Virtual clinical trials (VCTs) are safer, easier, faster and better at generating the data needed to support innovation. They are a positive disruption to the clinical trial industry and, more broadly, to health innovation overall.
ObvioHealth delivers better data by deploying an easier digital clinical trial process that consistently achieves faster recruitment, higher compliance and fewer dropouts. We find new pools of participants more quickly and cost effectively, we make it both easier and safer for them to participate from the comfort of their homes and we keep them more engaged throughout out trials. When patients are engaged, they are more likely to adhere to your protocol—whether it is reporting events, using digital health devices, or taking medication.
And that means you get data that is more real time and real world and more complete. Better all around.
Our virtual trials complete recruitment up to 4x faster because our precision targeting taps into participants who would otherwise be unsolicited.
We average 48% higher medication adherence due to a combination of technology and our team that offers personalized support when needed.
Our trials deliver 60% fewer dropouts because we make the clinical trial journey easier for participants, allowing them to participate from the comfort of their homes.
Blood pressure data is a good example of how outcomes might differ depending on where the measurement occurs. White coat hypertension can cause blood pressure to increase in a clinic, causing higher readings than what a patient might experience at home. For trial sponsors looking to understand how patients react to and interact with their product, it’s best to test the product in the real world. This provides sponsors with data representative of how the product will be used once it's on the market.
Most sponsors/companies are familiar with the example of participants filling in their questionnaires in the car on the way to a site appointment. Virtual data capture is easier and faster for participants. Improved UX can make it as easy as tapping a mobile phone screen each time they experience symptoms or take their medicine. Reminders and notifications can nudge them so that they don’t wait too long before completing a task. And we are increasingly integrating devices that can, with participant approval, passively and constantly measure certain vitals.
Many people are also unaware of the trials that might suit them. By reaching out to people who would otherwise not be solicited, ObvioHealth gives access to virtual clinical trials for people living too far from a lab or clinic, or those who aren’t registered in a patient catalog but may be suffering silently with a disease. Given the chronic problem with under-representation of minorities and specific demographics in trials, virtual clinical trial recruitment is an important step to breaking down these barriers.
Sponsors are beginning to realize the benefits of conducting clinical trials in a patient’s home. Any trial can be virtualized. Although some site visits may still be required, virtual clinical trial solutions offer a modern approach to drug development without a drop-off in data quantity or quality. Activities typically performed on-site (i.e., dosing, vitals measurement) can be transitioned to fit a decentralized study design with components like device integration for continuous monitoring, next-gen ePRO, televisits, etc.
All data flows into a single study dashboard for seamless real-time review. Virtual clinical trial solutions make the difference between an overburdened participant who reluctantly completes the study requirement and one who remains engaged and sticks to the protocol. The higher the compliance rates, the more complete the data will be for sponsors. See below how ObvioHealth engages its patient populations to encourage compliance throughout the patient journey:
Seamless Recruitment & Enrollment
On-site clinical trials face many challenges during recruitment. ObvioHealth uses digital recruitment to bring virtual clinical trials online (aka mobile clinical trials). This method allows our team to target potential subjects as they scroll social media or navigate a search engine, instead of relying on doctors to identify and recommend potential participants. After recruitment, an electronic informed consent document(eIC) allows participants to review protocol and consent at their own pace, while study staff is available via phone or text to answer questions. Once eIC is signed, the participant is enrolled, and study materials are shipped to his or her home.
Easy to Complete Study Activities
ePROs (diaries, consumer perceptions, etc.) –In ObvioHealth’s virtual trials, ePRO data is collected directly from patients using a clinical trial app on their smartphones. Almost everyone has a smartphone on them, so patient diaries and validated questionnaires can easily be completed through the app from anywhere, as long as they can retrieve a cell or WIFI signal. ObvioHealth’s experienced clinical operations team and savvy tech team work in tandem to design user-friendly questionnaires, diaries and other tools to facilitate reporting. We use scales and pictograms whenever possible to make it easy for patients to tell us how they’re feeling.
Image/Audio Capture and Device Integration
Image , audio and video capture - The technology reinforces the accuracy of patient reporting by eliminating the bias that often creeps into self-reporting. For instance, an ObvioHealth study asked parents to capture and submit photos of their infants’ stools, instead of relying on them to score the stool consistency and color. Analysis revealed that parents were more likely to score their baby’s stools in the ‘normal’ range whereas the images, scored by experts (and increasingly through AI) told a more accurate story.
A separate study employed an audio capture device to record instances of crying among infants. Mothers in that study were asked to record the same events manually. A comparison of both data collection methods showed disparities between patient and device reporting, with tired parents recording crying times that were up to 4x longer than those recorded directly.
Device Integration - Implementing wearables or digital devices into a virtual trial facilitates passive data collection without disturbing the patient’s daily routine. By removing the need for patients to input data manually, we reduce the risk of data entry error, while making participation more convenient for trial subjects.
Study Team Engagement Prompts
Prompts: Reminders and notifications about study activities are sent to participant smartphones to increase protocol compliance, helping them stay on track.
Study team access: Should a question (or concern)arise, participants have constant access to a member of the study team via a messaging function housed within the app.
