Decentralized clinical trials are transforming the clinical research industry. And, with change comes new questions and uncertainties for trial sponsors like you. Let us equip you with answers so you can make smart decisions about your trial design.
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How virtual can my study go?
Every sponsor wants their study to have high compliance, adherence, and retention rates, while also collecting the necessary data to meet desired trial outcomes. Most trials will require some combination of traditional trial elements and decentralized components. The decentralized modules help to reduce patient burden and facilitate remote data management and monitoring. Studies that require face-to-face medical oversight or intervention can also employ certain decentralized elements to minimize on-site activities.
If your primary endpoint is ePRO-related or can be accurately captured remotely by an in-home device or home testing kit, your study may be appropriate for a 100% virtual design.
Some trials will require site or doctor’s visits but can still benefit from integrating virtual methods. The goal is to identify touchpoints that can be enhanced with decentralized solutions.
Find out whether hybrid or full DCT best suits your protocol
Get More AnswersCan a DCT deliver the level of data accuracy my study requires?
We know that capturing quality outcomes and effectively monitoring the safety of a clinical trial requires more than traditional ePRO solutions can offer. Our clinically focused technology platform reduces friction in outcomes capture, reduces patient burden, and leads to more reliable endpoints.
One of the most important elements in ensuring data accuracy is the ability to capture data in real time. No parking lot syndrome on our trials. The ObvioHealth app enables patients to report symptoms as they experience them.
Attention to data accuracy is designed into every detail of ObvioHealth’s next-generation platform, tools, and processes, enabling us to not only meet but surpass the data accuracy typically delivered on a traditional trial. Our clinical science expertise is brought to the fore during the design phase to ensure that the right instruments are used to get to the right endpoints.
The data from patients is immediately transferred to ObvioHealth’s customized dashboard where it can be viewed in real time by our COACH (Clinical Oversight And Coordination Hub) team. If there is straightlining, missed reporting, discrepancies between device and ePRO data, or if we see other anomalies, our support teams reach out to patients in real time for clarification.
Our data science team ensures the quality of data analysis at the back end. We perform automatic data cleaning, auto-edit checks, and advanced query resolutions as the data is entered. This improves our ability to quickly identify discrepancies that might suggest a change in behavior or user. And, because our data is all in one place and minimal data cleaning is needed at the end of a study, our average time between LPO and database lock is 7 to 10 business days.
It is essential to train patients on concepts such as accuracy and honesty in reporting, as well as the importance of ePRO compliance and medication adherence. In addition, subjectivity is reduced whenever possible by using patient images, audio, video, or wearables and biosensors to ingest patient data streams. Patient data can then be reviewed and scored by central expert raters to reduce inaccuracy in reporting.
Can DCTs maintain patient engagement?
ObvioHealth’s COACH (Clinical Oversight And Coordination Hub) team is an essential part of our recipe for success. Our CRO roots have taught us that tech alone can’t deliver solid study outcomes. The tech can make participation easier and less burdensome. But, strong patient engagement requires both Tech and Team. Participants need a human connection—someone they can easily reach out to with question… a real person at the other end of the study to whom they feel accountable. ObvioHealth has designed our tools to be run by our own experienced in-house team. The platform facilitates the team’s providing of support and assistance and the real-time monitoring of adverse events. Integrated devices capture data on vital signs which can be visualized in real time on data dashboards. Our Tech + Team approach to DCTs results in higher retention and adherence.
88%
Percent Retention Rate
Percent of participants enrolled in an ObvioHealth trial that complete the study
90%
ePRO Completion Rate
Percentage average of ePRO Completion Rate in completed ObvioHealth studies
One-on-One Patient Support
ObvioHealth’s COACH (Clinical Oversight And Coordination Hub) team engages with patients on every step of the journey—from eConsent to data collection. The COACH team is trained to reach out to patients proactively, as well as to respond to any patient questions or concerns. Notifications and alerts remind the patient to complete study tasks. Our tech also notifies the study team when a patient is falling behind, so they can reach out on a personal level to get them back on track.
Design Studies with Engagement in Mind
Keeping patients engaged also requires the right study design. Our clinical research team understands how to design a study that captures accurate endpoints while reducing patient burden, ultimately delivering better data to the sponsor.
An Intuitive User Experience
Our technology is designed to deliver an easy user experience using UX design best practices, including gamification, milestone marking, and other techniques proven to promote continued engagement. Participants can often provide the data needed with the simple tap of a button. Sliding scales and other easy digital tools facilitate reporting
How can I ensure patient safety?
Patient safety in a clinical trial begins with the careful review and approval of a protocol and continues through ongoing monitoring to ensure that potential risks are anticipated and that a system of alerts is put in place to address issues as soon as they arise.
Real-Time Reporting and Monitoring
In a traditional trial setting, a patient leaves a site, and, many times, the adverse event only comes to light at the next visit. The ObvioHealth platform enables real-time monitoring of adverse events. Patients respond to a daily question on the app to determine whether anything in their medical status has changed. If affirmative, the system asks further questions to capture the scope of the issue. Integrated devices also offer the option of capturing data on vital signs which can then be visualized in real time on data dashboards.
