during your next visit!
Keep in mind that you may participate, no matter what state or country you’re in.
4. You’re integral to our society and the future of medicine
Without participants willing to take part in studies, we would never have new treatment options! Clinical trials are how every FDA-approved medication or procedure has come into existence. Even the over-the-counter medications in your medicine cabinet have gone through clinical trials with human participants. Someone you’ve never met made that pain-relieving prescription a reality!
Clinical trials don’t have the same level of awareness as organ or bone marrow donations, but they’re just as important. People who participate in these studies can end up saving the lives of hundreds, if not thousands of people.
5. Your health is a top priority
Yes, clinical trials may scare you since they’re experimental with hypothesized outcomes, but the studies are sure to adhere to strict criteria. This aids in the safety and success of the procedure, drug, or intervention.
For me, nurses closely monitored me every 15 to 60 minutes. I saw the researching doctor, or a member of his team, daily during my trial. I felt 100 percent included in all decision making, and never once felt forgotten or unheard. The rules and regulations were more strictly observed compared to my normal hospitalizations, which I found really comforting during my experience.
Remember, if you choose to participate, you are the most integral part of the clinical trial. Your needs will always be met. Your questions will always be answered. And your comfort will always be the number one priority during your participation.
Researching physicians must frequently report to the National Institute of Health. This ensures that trials with too many adverse outcomes get terminated.
6. You can back out of a clinical trial at any time.
Many people are worried about committing to a trial for fear that they can’t back out once accepted, but that's not the case. If at any time during the trial you feel uncomfortable or decide that the treatment is something you no longer want, ask to unenroll. Neither you or your care will be penalized.
An uncomfortable situation isn’t ideal for either party, especially when it’s for research purposes. Do what’s right for you.
7. You won’t be taking drugs or procedures you've never heard of
Many clinical trials are simply exploring current FDA-approved treatments or drugs for an illness they aren’t currently FDA-approved for. This means that the trial will have people have a procedure, or take a medication, to treat a disease that’s currently considered for “off-label” use. For example, I underwent a Hematopoietic Stem Cell Transplant (HSCT), which is currently FDA-approved to fight blood cancers.
However, my illness, systemic sclerosis (scleroderma), isn’t FDA-approved to be treated with an HSCT, so I had to get this treatment through being part of a clinical trial. The trial’s objective is to study the stem transplant’s effectiveness in people with systemic sclerosis versus those with blood cancers.
A drug or procedure like this must complete the entire FDA clinical trial process just like it did for the previously approved use, in order to be approved as a different treatment.
8. Clinical trials don't take place in sketchy labs
Remember my fear of being a guinea pig? The fear of that dark laboratory where anything could happen? Upon actually participating in a trial, that fear was quickly dispelled.
Most clinical trials frequently take place in hospitals or medical clinics. Chances are, every hospital you’ve visited has housed multiple clinical trials.
For my trial experience, I was on a beautiful, newly remodeled oncology floor at one of the nation's top hospitals. Not all trials are inpatient, though. Trials can be outpatient, too.
Personally, I’ve never felt more secure during a hospitalization. A medical professional was available to me at all times, and any adverse events that arose were quickly managed. I had everything I needed emotionally and physically at my disposal.
To my surprise, the entire process felt no different from any other hospitalization or procedure. It was probably the best care I’ve ever received!
9. Insurance will often pay for clinical trials
Many negative feelings stem from the large price tag associated with these experimental trials. With the proper team willing to go to bat for you, insurance coverage is often granted for these treatments. Sometimes it may take a few denials and appeals, but persistence can pay off.
In some instances, if the trial is sponsored by a drug company, there may be no cost whatsoever.
I was able to have my entire HSCT, the pre-evaluation testing, and the post-transplant care covered once I hit my deductible and out-of-pocket max. The trial was treated by my insurance like any other procedure I’d received in the past because of the letter proclaiming medical necessity completed by the researching physician.
10. Clinical trials are not a “last resort”
There are thousands of clinical trials taking place around the globe. Trials range from exploring new meditation techniques to lower blood pressure, to undergoing experimental surgeries.
Clinical trial is just a fancy name for "international studies," which can include:
- the use of a new drug
- the use of a drug in a new way
- experimenting with behavioral adaptations
- surgical procedures
- the use of new medical devices
They’re not done solely as a last resort for when all treatment options have been exhausted, though that can be the case. There’s a little something for everyone looking to branch out of the “standard care” offered by their doctor.
Since participating in a clinical trial, I see them in a much different light. My quality of life has improved immensely, which is something that nothing currently on the market could successfully do for me. Because I was willing to dive into the unknown, I received — what will hopefully be the golden standard of treating refractory autoimmune disease — years before it sees FDA-approval. I have shed three medical devices, and have a brand new, completely rebooted immune system!
The HSCT exceeded my expectation and made me feel human again when I had lost hope of that ever happening. Clinical trials provide a level of treatment that nothing on the current market can achieve, and that’s the point!
While adverse events do occasionally accompany these trials, it shouldn’t put you off from looking into your options. And clinical trials are a valid option.
Don’t be afraid to dive into the unknown. Sometimes that’s where miracles await! A trial saved my life and will hopefully save the lives of people who will be around long after I’m gone.
Chanel White, aka The Tube Fed Wife, is a blogger sharing her personal journey with an aggressive form of mixed connective tissue disease. After failing all treatment options available, Chanel underwent a clinical trial that surpassed everyone's expectations. For the past four years, she’s been a steadfast patient advocate, motivational speaker, and freelancer who’s been on major outlets like the BBC and The Huffington Post. Chanel sits on the board of multiple non-profits and dedicates her time to demystifying the clinical trial process. Find her on social media @thetubefedwife.