Thinking About Joining a Clinical Trial for Psoriasis? 5 Facts to Consider
We share the benefits and drawbacks you need to know before signing up.
If you’ve been toying with the idea of volunteering for a clinical trial to do a little good for the greater psoriasis community, you’re in luck. Since psoriasis affects more than eight million Americans, there’s always research being done on a full gamut of therapies—systemic medications, topicals, and so on. By signing up, you could help give doctors a better understanding of the disease, and equip patients with more potential options to manage their psoriasis. And it might just benefit your personal psoriasis journey, too. But there are some drawbacks, such as time, eligibility, and the possibility of drug side effects.
We enlisted the help of several experts to get the lowdown on psoriasis clinical trials and what they entail. Here’s what they had to say.
Participating Can Bring New Therapies to You and Your PSO Community
Almost every dermatologist out there will encourage their patients with psoriasis to participate in a clinical trial if they have the opportunity. “These trials are the stepping stone to providing more therapeutic options for patients with this lifelong condition and can improve quality of life,” says Kamaria Nelson, M.D., a board-certified dermatologist at The GW Medical Faculty Associates in Washington D.C. According to Dr. Nelson, one of the main benefits of being involved in a clinical trial is that you—the participant—have access to cutting-edge treatments and technology, sans the hassle of having to deal with insurance coverage in most cases. Additionally, she says, participating in a trial can give patients a sense of empowerment as it allows them to have a more active role in their healthcare. “You’re also helping others get access to new treatments in the future,” she notes. “And that’s huge.”
Annie Gonzalez, M.D., a board-certified dermatologist at Riverchase Dermatology in Miami, FL, agrees: “Psoriasis clinical trials can give patients first-hand access to a treatment that may deliver clear or near-clear skin and decreased systemic inflammation. Additionally, they offer new potential therapy options for patients whose other medications stopped working after a while.”
There’s a Screening Process and You Might Not Make the Cut
Participating in a clinical trial isn’t as easy as just signing up. First things first: You have to actually find one, which you can do by asking your dermatologist or by using the National Psoriasis Foundation’s handy Clinical Trial Finder tool. This tool helps you narrow down studies based on your age, where you live, and so on. Currently, they have more than 250 trials listed to choose from!
Once you’ve found a trial that seems suitable, you’ll then have to go through the process of getting screened by a doctor first to ensure your eligibility. “Criteria may include how long you’ve had psoriasis, how much of your skin is involved, and what treatments you’ve used in the past,” Dr. Nelson says.
Additionally, they take into account the type of psoriasis you have—as well as whether you have psoriatic arthritis—and how severe it is, as well your age and gender, because these are all factors that play into whether someone will be right for a trial or not. Speaking of which, you should also consider what’s right for you personally before getting involved in a trial. Some questions to ask yourself: Are you willing to make the drive or even relocate? Are the risks worth it? And do you have the bandwidth?
OK, now let’s say you were successfully screened and given the go-ahead to be part of a clinical trial—here’s what you should expect. There are four main stages. In phase one, studies involve roughly 20 to 100 participants to observe the safety of the drug; this can take up to several months. If the medication’s safety is approved, the trial can move on to phase two, which usually includes several hundred volunteers trying the medicine to examine its efficacy, as well as side effects. This can take several months, or up to two years. In phase three, physicians monitor efficacy and adverse reactions in up to 3,000 people and study the effects in various populations and at different dosages. The U.S. Food and Drug Administration (FDA) will then approve the treatment if the results are positive. As for phase four, this is done after the treatment is approved and is essentially just meant to monitor how well the drug works on a larger and more diverse population for a longer period of time.
There Are Risks to Your Health and Treatment Progress
Getting involved in a clinical trial may look great on paper, but it’s important to note that there are some possible downsides to participating, such as potential worsening of the disease and the extensive amount of time a trial can take to complete.
“While there are many benefits of participating in a psoriasis clinical trial, patients should be aware of potential risks. For instance, there’s always a possibility that you may not receive any treatment at all and be given a placebo throughout your involvement in the study,” says Dr. Nelson, who adds that this is because most studies are randomized, which means patients are assigned to different groups by chance, and only one of the groups receives the actual medication. The most common method of randomization is simply flipping a coin to determine the outcome for each participant.
More importantly, Dr. Nelson says there’s also a risk of experiencing side effects or seeing no improvement, as well as worsening of your psoriasis. The drug may also cause long-term issues that become identified years after the trial is over. And finally: Being a clinical-trial volunteer can be time-consuming as you’re expected to follow up regularly with the study team. These are all important factors to consider, but you should also know, you’re not locked in if you feel the need to bow out. You can stop participating in a trial at any time, so if it ends up being a negative experience, you have an easy out. “Clinical trials are completely voluntary, so if you decide to end your participation for any reason, you will not be penalized,” says. Dr. Nelson.
