Decentralized and virtual clinical trials are gaining prominence, particularly since the COVID-19 pandemic which made it difficult for trial participants to attend in-person appointments. However, conducting clinical trials remotely has a host of potential benefits beyond reducing COVID-19 transmission, including improved patient compliance, real-world data, real-time data, and reduced costs. ObvioHealth is championing this approach to clinical trials, and through a partnership with Renovia, completed the first fully virtual clinical trial in urogynecology, which investigated the leva Pelvic Health System. The leva device is intended to treat female urinary incontinence, and the virtual trial allowed participants to upload data on their symptoms and progress right from their home. Another aspect of virtual trials is their potential to increase the inclusivity of clinical trials. Women are often underrepresented in clinical trials, in part because of busy lifestyles that lead to recruitment issues. Virtual trials can more easily fit in with other commitments, as they don’t require fixed appointments and allow trial subjects to fit the trial around their lives rather than vice-versa. Medgadget had the opportunity to speak with Ivan Jarry, ObvioHealth CEO, about virtual trials. Conn Hastings, Medgadget: Please give us an overview of virtual clinical trials and their history. Has this approach been in practice for long? Ivan Jarry, ObvioHealth: The first virtual clinical trial happened in 2011, and was conducted by Pfizer. Until recently though, virtual clinicals trials were more buzz than actual practice. When the pandemic hit in early 2020, almost 70% of traditional/on-site clinical trials on a global scale were disrupted or stopped altogether. Since then, the implementation of decentralized clinical trials has accelerated in a dramatic way. An industry initially resistant to change was jolted into recognition of the many benefits of virtualizing clinical trials. This year, decentralized trials will increase by 28% from 2021, which marks a 93% boost from 2020. ObvioHealth certainly has a place in DCT history. Long before the pandemic, we knew innovation was needed in the clinical research industry, so in 2017 we launched one of the first-ever patient apps for conducting clinical trials at home. Medgadget: Please speak to the importance of patient compliance in clinical trials. How do virtual trials help to enhance patient compliance? Ivan Jarry: Compliance helps power a clinical study. If patients don’t comply, the study data loses integrity. If too many patients fall out of compliance, there won’t be sufficient data to prove efficacy. That equals a lot of wasted time and money for clinical trial sponsors. In a decentralized clinical trial, compliance is often much easier. DCTs reduce the patient burden by allowing them to complete study tasks from home without the need for site visits. Despite the virtual nature of DCTs, patients still require human interaction. ObvioHealth’s COACH (Clinical Oversight and Coordination Hub) team engages with patients through live chat, text, email or phone. This team answers patient questions, helps troubleshoot tech issues and ensures patients are comfortable with the study tasks. If a COACH team member notices a patient who has not completed certain study tasks, the team member can reach out to understand why and encourage the participant to get back on track. Medgadget: How do virtual trials compare with conventional trials? What are the advantages of the virtual approach? Ivan Jarry: A traditional trial requires patients to visit clinics for medical assessments and, often to fill out trial diaries on paper. A virtual, or decentralized, clinical trial removes many or all of those clinic visits and captures data from patients as they go about their daily lives—from the comforts of home. This makes the clinical trial journey much easier for patients, reducing the burden of travel, and thus, as stated above, increasing compliance. But there are many other benefits of collecting data from patients at home, as opposed to inside a clinic. The data from home is more real world, removing any effects from white-coat syndrome. The data is also more real time. Instead of waiting for a site visit to tell a clinician how a patient is feeling, he/she can put the data in the app as symptoms occur. The advent of new digital devices and instruments is now providing a growing number of opportunities to integrate technology into decentralized studies in ways that were previously impossible. These devices can capture vitals, symptoms and other signals from the comfort of home, improving outcome accuracy. They are also opening up the possibility for new endpoints to progress research. ObvioHealth is currently working with partners to develop digital instruments that are capturing real coughing, crying, breathing events as well as skin images and uploading them through our app. Previously, the only option was to rely on patient reporting or oblige them to go to a site to be ‘assessed’. Medgadget: What inspired you to establish ObvioHealth? Ivan Jarry: Traditional clinical trials are slow, expensive and often fail to reach completion. I co-founded ObvioHealth in 2017 to leverage technology as a way to address these inefficiencies with the goal of providing a seamless trial experience for the patient. The founding of the company pre-dated the pandemic because we saw how the digital frontier was changing healthcare and we saw the need for a similar transformation in clinical research. We knew that with patients’ consent, we could tap into a wealth of resources and data through their smartphones, using these as an effective tool to rethink the way we do research. The result has been trials that are faster, easier and more accurate. Medgadget: Please give us an overview of your recent trial of Renovia’s leva Pelvic Health System. Ivan Jarry: Through our partnership with Renovia, we conducted the first ever fully virtual clinical trial in urogynecology. We knew a decentralized study design could overcome barriers on an often “taboo” subject: incontinence in women. Incontinence affects 62% of adult women in the U.S. This groundbreaking study tested the efficacy of an at-home medical device against a control group. The women in the study used the device and recorded each time they went to the bathroom or had a leak in the ObvioHealth app. Among the many study achievements were high compliance- even among an older patient population – and lower costs. Medgadget: Do you think that decentralized and virtual trials will help to increase the representation of women’s health issues in clinical trials? Ivan Jarry: With the exception of breast cancer research, women’s health issues are unfortunately under-represented in clinical trials. Women are busy, and just like we saw during the height of the pandemic, they often juggle careers, motherhood, finances, etc., leaving little time for their own health and wellness. But this is no excuse for the industry to ignore this cohort. As we turn toward a more virtual future, decentralized clinical trials can provide trial access to women in an easier way to capture this crucial data. Hopefully, this will encourage trial sponsors to commit to more research on women’s issues – such as incontinence, fertility, maternal health, menopause, endometriosis and many other issues. We have already successfully completed several decentralized trials in women’s health, and we’re quite proud to be a part of such important research. Source