To learn more about our study design for virtual clinical trials, fill out the form below and our clinical operations team will contact you.
Case Study: Testing Efficacy & Gauging Consumer Perception of a Prebiotic Ingredient
• 400 participants in 28 days
• 90% protocol compliance
• Less than 10% of the planned budget was spent during recruitment
A Fortune 500 Multinational Packaged Food Company sought to launch an inulin product line under its fiber snack bar brand and wanted to leverage ObvioHealth’s virtual clinical trial solutions to test for efficacy and like-ability.
ObvioHealth deployed digital recruitment to enroll 400 participants throughout 48 states in less than one month. Subjects were stratified and randomized across four arms to test three different dosages of the study product, and one placebo group. The enrollment process, from screening to signing eIC, was completed virtually with no site visits.
The entire clinical data management process - gathering, storing, and analyzing data points for critical insights - was designed and carried out by ObvioHealth. Participants input data directly into our app, while our clinical operations team remotely monitored clinical efficacy, GI tolerance, and the like-ability of the study product(s).
• The client received the data it needed to launch one of the products.
• ObvioHealth successfully achieved database lock within four weeks of LPO.
• Researchers maintained 85% questionnaire compliance and experienced only an 8% dropout rate.
New Study: Monitoring and Clinical Assessment of COVID-19 Patients from Home
We are currently planning a study with a specialty pharma company to test the efficacy and safety of a treatment for Covid-19. Studies to date conducted on treatments like Remdesivir have focused on intravenous medications for hospitalized patients. Yet the majority of patients with COVID-19 are, fortunately, not being hospitalized. They are told to self-isolate, rest, and take symptomatic medications. This highlights a significant unmet medical need for an oral, easily administered medication for treatment of symptomatic COVID-19 patients at home. Until recently, it was assumed that patients needed to travel for certain types of research related assessments. However, inroads in the development of accurate and 510(k)-cleared medical devices for in-home use enable patients in clinical trials to do much of this from home, opening up a world of opportunity for more convenient capture of real-world data.
Evaluate the safety and efficacy on non-hospitalized COVID-19 patients of an oral investigational drug.
We will conduct a randomized, double-blind, placebo-controlled hybrid study. Participants will enroll at a clinical site and be sent home with study drug and several devices to collect both telemetric information and patient-reported information in order to measure the safety and efficacy of the investigational treatment. Measurements will include temperature, respiratory and pulse rates, blood pressure, pulse oximetry, electro cardiogram (ECG) and weight.
Home healthcare nurses will make four in-home visits to check-in on patients, collect blood samples for certain laboratory parameters, perform virus PCR swabs at home, and assist in certain patient-reported data capture, using devices provided to participants at home.
While it is too soon to point to any results, an immediate benefit of this approach is the level of convenience provided to participants. By structuring the study for only a single initial site visit and then following with a combination of ePRO, device use and in-home visits, we are able to minimize the disruption inpatients’ lives while cost effectively collecting high quality and reliable data.
Fill in the form below to speak with our clinical operations team today about our virtual clinical trial solutions:
Accelerated Timelines: It goes without saying that virtual clinical trials (aka digital clinical trials) can speed project timelines. Why? Take recruitment. Virtual trials often recruit samples in a third of the time it takes traditional clinical “site-based” models. This is due the lack of geographic restraints, the ability to recruit untapped populations that may not have been aware of trial opportunities and the power of smart social media advertising copy to engage relevant targets more effectively. In addition to the ability to more quickly pinpoint ideal targets, digital recruitment allows for easy changes to strategy when needed. All this adds up to what can sometimes be radically shortened timelines.
Enrollment is also accelerated through an electronic consent process. And real time remote monitoring (link to remote monitoring LP) enables study teams to identify hiccups quickly and take the necessary steps to course correct when participants fall off track, miss deadlines or make errors. The higher level of engagement and retention minimizes trial disruption and enabling studies to be completed on or before target.
Cost Savings: Virtual clinical trials can reduce costs significantly for many of the same reasons that they accelerate timelines. There is a direct correlation between fewer delays, increased operational efficiency, and cost savings. Moreover, virtual clinical trials avoid many or all of the costs associated with site operations and site monitoring. Additionally, site-based studies which are less convenient for participants often require higher compensation. This is why site-based studies often see costs rise exponentially before enrollment is complete. Remote recruitment and remote-based monitoring can provide comparable results for a fraction of the cost.
Safety: Last, but certainly not least, virtual clinical trials are safer for participants and researchers than traditional clinical trials. While the disruption caused by the pandemic, and its associated site closures and dropouts have been a real challenge for the industry, virtual clinical trials have been largely left unaffected. Another factor which contributes to the safety of virtual clinical trials is the ability to monitor for and alert for adverse events much sooner than in a site-based trial. No need to wait until the next site visit, the patient can report concerning symptoms as they happen. And the study team can see the data in real time. This allows the team to act quickly and appropriately for the safety of the patient.
An Observational Study on Crying and Fussing Events in Babies
Caregivers recorded their infants’ crying /fussing and used the ObvioHealth app to share their perception of each event through daily questionnaires and e-diaries. Parents’ reported crying/fussing frequency was 2-4 times higher than audio-recorded events.