Eczema affects more people in the United States than diabetes (10.1 vs. 9.4 million)1,2. More than 8 million Americans have psoriasis.3
Considering how common some skin conditions are, one would assume sponsors would have no trouble finding clinical trial participants.
Not necessarily. Although many dermatological conditions affect millions of people, dermatology clinical trials face similar patient recruitment challenges as other diseases and conditions.
Here, we take a look at a few of the top patient recruitment challenges dermatology trial sponsors face, as well as solutions to help encourage signups and ultimately boost those important enrollment numbers.
Patient awareness
Challenge: Many patients believe clinical trials benefit modern medicine, but they don’t know where to find them. A study published in JAMA last year surveyed more than 12,000 individuals about their clinical research perceptions. It found 84.5% perceived clinical research as important, but 59% couldn’t name a place that conducted clinical studies. Nearly 45% said their physicians rarely suggest clinical trials as a treatment or medication option.4
Solution: Patients have more ways than ever to research available clinical trials. In addition to ClinicalTrials.gov, patients can research CenterWatch, an easy-to-navigate information source for patients and professionals. Patients can also check advocacy group and disease-focused websites, and, in the case of melanoma, NCI and the American Cancer Society.
One of the only—if not the only—resource specifically for dermatology studies, Studies&Me links patients to doctors and clinics in their area to find relevant clinical studies. Patients fill out a questionnaire outlining their interest. A dermatologist evaluates the information and checks for relevant studies. If there’s a match, Studies&Me connects the patient with a doctor via telemedicine.
In a phase 3 trial to evaluate the efficacy and safety of tralokinumab monotherapy in patients with moderate to severe atopic dermatitis, researchers used Studies&Me as an add-on recruitment strategy. Results showed 1,500 patients signed up through the site, learning about the study through social media ads. Of those, 46 were considered eligible. Ultimately seven of those patients had a positive screening and participated in the trial. Using the online method, the recruitment time shortened by three weeks and the number of days used per site dropped from 65.5 to 21.4.5
Clinician awareness
Challenge: Most physicians feel comfortable with referring patients to clinical trials generally; however, they may not have enough information to confidently make those referrals. A dermatologist may receive a multipage protocol with the expectation she will read through and find the necessary information. In reality, it will sit there unread because the physician doesn’t have time to dig through pages of complex language.
Solution: Make it easy for dermatologists to refer patients to clinical trials. Include a protocol summary with the full protocol. Schedule an in-person visit or video call to discuss details. Give them brochures, flyers, and other literature they can pass along to patients.
Informed consent
Challenge: Informed consent is required before conducting any procedure. Without close communication between the patient and the principal investigator or another qualified professional, the patient may decline to enroll or drop out early. For the patient, there shouldn’t be any surprises around possible complications, risks, side effects, and/or responsibilities.
Solution: Take a patient-centric approach to informed consent. Make sure all documents are easy for a layperson to understand and clearly outline all important information, including benefits, risks, inconveniences, side effects, responsibilities, and what to expect during a procedure or appointment. If a patient understands that the potential benefit of a treatment may not appear for up to six weeks, he’ll be less likely to abandon the trial early because he doesn’t notice a change.
Biorasi likes to employ study navigators to enhance the communication process. A study navigator acts as a link between the patient and the site, answering all the patient’s questions about a clinical trial. If there’s a question the navigator can’t answer, she’ll direct the patient to someone who can. When patients have a “real person” to talk to about a trial’s requirements, risks, and benefits, we find their anxiety lessons and they’re more likely to enroll and stay enrolled.
The hassle factor
Challenge: The JAMA survey subjects perceived clinical trial participation as “inconvenient and burdensome.” Nearly half (49%) said clinical trial participation disrupted their daily routine.
Solution: Can we make the process less burdensome and disruptive? We think so. To ease patient burden, some dermatology clinical trials incorporate telemedicine services. Using remote monitoring, patients can report certain data points without having to drive to a hospital or clinic. Sponsors can also handle recruitment, informed consent, education and compliance issues using telemedicine or a web platform.
Whether it’s telemedicine or another approach, find ways to eliminate reasons patients miss appointments or don’t participate: lack of transportation, inability to take off work, and an inability to find childcare are a few. Consider arranging transportation, covering childcare costs, and, for participants who live far away, coordinating travel arrangements. The less patients have to worry about the more likely they’ll participate in your study.
Other patient-centric practices include priority scheduling for appointments, evening and weekend hours, and a protocol that includes fewer visits overall. Just like informed consent, clinical trial logistics should consider the patient first.
Access to patients
Challenge: Site selection is key to clinical trial success, starting with patient recruitment. A clinical site must have the patient population to support the trial. Certain institutions may not have the volume to support a rare disease clinical trial.
Solution: Thoroughly vet each site to ensure they can accommodate your trial. In the alternative, use fewer sites but be prepared to support patients traveling across the country or internationally.
To further boost patient recruitment, reach out to advocacy groups and medical networks. These resources can be huge assets in getting the word out about your trial. You may also find a patient advocate who can promote the study even more.
If you are recruiting for a rare dermatological condition, partner with a CRO that has extensive experience in rare diseases and small patient populations. Biorasi has access to sites worldwide to help sponsors recruit and enroll the patients needed for clinical trial success.
Planning a dermatology clinical trial? Speak with one of our dermatology experts.
Resources
- National Eczema Foundation. Eczema Facts webpage.
- Centers for Disease Control and Prevention. “New CDC Report: More than 100 million Americans have diabetes or prediabetes.” Press release, July 18, 2017.
- National Psoriasis Foundation. Statistics webpage.
- Anderson A, Borfitz D, Getz K. Global Public Attitudes About Clinical Research and Patient Experiences With Clinical Trials. JAMA Netw Open.2018;1(6):e182969. doi:10.1001/jamanetworkopen.2018.2969
- Katz, MD, et al. “Optimize clinical trial recruitment with digital platforms.” Dermatology Times, January 4, 2019.
