Virtual Clinical Trials: Shaping the Future of Modern Medical Research

Clinical trials are designed to study the effects of different interventions on various groups of people, but one of the biggest barriers to participating in a trial is geography. Without a wide pool of participants, it can be difficult for some clinical studies to accurately assess the efficacy and safety of a new intervention, while some studies may not be able to go ahead at all.

Addressing the geographical barrier is key for clinical researchers, and that’s where virtual clinical trials (VCTs) can be invaluable. By taking advantage of advancing mobile health and digital technologies, VCTs can address this hurdle, while also improving other aspects and challenges of clinical trials.

What is a virtual clinical trial?

Virtual clinical trials (VCTs), also referred to as remote, digital, decentralized, or siteless trials, use digital technology to carry out trial-related processes and procedures.

Researchers in a VCT may use several digital tools to connect with participants and monitor results. These often include mobile devices, apps, online platforms, wearable technology, electronic patient report outcomes (ePRO) devices, and virtual patient monitoring techniques such as source data verification (SDV)

How is a virtual clinical trial different from a traditional clinical trial?

The main difference between VCTs and traditional clinical trials is location. In traditional trials, participants must attend a research site regularly for monitoring and data collection. In VCTs, participants can take part remotely. It is thought that up to 70% of participants in a traditional clinical trial live more than 2 hours from the closest trial site, often leading to dropouts and burdensome travel requirements.

Data collection is another key difference. Trained intermediaries collect data in a traditional clinical trial, but data is collected remotely in a VCT, through digital technologies like wearable devices, mobile apps, and ePRO devices. Information access is also different, with researchers able to use messages and online chat features to keep in contact with participants. In turn, this can improve engagement and patient convenience.

For sponsors, virtual clinical trials are often much cheaper to undertake than traditional trials as the need for a large study site and more resources is reduced. Virtual clinical trial recruitment is also cheaper and easier, with a much larger pool of participants to attract, which can be done online to further save costs. This also means that enrolment is quicker, with informed consent given online too. VCTs can provide a larger and more diverse patient pool than traditional clinical trials because the need for extensive and frequent travel is removed.

Tools and technologies used in virtual clinical trials

Digital tools and technologies form an integral part of a virtual clinical trial, enabling researchers to collect participant data remotely, engage participants, manage data, and ensure the smooth running of a trial. Without this technology, VCTs - and even hybrid trials - would not be possible.

By using tools such as eConsent, ePRO, telemedicine, wearable devices, and remote patient monitoring, participants can take part in a VCT from the comfort of their living or working environment, making them more convenient, accurate, and efficient.

eConsent

One of the initial steps in a VCT is informed consent, and researchers can use an eConsent form to obtain this from participants, instead of having them attend a research site. By enabling participants to review study protocols in their own time, eConsent can improve transparency, enhance participant understanding, and ensure regulatory compliance. This technology can also be used to support reconsenting if protocols change.

ePRO devices

Electronic patient-reported outcomes (ePRO) devices are designed for data capture. They are commonly used to gather data on a participant’s activities and health status, including symptoms, behaviors, functionality, quality of life, and health outcomes. Participants use these tools on their electronic or mobile devices to directly report and submit their health information. This gives researchers access to instant data.

Telemedicine

Similar to ePRO devices, telemedicine is used to remotely monitor patients and provide healthcare services. Telemedicine facilitates long-distance participant and clinician contact, care, advice, reminders, education, intervention, monitoring, and remote admissions. It also includes video conferencing, which can be a vital tool in patient care.

Sensors and wearable devices

To enable greater data collection on participant health and treatment response, many virtual clinical trials use sensors and wearable devices. Researchers can use these digital devices to analyze a variety of data, including heart rate and variability, activity tracking, sleep, haptics, glucose monitoring, electro-stimulation, sweat analysis, UV tracking, and pressure sensors.

Benefits of virtual clinical trials

Virtual clinical trials offer many benefits to both participants and medical researchers, from enlarging the recruitment pool to decreasing the time it takes to enroll participants.

Enhanced participant access and diversity

Perhaps the most significant benefit of VCTs is the ability to broaden participant diversity and inclusion, as well as access to a particular trial. Traditional clinical trials commonly have trouble recruiting and retaining participants, limiting their participant pool to specific geographies.

