Safety, High-Level Details Among Deciding Factors for AD Trial Participation

Patients and families of patients with atopic dermatitis (AD) use several factors to determine whether they or their child will participate in clinical trials for their condition, including perceived risk and overall safety, method of drug administration, and more.

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The National Eczema Association (NEA) announced the information in a press release,¹ noting that this is the first published information resulting from its ongoing research into clinical trial awareness, decision-making, and preferences among patients with AD and/or their caregivers. This research has been published in Contemporary Clinical Trials Communications.

Using a survey,² researchers from the NEA sought to investigate the clinical trial preferences of patients with AD and their parents, citing the significance of rigorous clinical trials in determining the safety and efficacy of eczema therapies. Most specifically, they investigated the factors most frequently considered when an adult patient or caregiver is deciding to enroll in a clinical trial.

The survey was 46 questions long and was open for completion from May 1 to June 6, 2020. Each question required participants to rate the subjective importance of determining factors on a scale of not important at all/of little importance to medium importance and high importance. These factors included general, therapy, financial, convenience, social, and personal factors.

General Factors

• Having in-depth details on the purpose of the clinical trial and test drug
• Having trust in the clinical trial doctor(s)/site
• Understanding when/how can still work with current doctor
• Route of therapy administration
• Transparency

Therapy Factors

• Potential side effects of the test drug
• Washout period
• Potential to receive better eczema care than currently receiving
• Possibility of receiving a placebo
• Having rescue therapy option 
• Potential access to study test drug at completion of trial

Financial Factors

• Coverage/acceptance of clinical trial by current insurance if not covered by the trial
• Potential financial impacts
• Ability to be compensated or reimbursed for participation

Convenience Factors

• Distance of clinical trial site to my home
• Duration/length of the trial
• Number of required study visits, procedures, or follow-up items
• Ability to complete some study requirements from home instead of in the clinic
• Ease/difficulty in learning and sticking with the trial treatment regimen
• Overall fit with work/life schedule

Social Factors

• Approval from family or friends to participate in a trial
• Having a supportive community outside the clinical trial
• Trusted doctor’s recommendation to participate
• Any doctor’s recommendation to participate
• Knowing that one would contribute to research that will ultimately help find better treatment for themselves and others who suffer from eczema

Personal Factors

• Overall fit with career/school trajectory
• Trial impact on family planning/pregnancy
• Overall fit with family obligations
• Potential impact on overall health
• Level of satisfaction with current treatment approaches
• Having support from the clinical trials site to help navigate the process and manage all the “moving parts”

Furthermore, researchers gathered several demographic data points for each participant, including age, gender, race, and ethnicity. Additionally, they collected survey-specific data, including respondents’ rating of a general understanding of how clinical trials are conducted and eczema severity.

In total, 1016 participants responded to the survey, but researchers were only able to analyze 604 responses, 77.8% of which were from adult patients and 22.2% of which were from caregivers. This was due to a number of participants (n=412) who did not indicate previous clinical trial experience or had not previously considered participating in a clinical trial.

Caregivers, on average, ranked “having in-depth details on the purpose of the clinical trial and test drug” as the single most important deciding factor. Adult patients with eczema ranked “having trust in the clinical trial doctor(s)/site” as the most important deciding factor for clinical trial participation.

“This study suggests the factors eczema patients and caregivers consider most and least important when considering CTP [clinical trial participation] are largely the same. Caregivers, however, are more likely to attribute higher importance to factors that may affect the well-being of their child, such as the impact on overall health, possibility of a washout period, or the option to have a rescue therapy,” study authors wrote. “Only altruism is rated more highly by adults than caregivers...These findings play a critical role in understanding the reasons why adult eczema patients and caregivers of children with eczema do or do not participate in clinical trials and the factors that are most important to them when considering CTP.”

References

1. Association NE. New research reveals most critical factors for eczema patients in considering a clinical trial. PR Newswire: press release distribution, targeting, monitoring and marketing. May 11, 2023. Accessed May 12, 2023. https://www.prnewswire.com/news-releases/new-research-reveals-most-critical-factors-for-eczema-patients-in-considering-a-clinical-trial-301822038.html.
2. Johnson JK, Loiselle A, Thibau IJ, Smith Begolka W. Factors related to eczema clinical trial participation among adult patients and caregivers. Contemp Clin Trials Commun. 2023;33:101138. doi:10.1016/j.conctc.2023.101138