Decentralized clinical trials (DCTs) offer an effective avenue for studying what are sometimes considered “taboo” therapeutic areas (those that involve highly personal or sensitive medical areas) while respecting participants’ preference for discretion and generating meaningful outcomes. ObvioHealth has conducted multiple trials on taboo topics, providing helpful insights and best practices to maximize participant recruitment and engagement and enrollment and onboarding for decentralized research.
It’s important to note that taboo medical conditions aren’t innately shameful. But patients who internalize negative cultural attitudes may hold back from talking openly about their symptoms, which can fuel misconceptions and perpetuate stigmas.
“Coming from a clinical background, we think talking about these issues is normal, but a lot of people don’t,” ObvioHealth director of clinical operations Joshua Lowndes notes. “Some issues are harder to talk about, even with a medical professional. You might feel this person is judging you. These concerns can make someone feel reluctant to join a clinical trial.”
Numerous studies show how inhibition around taboo topics impacts the patient experience well-being:
· Women’s health: British researchers found that some women attribute urinary tract infection to personal weakness, such as poor cleanliness, and that these women “might be particularly vulnerable to feelings of not being taken seriously by their doctors.”
· Urology and men’s health: “Due to stereotypical perceptions of masculinity, men are often hesitant to visit health care providers,” according to research published in the WorldJournal of Men’s Health. Meanwhile, urologists function as an access point for men to seek medical care. With that in mind, clinical research and therapeutic development for men’s health conditions may improve overall healthcare delivery.
· Mental health: Sociologist Erwin Goffman lamented in 1963: “There is no country, society or culture where people with mental illness have the same societal value as people without a mental illness.” Fortunately, acceptance of mental health support and intervention has increased dramatically. But stigma still remains. Clinical research can address this stigma resistance, which is linked with better psychiatric and psychosocial outcomes.
· Gastrointestinal health: According to a column in The Lancet, “Stigma around irritable bowel syndrome is prevalent among the general public, health-care professionals, and co-workers, and is often related to poor understanding of the condition.” Stigma is linked with “unsatisfactory outcomes” for IBS patients, “including increased health-care use, psychological distress, and impaired quality of life.”
Researchers in the Journal of Science Communication note several factors, such as “medical uncertainty, complex jargon, and patients’ misunderstanding of the human anatomy,” that exacerbate taboos and limit a patient’s ability to participate in shared decision-making.
When studying taboo topics, DCTs offer several advantages for sponsors and clinical research organizations (CROs).
Recruiting participants for research on sensitive topics can be challenging because prospects may be reluctant to discuss these conditions explicitly. Digital ad campaigns offer an efficient recruitment pipeline to bypass these hesitations and enroll participants.
Social media and search engine ads allow motivated prospects to find relevant studies that may be a fit. When prospects go online to look for answers about a medical condition affecting them or a loved one, these campaigns direct them to clinical trials relevant to their intent.
Importantly, virtual clinical trials don’t require in-person enrollment, which:
· Shortens the window of time for prospects to second-guess themselves, increasing the likelihood of enrollment.
· Allows prospects to remain relatively anonymous, offering a sense of privacy.
· Can strengthen the participant pool by expanding access for people with conditions that limit their ability to travel.
Sponsors and clinical research organizations need to understand cultural and participant attitudes around taboo topics to appropriately define and target the study population. These insights will help to develop more successful patient recruitment campaigns and can also inform the product’s regulatory submission and go-to-market strategy.
“In digital recruitment, we use patient-centric messaging that retains clinical integrity, so participants can understand for themselves whether this study is right for them,” ObvioHealth director of clinical operations Joshua Lowndes says. “Research teams should translate advanced clinical terms into language laypeople can understand.”
For instance, ObvioHealth was commissioned to assess the efficacy of an FDA-approved Class II medical device compared to standard exercises to treat stress urinary incontinence and stress-predominant mixed urinary incontinence in women. When recruiting for this study, researchers needed to describe “vaginal prolapse” in a more participant-friendly way.
After participants enroll, maintaining engagement and compliance is key—and this is where DCTs offer another advantage. Talking about symptoms face-to-face can make participants feel overly exposed, which can drive high dropout rates in traditional, site-based trials. But virtual study participants complete study tasks from the privacy and comfort of their homes.
DCTs create a safe space between participants and researchers, so people feel more at ease discussing symptoms and changes in their health. “Virtual trials give us just the right amount of human connection, because we’re engaging virtually without seeing each other physically,” ObvioHealth medical director Dr. Parth Shah says. “This creates an environment where participants feel less vulnerable and more in control of their experience.”
Research teams can also get more precise, granular information from electronic patient-reported outcomes (ePRO). This is because participants can complete ePRO in real time rather than waiting for an in-person appointment, and they can report sensitive symptoms in a more discreet setting compared with a physical interview.
The ongoing development of artificial intelligence also allows study teams to use machine learning to discreetly capture and interpret new sources of data. For instance, participants could take and save images of stool samples within a study app, rather than storing images to their camera rolls.
However, virtual trial participants should still be able to get support when they need or want it. ObvioHealth’s virtual study team, known as the Clinical Oversight and Coordination Hub (COACH), engages participants with phone calls, texting and an online chat feature.
Constant access to the COACH team provides participants the encouragement they need to remain engaged, and regular notifications help them remain compliant with the study protocol. The beauty of a virtual trial is that participants can complete study tasks and engage with the research team in the ways that best support their needs and wishes.
Best practices for DCT participant engagement: Virtual study teams should offer ongoing support tailored to participants’ needs and comfort levels. “Being patient-centric in a virtual trial means that we listen to how participants describe changes in their symptoms, and we take our cues from the types of words they prefer,” ObvioHealth medical director Parth Shah says.
Recruiting and prescreening decentralized research on “taboo” topics deserves more investment because new therapies for “taboo” health conditions offer life-changing potential. By breaking down traditional barriers to research, virtual trials help sponsors bring these vital products to market, maximizing their impact for patients.