The digital clinical trial revolution has transformed all aspects of our lives. As our devices become increasingly connected and access to information flourishes, new categories have emerged.
Health is one of the industries with the greatest potential for innovation. Yet, because it has been less beholden to user preferences, the clinical research industry has been late to adopt digital clinical trials, moving slowly to implement the digital tools that hold the key to safer, more efficacious therapeutics.
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From on-site to on-the-go data reporting.
A once novel concept, electronic (health) data capture (EDC), first introduced in the 1980s, has taken decades to catch on; start-up technology costs made digital transfers more challenging, and pharmaceutical giants were heavily reliant on paper-based, on-site reporting. However, the growing use of web-based software by investigational sites has more recently led to broad adoption of EDC technology, which in turn has spawned the birth of the digital clinical trial.
Today, increasing bandwidth, improved WIFI, and bluetooth technology are driving new ways to capture data at the point of origin, rather than transcribe or move it from one repository/system to another. This has led to digital transformation in clinical trials based on esource data, where EDC is just one of the electronic sources.
The Transcelerate cross-industry esource initiative defines esource as inclusive of four categories of data:
1. Electronic Health Records (EHR) – collected and/or reused for clinical research.
2. Devices and apps- Data coming from electronic patient-reporting (ePRO), wearables, sensors, and clinical outcome assessments by medical staff (eCOA).
3. Non-CRF - Data collected from third-party safety labs, imaging, and other data that isn't into a case report form.
4. Direct Data Capture (DCC) - Data entered directly by site staff during a trial.
Enhanced operational efficiency brings new challenges.
The technology revolution that opened the door to electronic patient-reported outcomes (ePRO) and digital health technologies such as wearables and in-home medical devices has expanded operational capabilities and boosted efficiency. But it has also created challenges, as there has been limited interoperability between data systems.
Legacy contract research organizations (CROs) who have run trials through their sites for decades are scrambling to reinvent the way they operate, moving towards more patient-centric designs equipped to manage the collection of data sets from disparate sources. By contrast, companies like ObvioHealth are part of a new wave of VRO's (Virtual Research Organizations) built from the ground up to run anything. Still, nothing but digital clinical trials and are transforming the clinical trial experience.
Digital clinical trials are faster, more secure, less complicated, and better at generating the information required to drive innovation. They are a tremendous asset to the research industry and a valuable resource for developing enhanced therapeutics.
Digital Clinical Trial companies like ObvioHealth generate quality data by creating and implementing clinical trial protocols that streamline data collection and achieve faster enrollment, higher compliance, and greater retention.
Digital clinical trials are digital end to end. The virtual site teams use social media and other digital tools to target trial cohorts more efficiently than on-site HCPs. Many of the trials are 100% remote, enabling people to participate from the comfort of their homes.
Virtual studies are so much more convenient for participants that they do a better job keeping them engaged from start to finish. Engaged patients are more likely to adhere to study protocols (reporting health-related endpoints more reliably), use wearables to capture data more easily, and consume the study product more regularly, with gentle nudges from digital clinical trial coordinators to remind them when they forget to comply. For researchers, this means more robust, real-time data that is more representative of health-outcomes in the real-world.
Here’s further evidence in support of digital capabilities over outdated systems:
Up to 4x Quicker
ObvioHealth digital trials to date have recruited participants 2-4 times more quickly than traditional trials. Many individuals are unaware of the trials which might be relevant for them. We can fill recruitment because we can reach them more effectively online, providing access to trials for individuals residing too far from a clinic or research center or those who aren't enrolled in a patient database.
48% Higher Medication Adherence
People often forget to take their medication, and the situation is no different for participants. ObvioHealth has developed an effective interplay between tech and team to increase adherence. This involves sending automatic notifications to participants to remind them to take their medication or use the product. The digital nature of reporting enables us to see any drop-off in reporting and quickly reach out to participants to understand and correct any issues.
60% Fewer Dropouts
Our clinical trials incorporate a patient-centric design that makes participation less complicated and burdensome for participants, either minimizing or eliminating required site visits. This seamless participant journey with personalized support from start to finish makes for a seamless digital experience.
We'll help you design and optimize your next digital trial.
Next-Gen Data Capture for Real-World Insights
Ask any clinical trial manager. He or she will tell you that trying to capture vitals data from participants when they make only occasional visits to a clinic is a real challenge. Take blood pressure, for example. People get nervous when coming to a clinic.
As a result, their blood pressure can often rise when being recorded by a doctor or nurse. "Whitecoat hypertension" is a known phenomenon, leading to higher readings in the clinic than at home.
