Irene is a 71-year-old individual who struggles with atopic diseases and has had active eczema for most of her life. Although her daughter and grandson have also had bouts of childhood eczema, they have managed to keep it under control and in remission in adulthood. Irene has a twin sister whose eczema mostly went away after the age of 10, but three of her five children have eczema and it now plagues (to varying degrees) at least five of her ten grandchildren. At least two of these three generations have participated in clinical trials at one time or another, realizing that the opportunity to have multiple family members with the same disease participate in scientific studies was a boon to researchers.
The helplessness I felt once I realized my eczema wasn’t going away any time soon made me want to get involved in searching for my skin’s salvation. I needed to feel I was taking a proactive role. It was difficult to do nothing just as it is difficult for a passenger in an automobile to keep from telling the driver how to drive. It’s not that I didn’t feel my doctors were doing their best to treat me, I just knew that it was more my fight than theirs; I wanted new and better treatments for my fractious skin. Participating in a clinical trial allowed me the best chance to “suit up and get in defensive formation.” If anybody ever literally had “skin in the game,” it was me.
The biggest challenge I overcame in clinical studies was even qualifying. Because of all the safety rules in place to keep patients from harm, the study criteria for who got to participate was determined by such factors as age, location, extent of eczema (or lack of it), and eagerness to faithfully show up with all of the test medications on scheduled visits, fill in your patient diaries, and abstain from all topical and oral products not allowed to avoid “contaminating” your results. In the past several years I have not been eligible for many studies because I’m too old.
Realizing that somebody cared enough, for whatever reason (perhaps altruism or financial gain alike), to want to make my skin heal was a serious incentive for me to engage in these trials. The word trial has many meanings here: yes, we were part of a trial in the investigative sense, but they truly were trials of endurance for both the researchers and the patients. So much work and so much hope goes into these ventures for all concerned, and the possibility that a study drug or treatment will not work and may even harm hangs like a malevolent spirit over all of it. Personally I have experienced both good and bad results over the years, but I hasten to point out that most studies were beneficial to me in some way.
When you are interviewed for possible participation in a clinical trial, you are given a very extensive list of questions to answer. It is very important that you do not give the answers you think your physician will want to hear just so you can participate in this study. It is agonizingly difficult to have this “magic bullet” dangling in front of you, so close and so full of promise, and not want to see what it can do for your eczema, but all of these seemingly random questions are asked for a specific reason and they do matter. Not telling a physician about a prescription drug or over-the-counter supplement you are taking can sometimes have a significant effect on how the study drug will work for you.
In this same vein, you may find that sometimes your re- searcher will have a widely differing opinion from yours of how your skin looks on each office visit. To that, I can only say, it’s your skin—you live in it day in and day out—and if you think it looks better (or worse), say so and stick to it. These studies are supposed to be objective in their entirety. I think it is as difficult for research physicians as it is for us patients to step away from expecting perfection and total healing from a medication or treatment, but these studies will be more accurate if they truly represent what each of the participants, whether researcher or patient, sees and records.
What is most important is to never forget that clinical trials are exactly that—trials. They are not a guarantee of success. by participating you are helping author your own story about how your skin reacts to new treatment, and that is a substantial achievement in any one’s book. And you may have contributed to not only your own benefit, but you may very well have helped to heal millions of others with eczema.
Ben (*not his real name) shared his comments with a request for anonymity. The National Eczema Association understands that many individuals with eczema choose not to be “public” about their disease, and so we honor this preference. Ben is a man in his 30s who has had severe eczema on and off since birth. There is no other history of eczema in Ben’s family.
My view is that because of a lack of scientific research and development in the treatment of eczema/atopic dermatitis over the course of several years, most dermatologists and medical practitioners only have a limited set of drugs and treatments to offer to patients suffering from severe eczema. In most cases, patients do not gain any long-term relief from the disease from such treatments. I participated in a clinical trial to avail myself of potential new treatments that are otherwise generally unavailable, but have shown promise in treating severe cases of eczema.
There are certainly challenges in participation. First and foremost, there is the uncertainty of using a new medication that a patient may never have had exposure to and that may not have a significant history. In most instances, a patient has to stop using any medications in their existing regiment of treatment while in the trial, which can also be quite difficult. Also, there can often be physical discomforts such as skin biopsies.
The level of care I received being part of a research study in a university setting was very high—higher than one would typically receive in the ordinary course of dermatological office visits. Additionally, there is a certain gratification obtained in participating in research that may ultimately lead to more effective treatments for the disease. We will only reach a better state of treatment in eczema/ atopic dermatitis through sustained investment in new drugs and research. Clinical trials are a key part of that.
My advice would be to fully educate yourself regarding the medication or treatment you will be receiving as part of any study, as well as the study structure itself. also, it is imperative to feel fully comfortable and have open communication with the administrators and medical practitioners you will be dealing with. Finally, have contingency plans if the study does not work for you.