Enter decentralized clinical trials (DCTs).
In ObvioHealth’s experience conducting women’s health studies, we’ve found that decentralization and strategic study design provide an effective avenue for overcoming common barriers in women’s health research.
Read on to explore how we used decentralized modules to improve recruitment, engagement, retention, and data accuracy in a recent women’s health study: The first fully virtual clinical trial conducted in the urogynecology space, designed to test the efficacy of Renovia, Inc.’s leva® digital therapeutic.
For participants in general, clinical trials can be time-consuming and burdensome. They also provide no guaranteed positive outcomes. These challenges—in addition to women’s tendency to prioritize the health of others—disproportionately deter women from participating, according to a literature review conducted by the National Institutes of Health’s Office of Research on Women’s Health. Difficulties with recruiting women overall then translate into difficulties recruiting a representative and diverse population of qualified female participants.
But, the challenges don’t stop there. According to Robin Sutherland, Renovia’s Vice President of Human Resources and Clinical Operations, the onset of the COVID-19 pandemic presented additional barriers to recruiting this cohort.
“While urinary incontinence will hit about 50% of women, it especially starts to hit over the age of 50, and we knew those women were going to be more conversative about taking care of themselves during COVID,” Sutherland shared in a SCOPE Summit 2022 session, DCTs & Devices: Lessons Learned From a Women's Health Med Device Trial.
ObvioHealth responded to these hurdles with a strategic study design: A fully virtual clinical trial. This fully virtual design allowed for the enrollment of participants who would otherwise be unwilling or unable to travel to clinical sites, especially during a pandemic. The deployment of a digital recruitment campaign using social media targeting and digital advertising assets also enabled faster and more inclusive recruitment. 350 patients were enrolled in the study in just fourteen weeks; of those participants, 22% were women aged 65 or older, and 20% identified as Black, First Nations, or Hispanic
Our virtual site team—the Clinical Oversight and Coordination Hub (COACH) team—was also readily accessible to patients throughout the trial, from pre-screening through to the study’s conclusion. The COACH team’s reliable support resulted in a retention rate of 89%.
Despite efforts to overcome the stigmas associated with women’s health concerns, the fact remains that many women still feel uncomfortable discussing intimate health topics both inside and outside a clinical environment.
This is especially true for women experiencing urinary incontinence. (A 2011 study found that urinary incontinence leads to more shame and embarrassment than cancer or even depression.)
The trial for the leva® device required participants in the experimental group to insert a probe vaginally. ObvioHealth’s COACH team also instructed the control group in a series of pelvic floor exercises, the current standard of care for urinary incontinence. Because of the virtual nature of the Renovia trial, participants were able to do this in the comfort of their own homes. Training was performed via phone call as opposed to video call to allow for more privacy and discretion.
When participants are required to track symptoms such as incontinence or hot flashes, which can occur frequently throughout the day, accurately reporting the duration or frequency of these events can be a challenge. This is particularly true for busy women, Renovia’s target population for its urinary incontinence study.
ObvioHealth’s solution was to collect data in real time, using a simple electronic patient-reported outcomes (ePRO) process. Using a smartphone app, participants reported their trips to the bathroom and episodes of incontinence with the simple touch of a button. To ensure participant compliance, internal programming notified ObvioHealth’s COACH team when a patients’s symptom reporting faltered. A member of the COACH team would then reach out to the participant, addressing any concerns and steering them back to accurate and timely reporting.
Clinical trials in women’s health can pose significant challenges to teams and sponsors alike, including recruitment, retention, and patient-reported data collection. However, sponsors can partner with an experienced CRO to address these challenges through effective DCT study design and implementation. As evidenced in our work with Renovia, we partner with sponsors to develop tailor-made DCTs that facilitate enrollment, participant comfort, and accurate data collection--driving improved quality, engagement, compliance, and outcomes.