Given the importance of accurately measuring the impact of a study product on health outcomes, including blood pressure, the advantage of at-home readings to minimize the whitecoat effect is self-evident, with the potential to provide a more accurate representation of how the product will perform in the real world.
Complete Data Sets
Most site-based clinical trial teams are familiar with the following scenario: a participant is seen sitting in his/her car or the waiting room, frantically trying to complete his or her study activities before an appointment.
ObvioHealth's more user-friendly approach to digital clinical trials makes this scenario much less likely. Because data-entry is more comfortable and quicker for participants, they only need to tap on their smartphone screen to report medication adherence, complete a digital questionnaire, or report a symptom or side effect.
Remote monitoring can be set up to alert researchers concerning health-related endpoints in real-time. With participant approval, wearable devices/sensors provide the added benefit of continuous and passive data from vitals measurements.
A digital clinical study design can transform an overburdened participant, who reluctantly finishes study activities, into one who remains engaged and adherent to the protocol. Better compliance rates translate to better data and, ultimately, more comprehensive information for sponsors. See below for the proven methods we use to drive high compliance rates throughout the clinical trial journey.
Efficient Recruitment & Enrollment
Traditional clinical trials are often hard to recruit. ObvioHealth utilizes digital recruitment methods that engage untapped participant pools. This can help people who are struggling to cope with their symptoms of disease/condition but don't realize that a clinical trial is available to them.
Digital clinical trial recruitment allows our team to target potential participants as they browse social websites or submit queries to a search engine instead of relying purely on physician referrals. An electronic informed consent document (eIC) then enables participants to review a given protocol's details and sign on once they are comfortable.
During this time, the study staff is available via text or phone to resolve concerns and answer questions. After enrollment is completed, research materials can often be sent directly to participants without having them go to a clinic or hospital for pickup. In addition to making the participant's life more comfortable during recruitment and enrollment, these digital recruitment strategies also address some of the hurdles of the under-representation of both minorities and particular demographics in clinical research.
Study Team Engagement Prompts
Prompts: Reminders (via smartphone notifications) pertaining to required study activities encourage participants to stay on course, thereby increasing protocol compliance.
Access to study team: Participants who have a question or concern have direct access to a research team member through a chat function available within the app.
Outcomes Measurement Made Easy
ePROs (diaries, adherence reporting, etc.) – In ObvioHealth's digital trials, participants download our app and interface with their smartphone to submit electronic patient-reported outcomes (ePRO).
By leveraging the app, patients have access to study activities both when at-home or while on-the-go. Our clinical research staff and knowledgeable tech team work closely to design easy-to-complete questionnaires, patient diaries, and other digital reporting tools.
With a direct line of communication with the study staff, it only takes a moment to ask questions or obtain help with troubleshooting.
Image, audio, and video capture – Self-reporting can be supplemented by technology to reduce bias and/or errors during data entry. For example, during a recent study, ObvioHealth instructed parents to provide photos of their infants' stools instead of relying solely on patient reporting accuracy.
Two off-site study coordinators were able to properly assess the stool consistency and color based upon the captured images. A final review showed that parents often graded their infant's sample as 'normal' when, in reality, the expert analysis provided a more accurate representation of the samples.
A separate study implemented a recording device to capture audio of crying/fussing events among infants. Mothers were instructed to record the crying/fussing manually. After analyzing both data sets, researchers identified inconsistencies between data derived from the devices and data reported by mothers. Parents, possibly influenced by exhaustion, submitted data that showed crying times up to 4x longer than the recorder.
Device Integration – A study protocol designed to support wearables and/or digital devices allows for continuous and passive data collection without increasing patient burden.
By eliminating manual data entry for vitals measurements, we minimize error during data input, gaining a complete view of the range in each vital over time while allowing participants to avoid disruption in their daily lives.
Are you sure your study requires site visits?
Speak to our clinical operations team today about using digital tools to minimize or eliminate site visits.
Many of our clients understand the benefits of digital research but need assistance imagining a fully virtual protocol or transitioning an existing protocol to take advantage of digital components.
The most common questions we receive are:
• "What kind of protocols are best adapted to digital clinical trials?"
• "How can I be sure the data collected remotely will be accurate?"
• "How do you integrate with sponsor or site data?"
Of course, each trial needs to be assessed based on its specific objectives. Still, from experience on 30+ digital clinical trials, we can confidently state that there is more potential to go virtual in your protocols than you may think. We have worked across more than 16 therapeutic areas and 28 countries designing and running trials that are either partially or fully virtual.
The hybrid trials have integrated site data seamlessly side-stepping the issues with complex EDCs by collecting the data from the sites at the source and channeling it directly into our cloud.
