Virtual clinical trials aren’t just a buzzword—these research models are here to stay. In fact, the global market for virtual clinical trials is expected to reach $12.9 billion by 2030, according to Grand View Research.
The growth in the virtual trials space has many sponsors asking: How do virtual studies support participants, but also clinicians and study teams? Can technology meet the needs of everyone involved while also delivering quality data and meaningful outcomes? And, the age-old question when it comes to technological advances: Will this be the development that replaces humans?
Let’s answer these questions by investigating how virtual clinical trial solutions work. We’ll explore why the best digital health technologies enhance human relationships and the patient experience—not replace them.
Virtual clinical trial solutions assist everyone involved in a study—whether it’s a fully decentralized clinical trial (DCT) or a hybrid trial. These study models can:
With all this buzz, a comprehensive deep dive into the emerging—and increasingly normalized—field of DCTs is in order.
In this post, we will provide a definition of “decentralized clinical trials,” give a sliding scale for clinical study decentralization, highlight the benefits of incorporating DCTs, as well as the challenges associated with DCTs, provide 9 principles to keep in mind when planning and deploying a successful decentralized or hybrid trial, and, finally, call out specific use cases for DCTs in both ongoing and completed clinical trials.
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In well-designed virtual clinical trials, online engagement can improve the patient experience—offering a key advantage over traditional site-based trials. Here are several ways that digitally enabled trials support participants and study teams.
Informed consent is a top priority for study sponsors for good reason. Delivering adequate information about known risks, benefits, alternatives, and possible side effects sets the stage for a strong relationship with participants.
In traditional, site-based settings, study teams are often under tremendous time pressure to screen, qualify, and enroll participants. Virtual trial vendors offer electronic informed consent (eConsent) that provides patients with the same information as standard, written consent, but digitally. eConsent delivers a self-paced experience that can include images, guided videos, diagrams, and comprehension quizzes. This patient-centric, user-friendly format helps to ensure that participants are fully informed of the risks and benefits of a clinical trial before signing on.
Giving patients access to virtual trial teams enables them to ask questions or express their concerns without feeling the pressure of a rushed site visit. In turn, creating stronger participant engagement can also boost compliance and trial completion rates.
While informed consent forms the basis for a healthy dialogue with participants, clinicians and DCT teams must continue to build this trust. This is especially true when the study population includes people who may be skeptical of the medical community, such as those from historically excluded and underrepresented groups.
In a traditional trial, patients with questions or concerns have to pick up the phone and wait for a return call—or wait for their next in-person appointment. Another issue: Patients are often uncomfortable asking questions in a face-to-face environment. In virtual trials, patients always have access to the study team, and it's as simple as a text message with an almost-immediate response.
Within a virtual trial, electronic patient-reported outcomes (ePRO) platforms and chat functions give participants convenient access to virtual clinical research teams, so they can get timely answers to pressing concerns. Virtual clinical trials companies can strengthen trust by creating open lines of communication through messaging apps, texting, and phone calls.
In this way, well-designed virtual studies can bring study teams closer to patients in the comfort of their own homes.
Constant access to the study team also supports timely reporting, documentation, and intervention to address adverse events and unexpected side effects. Virtual clinical trials allow teams to build these safeguards into the study protocol—mitigating patient risk.
In traditional trials, participants discuss health concerns at site visits, but they may forget or downplay their concerns by the time they interact with the on-site clinical team, meaning an adverse event could go unnoticed.
With a virtual trial, eDiaries will ask participants, as often as every day, if they've experienced a change in health status—and patients can answer with a few taps on a smartphone. This functionality allows study teams to detect adverse events in a way that isn't possible in a traditional trial. And, because participants have convenient access to the study team, they’re more likely to reach out with questions or concerns in real time.
Every clinical trial involves a certain degree of participant burden. When they enroll, patients agree to complete study jobs: recording symptoms, actions, and outcomes at predetermined intervals. Virtual clinical trials can streamline these tasks and make them easier to accomplish in real time, which reduces the patient burden and delivers more accurate data.
With virtual clinical trials, patients can report symptoms with the tap of a button in the study app or by permitting a medical device to collect photo, video, or audio data. Virtual clinical trial teams can incorporate electronic patient-reported outcomes (ePRO) to collect patient diaries, questionnaires, and unstructured data (audio, video, and images).
Virtual clinical trials also support data collection in therapy areas where patients might be understandably reluctant to disclose personal health information. A virtual environment can make this disclosure process more discreet, reducing the chance of embarrassment for patients. For example, if the pharmaceutical being studied may affect a patient’s libido, they may be more comfortable reporting this symptom via an app from the comfort of their own home instead of a face-to-face visit.
In fact, creating the right amount of distance between clinicians and participants can maximize recruitment and engagement for trials with “taboo” subject matter, which might otherwise struggle with a low response.
Maintaining strong participant engagement throughout a study ultimately enhances data collection. Study teams can generate more robust, accurate data using real-time data collection, which can include digital therapeutics and remote patient monitoring devices when appropriate.
Let’s consider a traditional trial in which patients report an entire day’s worth of data at bedtime. When they try to remember relevant data points, such as how many times they sneezed that day, they may experience recall bias that leads them to skew the number. The classic problems of subjectivity and human error affect studies across the range of therapeutic areas. In virtual trials, participants can use the virtual study apps to report symptoms as they experience them.
These apps can also prompt patients via a push notification or message from a trial member when trial compliance lapses. This helps patients remain compliant with the study protocol, driving data quality while causing minimal disruption to their daily routine.
DCT technologies can enhance data collection and strengthen patient-team relationships in powerful ways, but they should never be considered as a substitute for the human connection needed to ensure patient engagement and safety. Well-designed virtual clinical trials combine the ease of technology with the expertise of the study team, ultimately driving meaningful outcomes for sponsors.
Learn how digital clinical trials help to strengthen the connection between trial teams and participants.
ObvioHealth is a new breed of Virtual Research Organization (VRO) leading the long-overdue digitization and virtualization of health research to accelerate the development of innovative drugs and devices across the globe. Recently listed #390 on the list of Inc 5000's fastest growing companies, we are pioneering new ways to collect data, recruit and engage patients, and identify novel outcomes that help to bring life-improving health solutions to market, faster. Our patient-centric mobile application and platform enables subjects to use their smartphones, as well as wearables and other remote monitoring devices, to participate remotely in clinical trials from the comfort of their homes while delivering more cost-efficient and accurate data to sponsors.
Learn more about virtual clinical trial solutions by booking a demo today.Schedule a Demo