Immediate AE Detection and Resolution
This data from the patient is immediately transferred to custom-built dashboards where it can be viewed in real time by ObvioHealth’s COACH (Clinical Oversight And Coordination Hub) team. If an AE is suspected, the team will follow up with the patient personally and create an electronic case report. We use Med Dra to code each event in the back end. We can also export AE/SAE data to sponsor databases.
On-Demand Virtual Site Team
Participants can make contact with ObvioHealth’s COACH team at any time. They can choose their preferred communication method—chat, email, or phone—ensuring they get the information they need when they need it.
Deep Clinical Operations Experience
At ObvioHealth, we believe experience is key. We have developed and validated over 250 ePRO/PRO solutions across various therapeutic areas, leading to successful outcomes and endpoints.
17 Therapeutic Areas
Over the past 5 years, we have worked across 17 therapeutic areas, enabling us to gain powerful insights into how to adapt decentralized trials to specific protocols.
Client Roster
In this short time, 7 of our 21 clients have given us repeat business—the greatest proof of satisfaction.
40+ Studies in 28 countries
ObvioHealth is a truly global organization. We have run trials in 28 countries across 5 continents.
Case Study #1
Studying the Efficacy of a Medical Device on Urinary Incontinence
Pelvic floor muscle training (PFMT), or "Kegel" exercises, is considered the most effective, non-invasive treatment for stress urinary incontinence and stress predominant mixed urinary incontinence. However, more than 75 percent of women perform PFMT exercises incorrectly, even with verbal or written instructions.
Objective:
Evaluate the efficacy of a Class II digital therapeutic device compared to standard care of PFMT exercises to treat SUI/SMUI.
Methodology:
The first fully virtual study to be run in the urogynocology space, this prospective, randomized controlled study recruited participants via digital media targeting and signed them via electronic informed consent (eIC), using the ObvioHealth app to complete enrollment. Instruction material (video plus explanatory placard) was provided for the Kegel group; those in the treatment arm performed PFMT with the device's assistance.
Patients answered validated questionnaires via the app to assess changes in health outcomes. Exercise adherence, patient perceptions, and AEs/SAEs were monitored regularly via the app and visualized on live platform dashboards by our COACH (Clinical Operations And Coordination Hub) team.
There were no required office visits in this study. Upon randomization, subjects received three scheduled phone calls from the COACH team for education on PFMT exercises. For the remainder of the study, patients received additional phone calls regarding the treatment plan and safety monitoring.
Results:
Recruitment was completed with 350 participants enrolling in the trial in just 3.5 months. Regular interactions with our COACH team engaged and encouraged patients throughout the study, resulting in an 89% retention rate and a 95% ePRO compliance rate. The study delivered statistically significant results for the device versus control Kegel groups for both of the primary outcomes. We would not have had this outcome without it being a virtual study. In contrast, I was running an FI study and drop-off was dramatic. We probably completed 60%.
- Robin Sutherland, VP of Clinical Operations
Case Study #2
Remote Data Collection to Determine the Efficacy of a COVID-19 Treatment
Objective:
RedHill Biopharma seeks to evaluate the safety and efficacy of an oral investigational drug on non-hospitalized COVID-19 patients.
Methodology:
Our team of clinical researchers and software engineers designed a study to allow patients to participate from home while maintaining a high level of monitoring. Patients are enrolled through a clinical site and sent home with the study drug plus several devices to collect both telemetric and patient-reported information to measure safety and efficacy signals.
Vitals measured via devices:
• Temperature
• Respiratory rate
• Heart/pulse rates
Patients are given the option of coming back to the site or of having healthcare nurses conduct in-home visits to collect blood samples for certain laboratory parameters, perform virus PCR swabs, and verify that patients are using devices correctly.
Results:
Part A of the study is currently under way to optimize dosing. Part B is slated to begin in early 2022.
Case Study #3
Assessing the Efficacy of a New Treatment for Pre-Hypertension
Objective:
A multinational company needed to assess the safety and efficacy of a treatment for pre-hypertensive adults and those at high risk of cardiovascular disease.
Methodology:
Our clinical operations team designed a hybrid study to include remote data collection to reduce the number of site visits required in a traditional study. We were able to quickly and cost effectively reach the desired cohort through digital media recruitment by digitally targeting patients more likely to have high blood pressure (eg: had purchased a blood pressure cuff and/or had visited sites providing information on hypertension).
Emphasis was also placed on ensuring the representation of African American patients, as this population over-indexes for high blood pressure. Between site visits, subjects completed daily questionnaires and our COACH (Clinical Oversight And Coordination Hub) team tracked any changes in health status.
Results:
• Successful recruitment of a diverse population: 41% Caucasian, 39% African American, 20% other races.
• Minimization of site visits via remote monitoring facilitated the collection of 56,286 data points reviewed in real time.
• The virtual team’s regular engagement with patients helped to achieve an 89% retention rate.
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