You Could Earn Cash and Free Medical Care
Another potential benefit to participating in a clinical trial for psoriasis is that volunteers are paid—in some form at least—for their time and involvement. “Compensation can range from $50 to a couple of hundred dollars, and it usually varies on the number of visits or type of monitoring or procedures required,” says Dr. Gonzalez. Payment is an incentive to encourage participants to join a trial and to stay until its completion. It also compensates them for their loss of daily wages and any clinical trial-related procedure or injury.
Dr. Nelson says most trials will also reimburse their participants for their time and travel expenses. “This can be paid after each visit or after your completion in the study,” she explains. “Volunteers also have the opportunity to receive free psoriasis treatment, lab work and tests, and clinical appointments by a dermatologist or another physician, so these factors alone may entice patients to become involved.”
Women and People of Color Are Especially Needed
Diversity in clinical trials for psoriasis is sorely lacking—but it’s not just limited to psoriasis trials. “Historically, there has been a lack of gender and racial/ethnic diversity in clinical trials as a whole, including in skin conditions like psoriasis, eczema, and acne,” says Dr. Nelson.
“An overwhelming majority of subjects in phase 3 psoriasis clinical trials are Caucasian, leaving unanswered questions about how one’s ethnicity or race might impact the safety and efficacy of today’s psoriasis treatments,” acccording to a recently published article in Dermatology Times about the lack of people of color in psoriasis clinical trials.
When it comes down to it, Dr. Gonzales says, we need more diversity in psoriasis clinical trials in order to improve the data we have. “The minority population in the United States is outpacing the growth of the non-Hispanic white population, and this significant demographic shift creates a tremendous demand for racial diversity in the clinical trials,” she explains. “It is well known that ethnicity and race may play a role in response to biologics, and most trials so far mostly consist of White Caucasian groups.” That means some of the data collected from these trials will not be applicable to Hispanic and Black patients, who are usually the ones with less access to healthcare and advanced therapeutic options in the first place.
As it turns out, there are deep, systemic reasons for the lack of diversity in clinical trials. For one: Fear.
“Medical mistrust in U.S. clinical trials among marginalized groups stems in part from implications of the Tuskegee Syphilis Study, medical experimentation on prisoners, and medical evaluation of immigrants,” Dr. Nelson says.
Today though, Dr. Nelson says, there are rules in place to ensure that research is ethical and risks are minimal—that, and companies involved in research of skin conditions are now doing a better job at reporting race and age of participants in trials than they did in the past.
As of now though, a gap still exists. The majority of trial participants are white males. “Some ways to improve participation so that clinical trials represent the demographic of the general population include community education about clinical trials, especially in communities where a group may be underrepresented, partnering with patient-trusted organizations like the National Psoriasis Foundation, and physician advocacy,” says Dr. Nelson. “Ultimately, the more demographically diverse a clinical trial is, the more realistic the outcomes will be once the treatment has been approved.”
Dr. Gonzalez says there’s also little data available regarding the diversity of dermatology research with respect to gender. “A systematic review performed found that only 85 percent of the 626 randomized control trials reported the sex of the participants, meaning that approximately 15 percent of them are not reporting it all,” she explains. “One must keep in mind that in a few studies that have been done with proper stratification of study participants, females and younger patients are at higher risk of depression and bad quality of life, so this is a particularly susceptible group that we need to ensure are properly represented in clinical trials in order to better assist them.”
How Clinical Trials Work: The National Psoriasis Foundation. “Clinical Trials 101.” psoriasis.org/clinical-trials-101/
Medical Randomizing: Journal of Human Reproductive Sciences. (2011) “An Overview of Randomization Techniques: An Unbiased Assessment of Outcome in Clinical Research.” doi: 10.4103/0974-1208.82352
Medical Mistrust: Patient Education and Counseling. (2018) “A Systematic Review of Medical Mistrust Measures.” doi: 10.1016/j.pec.2018.05.007
Rules to Ensure Inclusion: National Institutes of Health. “Guiding Principles for Ethical Research.” nih.gov/health-information/nih-clinical-research-trials-you/guiding-principles-ethical-research
Diversity in Clinical Trials: JAMA Dermatology. (2017) “Diversity in Dermatology Clinical Trials: A Systematic Review.” doi:10.1001/jamadermatol.2016.4129
Improving Diversity in Clinical Trials: JAMA Dermatology. (2017) “Suggestions for Increasing Diversity in Clinical Trials.” doi:10.1001/jamadermatol.2017.0850
Finding a Clinical Trial: National Psoriasis Foundation. “Clinical Trials for Psoriasis: What You Need to Know.” psoriasis.org/clinical-trials/