Mention the words “clinical trial” and some people may immediately think that participating in one isn’t worth their time.
But Dr. L. Eugene Arnold, professor emeritus of psychiatry and behavioral health at the Nisonger Center at Ohio State University’s Wexner Medical Center, encourages people to think otherwise. He says that participating in one can assist others, including those with attention deficit hyperactivity disorder. “Everybody benefits,” he says. “You’re helping yourself and everyone else with the same problem. There’s a certain sense of satisfaction of being helpful to other people.”
Arnold, who is currently the principal investigator with a clinical trial focusing on neurofeedback, adds that people should also put concerns about wasting time by the wayside. While he says some trials, especially those involving medication, may require more frequent visits to the study location, such frequency often translates to more care, attention and detailed assessments.
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The Benefits
Janette Patterson, a marriage and family therapist in Silver Spring, Maryland, says that detailed assessments, regardless of the frequency with which a person is involved in a clinical trial, are always a good reason to participate. Not only do individuals obtain insight about their condition, but she says there’s also a significant cost-benefit. Usually, most clinical trials are either free or have a minimal charge, Patterson notes. “If someone did this in the private sector,” she says, “the results of a psychoeducational evaluation, for example, could cost a few thousand dollars.” A psychoeducational evaluation, she explains, helps parents figure out academic struggles of their child; armed with the evaluation, they can ultimately become more of an advocate for their child in the school system.
Through clinical trials, “researchers can document findings and get more insight about how ADHD impacts an individual,” says Patterson, who’s currently involved in one, collaborating with a University of Maryland professor about how ADHD may impact other family members.
Whether for ADHD or other conditions, Arnold explains that ongoing clinical trials are necessary in order to “improve on the current state-of-the-art” treatments in place. “New treatments need to be investigated and researched before they’re widely disseminated,” he says, adding that this is especially the case with medication, but it’s also important for behavioral treatments.
“There are numerous benefits to participating in clinical trials,” adds Ken Getz, founder and board chair at the Center for Information and Study on Clinical Research Participation, a nonprofit group dedicated to educating patients and their families about the clinical research process. “In interviews and studies that CISCRP has conducted among patients and their families, there are a number of top benefits: to gain access to new treatments that are not yet available through pharmacies, to gain access to and receive attention from medical experts and clinical trial staff, and to help others in the future by advancing knowledge about a given disease and how to treat it,” he explains.
… And the Cons
At the same time, Getz warns of the potential downsides of clinical trial participation. “Drugs in clinical trials are experimental treatments that may cause side effects, including serious adverse events and even death,” he says. “Some patients are also concerned that their condition will worsen during the clinical trial if they are given a placebo, which is an inactive drug, or another medication that doesn’t work, instead of the study drug.” Getz says that knowing the pros and cons of a clinical trial can help patients and their families “weigh the benefits and the risks” and move forward accordingly.
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Ensuring an Ethical Process
When a new medication or other treatment method is being evaluated through a clinical trial, the process is extremely detailed, Arnold says. He outlines an elaborate series of methods that leaves no stone unturned, including — but not limited to — data analysis, evaluation of that data by a biostatistician, comparisons of real treatment with the placebo and analysis of possible long-term benefits. Several people are involved in ensuring a seamless clinical trial, such as coordinators, data management teams and biostatisticians. “There’s a lot of thought and effort that goes into it,” Arnold says.
All of this, he notes, abides by a guiding set of ethical principles in which all research goes through a review committee to ensure that fairness and safety of the clinical trial remains intact. Additionally, he says that the person conducting a trial or study has to take annual refresher classes on topics such as ethics and fairness.
Participant Satisfaction
But in the end, will participants be inclined to join another clinical trial or suggest to friends or family that they consider one?
It would appear likely, as participants often report high levels of satisfaction about their clinical trial experience. “Studies in literature consistently show that the vast majority — 88 to 90 percent — of patients who participate in clinical trials would be willing to participate again,” Getz says. “This speaks to the perceived value of the experience and the relationship that patients establish with the clinical trial team.”
For example, a satisfaction survey of a Treatment of Severe Childhood Aggression study published in the 2015 Journal of Child and Adolescent Psychopharmacology, which focused on kids with “severe physical aggression, disruptive behavior disorder and attention-deficit/hyperactivity disorder,” received high ratings overall. For example, when parents were asked if they would recommend the study to parents with children who have similar problems, 98 percent said they would. “The majority of participants were not only highly satisfied with the experience, but also indicated that they would enroll again if offered the choice,” the article notes. “This exemplifies both the willingness of families to engage in pediatric psychopharmacological research and their ability to comply with the rigors of such studies.”
[See: 8 Things You Didn’t Know About Counseling.]
Lists of Clinical Trials
If you’re interested in learning more for yourself or your child, Patterson suggests reviewing the National Institute of Mental Health’s comprehensive list of studies. There are several involving ADHD and children as well as ones for adults experiencing a variety of disorders. She also suggests looking into the clinical trials conducted at the University of Maryland Medical Center.
Another resource is ClinicalTrials.gov, where there are several ADHD studies that can be filtered based on your preferences.
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Should You Participate in an ADHD Clinical Trial? originally appeared on usnews.com
