A decentralized clinical trial is one where technology is used to communicate with study participants and collect data. This can take many forms, from electronic patient-reporting (ePRO) to remote monitoring or telehealth visits. Other terms often used interchangeably with DCT are virtual or remote clinical trials.
Decentralized clinical trials have significant benefits for both patients and sponsors. For patients, DCTs make the trial more convenient, reducing the burden to participate. The ObvioHealth app on a participant’s personal smartphone is almost always on hand so they can report from the comfort of their homes or, if a medical assessment is needed, a telehealth or home visit can be organized. Labs or imaging can be conducted locally rather than having to travel to sites. The elimination of geographic boundaries also makes trials accessible to a broader swath of the population. For sponsors, easier recruitment leads to more cost and time-efficient trials. The ability to recruit without boundaries improves the reach and diversity of cohort populations. Additionally, because trials are easier for participants, compliance and retention rates for DCTs are typically much higher than for site-based studies. The ability for participants to report remotely and in real-time delivers more accurate and robust data. Sponsors can visualize this data more readily and make strategic decisions more rapidly.
A fully decentralized clinical trial enables participation without having to visit sites; study participants can do the entire clinical trial from their homes. They can give electronic informed consent, have their study product shipped to them directly, report via their app, and use devices to capture vitals remotely. If they need to submit samples, these can be collected at a conveniently located laboratory or via a home healthcare provider. In some cases, participants can collect their own samples via DIY kits. Hybrid DCTs include elements of both a traditional clinical trial, with visits to a central investigational site and a DCT, where data is collected remotely.
In a decentralized clinical trial, site responsibilities are typically centralized around a remote team, or they can also be shared with traditional sites when the study is hybrid. In the case of ObvioHealth, the COACH (Clinical Oversight And Coordination Hub) performs many of the same functions as a traditional site but does so remotely. This can include meeting with patients, walking them through consent, answering questions, training them, and reviewing their reports. When a traditional site visit is necessary for a specific procedure, the responsibility for patient oversight may flow back to the site for the time of the visit.
Components of decentralized clinical trials can be used for studies in just about any therapeutic area where patients are not hospital-bound. ObvioHealth is currently conducting DCTs in 17 different therapeutic areas. Day-to-day diary completion and reporting is easier for patients on an app. Products and devices can be shipped to homes and training can often be done virtually. The degree to which a study can be fully decentralized will depend on the protocol and the need for on-site visits.
The ability to go remote depends on the study objectives, the corresponding requirements of patients, and the outcomes that you're expecting to get from the study. We work very closely with sponsors to design the best solution for their needs. Most studies can implement at least components of the virtual model, which help reduce patient burden and facilitate remote data management and monitoring. Studies that require face-to-face medical oversight or intervention will not be fully virtual, but can still employ decentralized elements to minimize on-site activities.
DCTs can be utilized for all phases of the study. To date, they have most often been used for Phase II and III studies. ObvioHealth has experience across the globe in late Phase I, early Phase II, Phase III, and post-market and medical marketing-type studies where we're asking participants specific questions around consumption and efficacy of a product.
A decentralized clinical trial model involves the use of the same rigorous process, standards, and guidance by the FDA as a traditional site-based clinical trial, including standards for electronic data capture and ePRO collection. ObvioHealth clinical scientists have considerable expertise in supporting successful clinical trials and trial efficacy and safety outcomes across all therapeutic areas and ensuring clinical strategic paths will meet with the approval of the FDA, EMA, and other global regulatory authorities.
The best decentralized clinical trial technology is designed to be simple to use. Patients of all ages have been able to manage ObvioHealth's technology with ease. The training videos are very clear and the participants are able to ask the COACH (Clinical Oversight And Coordination Hub) team any outstanding questions through phone, email, and chat. We are frequently asked whether older participants can use the technology. ObvioHealth conducted an analysis following a recent COVID-19 registry study confirming that older patients are as compliant as their younger counterparts. The study required participants to report symptoms and disease status daily using the ObvioHealth app. 804 participants were enrolled, with ~10% providing end-of-study feedback. The 45% of respondents aged 50 to 74 years old reported that the electronic diary was very easy to use and manage, with ratings equivalent to the younger population. ObvioHealth also runs many pediatric studies and is familiar with designing protocols to make compliance easier for caregivers/parents.
ObvioHealth is all three. We are a virtual research organization leading the virtual clinical trial revolution. As a boutique CRO, we have been running decentralized trials end-to-end for biotech, consumer health, and digital device innovators since 2017. We built our proprietary app and platform to make virtual clinical trials safer, easier, faster, and better at generating the data needed to support health innovation. But, we aren't just software developers. We have our own experienced clinical team, including study coordinators who work centrally and virtually to coordinate every step of the trial. They act as a virtual site.
ObvioHealth's decentralized clinical trial platform is designed end to end as a unified data repository for virtual or hybrid research. When designing the platform, we set about modernizing each step of the trial process, from onboarding to logistics, to outcomes measurement and reporting. At each step along the way, we identified the impediments to efficiency. We also knew that even great software would be insufficient to deliver successful studies. So, rather than focus solely on the tech, we designed our tools to be run by our in-house COACH (Clinical Oversight And Coordination Hub) team, putting them at the center of our virtual system. The results are a platform and team that is both patient and sponsor-friendly.
ObvioHealth's products include our virtual clinical trial platform and BYOD app. Within this, we are able to offer targeted digital recruitment services, RWD mining for study design optimization, eConsent, participant, site, and expert rater training, provider assisted recruitment and enrollment, study product and device shipment and tracking, ePRO (including audio and image capture), remote patient monitoring, eClinRo, data analysis, visualization, and reporting.
ObvioHealth has worked across 17 therapeutic areas covering pharmaceuticals, medical devices, and nutrition. These include: cardiology, oncology, respiratory, men's and women's health, dermatology, GI, hepatology, mental health, oral health, and infectious disease (COVID-19).
ObvioHealth has been global from the outset. Countries where we run trials include Australia, Bangladesh, Canada, Colombia, Czech Republic, Dominican Republic, Estonia, Finland, France, Hungary, Indonesia, Italy, Latvia, Malaysia, Mexico, New Zealand, Norway, Peru, Philippines, Romania, Russia, Singapore, Spain, Sweden, Thailand, and the United States.
Sponsors are recognizing that decentralized clinical trials, when planned and conducted properly, can deliver better data than traditional site-based trials. Rather than having an overburdened participant who reluctantly completes the study requirement at the last minute before a site visit, you have someone who remains engaged and is more likely to stick to the protocol. Activities like vitals measurement that have historically been performed on-site, can often be adapted to fit a decentralized study design with device integration for continuous monitoring and next-generation ePRO where all data flows into a single study dashboard for seamless real-time review. ObvioHealth's capabilities also enable the detection of novel outcomes and biomarkers using unique instrumentation that leverages remote patient monitoring, images, audio, and video in combination with AI and machine learning.
Since patients can participate from the comfort of their homes, they are less burdened than in trials where they need to travel, sometimes long distances to a site. ePRO from a user-friendly app makes reporting easier and faster. In cases where patients do forget to report, a programmed reminder notifies them. If they still aren't compliant, our COACH (Clinical Oversight And Coordination Hub) Team will reach out to see what the issue may be. This team is available at all times to answer questions and establishes a good rapport with patients. As a result, our average compliance and retention figures hover at around 90%.