A couple of examples may help to bring the digital clinical trial experience to life:
• 400 study subjects recruited in 28 days
• 85% questionnaire compliance
• <10% of the allocated budget spent during recruitment
A leading plant-based food company sought to explore consumer likeability and gastrointestinal (GI) response regarding a reformulated fiber snack bar's consumption.
ObvioHealth utilized its proven digital recruitment strategy to target and enroll 400 study subjects across 48 states in the continental U.S. in under one month. Researchers randomized participants into four separate arms to test three separate dosages of the ingredient and one placebo group. From initial targeting to final review/singing of eIC, the complete enrollment process was carried out virtually (zero site visits).
Approach (Pt. 2)
From data collection and storing to final analysis, the complete clinical data management process was constructed and performed by ObvioHealth. When participants reported health-related outcomes via the app, the research staff could remotely monitor clinical endpoints related to efficacy, GI tolerance, and consumer perception of the product.
• The client leveraged the data to launch its product successfully.
• Database lock was met within four weeks of LPO.
• 92% of participants completed the study
One of our current studies aims to measure the safety and effectiveness of a COVID-19 treatment developed by a specialty biopharmaceutical company. Current clinical trials on treatments like Remdesivir have been conducted on hospitalized patients with constant on-site monitoring. However, most COVID-19 patients have been directed to quarantine at home. This creates an unmet demand for a clinically proven COVID-19 treatment designed to be taken orally at home. Until recently, it was assumed that patients would need to visit a research center or clinic for health-related measurements during such a trial.
The swift emergence of 510(k)-cleared medical devices for at-home use has legitimized remote participation in pivotal research studies. Researchers can capture more robust, real-world data points that provide more precise insights on clinical outcomes.
Determine the safety, tolerability, and efficacy of a COVID-19 oral treatment in at-home patients.
Approach (Pt. 1)
This study is designed as a randomized, double-blind, two-part hybrid study (minimized site visits) with a placebo group. Patients with symptomatic, diagnostically confirmed COVID-19 will be enrolled at a research center. Once enrolled, participants will be sent the study product and multiple digital devices to collect ePRO and telemetric data to assess safety, efficacy, and tolerability from home.
Approach (Pt. 2)
Patients will receive training to ensure they understand how to operate each device; vitals measurements will include respiratory and pulse rates, electrocardiogram, blood pressure, pulse oximetry, and temperature.
In-home visits will be conducted in intervals throughout the study. Medical personnel will check-in on patients and retrieve blood samples for specific laboratory parameters, conduct virus PCR swabs, and assist with data capture/troubleshooting with any study tools.
This study is ongoing, so results cannot yet be determined. However, ObvioHealth has worked closely with the sponsor to create a protocol conducive to high engagement, compliance, and retention rates.
By supplementing data collected in-person with remote monitoring and ePRO, we have minimized required site visits to just one initial baseline reading. By alleviating the pain points of traditional trials, digital clinical trials produce higher quality, more complete data.
Other Benefits to Going Digital for Researchers
A digital (or virtual) clinical trial design can be deployed to keep studies on track. For example, in traditional clinical trials, recruitment is often completed by HCPs who supply patient referrals from their database. This is usually a slow-moving process, filled with travel requirements, disruption to daily routine, etc. Digital recruitment strategies and remote monitoring enable digital clinical trials that were previously improbable.
Real-time Data Visualization
Easier aggregation of data at the back end also enables real-time monitoring by study teams and reporting to sponsors who can see how a study progresses and make strategic decisions more efficiently.
The safety benefits of digital trials go without saying. The COVID-19 pandemic forced researchers to shut down sites to adhere to safety guidelines, but thanks to the digital transformation in clinical trials, studies are back up and running. The inclusion of remote monitoring into protocols allows researchers to pay close attention to concerning health-related data. As a result, the clinical operations team is alerted to potential AE/SAE in real-time, enabling immediate action to prevent symptoms from worsening. Gone are the days where patients must call or schedule a site-visit to report health-related concerns.
Digital clinical trials eliminate many of the cost factors associated with conventional 'on-site' research. Digital targeting and econsent minimize sluggish enrollment. By reducing disruption, operational expenditures, and patient burden, researchers eliminate many avoidable expenses that inflate the final cost of a study. With fewer expenses related to site operations (on-site recruitment, monitoring), sponsors can implement a cost-effective trial design that takes less time to complete, thus staying within budget from recruitment through end-of-study.
Electronic Data Capture may have taken decades to catch on, but COVID-19 has accelerated the transformation to digital clinical trials exponentially. ObvioHealth was already conducting these trials four years ago. Today, we are at the forefront of making them a reality for patients and sponsors worldwide.
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