by Barby Ingle – This piece has been entered in the Patients Have Power Writing Contest run by Clara Health designed to raise awareness about clinical trials. I am passionate about this cause and hope it will help raise much needed awareness about the power of breakthrough research.
I’m going to be sharing about clinical trials and my experience with them. One of the topics I get asked a lot about is clinical trials because I’ve participated in multiple clinical trials over the years so people are naturally interested in what I can share on want is needed and what I know about clinical trials.
I know about and I’m working on right recruiting for a few clinical trials now. I am sharing to help demystify clinical trials process and reverse the “I don’t want to be a guinea pig” stigma associated with participation. Currently I am helping on sciatic pain, herniated disc, eczema, ulcerative colitis, cluster headaches and uterine fibroid trials. I don’t have all of these conditions personally. I do have a wide reach in the pain community and all of these conditions have a connection to others I work with or myself.
Clinical trial creation, evaluation, and participation is definitely something that I have paid attention to and have had to learn a lot about not just because of myself but also because of the position that I hold with the international Pain Foundation, as the President. I definitely have some notes up here for each of you. I raise awareness about clinical trials and breakthrough research because this helps the future of care for me and all humans who face a chronic, rare or debilitating condition.
I am going to share my tips for each of you using the herniated disc-sciatica trial as the example, but these are tips and tools that you will want to apply to any trial you are interested in.
So many people are trying to decide if a clinical trial is right for them and if it is appropriate for them. We need to humanize clinical trials so understanding the process and what to look for is important. Some of the things to maybe look for if you are going through a clinical trial. If you are deciding to go through a clinical trial there are some things that you want to know. The first thing is what’s actually being studied.
I know that there’s some patients that were not even included in trials appropriately because the trial was set up to test something else. And what we need in a clinical trial was not there. That happens in many of the trial areas. So, you want to make sure that you know what’s being studied and if you fall into the category.
Next, ask about logistics. Do I have to leave my house? Is it a clinical trial for medication? Is it a clinical trial for durable medical equipment? Is it a clinical trial for something that you have to be in the hospital for a few days for or can you go to the doctor’s office to accomplish that? You should definitely ask a lot of questions about it before you get involved into a clinical trial. How often do I have to go? I have done quite a number of clinical trials myself and some of the things that I watch for are how long this study lasts and how much do I have to be involved. Is there any compensation for these studies? Some of them have compensations, some of them don’t. So, it’s definitely something to look at and get involved with if you are comfortable and it meets your needs as well.
“Where Can You Go to Learn More About Clinical Trials.”
There is a few places that I prefer and really like the first one is on the FDA website and that link is www.clinicaltrials.gov. The other one that I really like and I have been involved with for quite a number of years I think going back to at least 2014 is Cure Click and their website is www.cureclick.com and the third is www.clarahealth.com. I really like most of these trials and actually, International Pain Foundation puts out daily messaging about different clinical trials that are going on currently that might have to do with the chronic pain community. I am currently helping to recruit for a trial that I believe is an innovative clinical trial running in the United States and Japan. It is a one-time treatment trial that has a placebo element, meaning it is a double-blind study.
“How Do You Know If A Clinical Trial Is A Good Trial?”
First off, can you find the trial on the FDA web site? Now it is important to remember that not all trials on the FDA web site are great trials and that might not be a fit for you but that is where you can go to check first. Now some people, scientists and medical organizations host trials that are not necessarily scientific in nature so you want to make sure that you’re getting involved in something that has backing that has been vetted in and has been looked through to make sure that it is a good trial.
A good trial gives you informed consent. You will want to find one that has informed consent. These are pieces of information that the trial hosts are expecting to happen. But you also want them to say, these other things could happen as well. So that you have some information on what to look for in between the different parts of the trial and that you have consent as to what you may experience. You want to know, ‘okay, I’m going to sign these informed consent papers don’t just sign – I’m actually reading them and make sure that I am okay with everything that is presented’. You want to see and know what you’re getting into.
Some trials tell you a specific information for instance, the sciatica – herniated disc clinical trial is one you have to be between the ages of 30 to 70 and so if you’re younger than 30 or older than 70 you wouldn’t be a good fit for that trial and they’re going to screen you out. This is another way to tell if it is a good trial. Is this clinical trial trying to create a tool for patients to use long-term? Ask if the trial is even looking at what the patients are needing with this condition. Is this a friendly trial? Is this something that you can quit? Most good trials you should be able to quit the trial if you need to or decide that you no longer want to participate for any reason. If you start the trial and it’s not right, you should be able to leave the trial. That’s one of the things that you should watch for.
Another interesting piece about the sciatic trial is it is based out of Japan. In Japanese they don’t have a word for placebo. The closest word is ‘sham’. So, they call placebo, ‘sham’ which I found quite interesting when I was looking and researching this study and knowing that they use the word sham even here in the USA trial information. If you see that on the on the website with the information know they want this trial to be able to be used by Japanese patients as well as American patients and accepted by both governments as a foreseeable future treatment coming down the line. They have to use the words that get that covered approval for both countries.
I am going to leave you with the link to the sciatic in herniated disk option (https://curec.lk/32FjilR) because I’ve talked about that the most here but there are other trials you can look into. I will be back again sharing more on clinical trials and other options that are available in the coming weeks and months.