This challenge in traditional trials has been so prevalent that the FDA published guidance documents on the gap of under-representation of minority groups. The guidance states that adopting a wide range of baseline characteristics may create a study population that more accurately reflects how the new therapy will perform in the real world where this diversity is reflected if approved.

In virtual clinical trials, the geographical barrier is removed, increasing the ability to recruit and retain a larger pool of participants from a wide variety of backgrounds. Additionally, VCTs are increasingly being used to recruit participants for studies into rare diseases, where a broader geographic scope is essential for curating a sufficient sample size.

More informed patients

Virtual clinical trials make use of digital technology, which is often used to deliver more information to participants. Through study websites, consent portals, and greater access to clinician contact, patients are more aware of the study conditions and can better educate themselves. This virtual access also supports participant engagement and can give patients quick answers to any queries or concerns they may have during the trial.

Reduced clinical trial costs

In virtual clinical trials, cost efficiencies can be found for a variety of stakeholders, including participants, researchers, and sponsors. Participants do not need to travel to a research site, therefore removing their reimbursable transport expenses. Additionally, missed appointments due to an inability to travel can cause rescheduled visits in traditional clinical trials, which leads to additional site staffing fees. With VCTs, these costs are eliminated.

Site fees, maintenance costs, and hospitalization/research center service charges are completely removed from the requirements of a virtual clinical trial. As trial activities are centrally managed by a remote study coordination center at a much lower cost than traditional trials, investigator fees are also reduced, and onsite management costs are removed.

With the increasing use of technology for remote patient monitoring and data collection, the requirements for in-person monitoring are dramatically reduced, decreasing the associated resource costs. With the removal of patients visiting sites and VCTs taking a risk-based approach to monitoring, there are also fewer requirements for source data verification (SDV) at investigational sites.

Shorter enrolment periods

By using digital platforms and social media to recruit a wider range of participants in more geographical areas, virtual trials can enroll participants much quicker. Most of the time, enrollment is online, increasing the speed it takes to reach the required patient numbers with less money spent doing traditional participant recruitment.

Expedited data collection and accuracy

With VCTs using digital tools and wearable technologies, real-time data collection is a possibility. This speeds up the time it takes to generate and analyze data, therefore also reducing the timeline of the trial and reducing costs for sponsors. By utilizing technology, data collection is also more accurate. Inbuilt data validation, cleansing, and verification in the tools reduce or remove the time to query, correct, and recapture inaccurate or uninterpretable data.

Sponsor benefits

For sponsors, virtual clinical trials are proving to revolutionize the clinical trial landscape, particularly in relation to recruitment, accuracy, and cost efficiency. It is currently estimated that only 5% of adults in the U.S. have participated in a clinical trial, but VCTs are expected to enable this number to increase.

Challenges of virtual clinical trials

VCTs, while beneficial, can also come with a number of challenges for both research teams and participants.

Feasibility depending on the condition

In some types of research, depending on the condition and requirements or objectives of the trial, virtual clinical trials are not feasible. As an example, participants in oncology trials may need to undergo scans of tumors for researchers and doctors to establish whether their cancer is responding to treatment. This would not be possible in a virtual clinical trial.

Electronic data management and integrity

With the increased digital aspect of virtual clinical trials, there can be data privacy and security concerns for both participants and researchers. While data collection is much easier in virtual clinical trials, there is an increased need for electronic data management. VCTs often generate large quantities of data that need to be analyzed and protected, meaning sponsors need to take additional measures that safeguard participant privacy.

The security of any technological devices used by participants is also crucial, as they can be vulnerable points of entry for data breaches, compromising the integrity and success of the trial. Sponsors must also ensure they comply with data protection laws including GDPR in Europe and HIPAA in the USA. Data protection policies should be clearly documented and patient consent to data handling gained during enrolment.

Data integrity can also pose challenges in VCTs. For example, participants may enter incorrect data into their devices, leading to inaccurate results. Additionally, the ability to handle, manage, standardize, and validate large quantities of data can be difficult without the right expertise in this field.

Additional training or resources

Remote participation in virtual clinical trials is enabled by technology. This means end-users must be trained in how to use it, which can be costly and time-consuming. Improper or insufficient training in digital tools and devices used may also lead to mistakes in data collection, poor quality data, or poor communication between participants and research teams.

Technological challenges

Researchers must design virtual clinical trials in a way that means digital tools are accessible and easy to use for participants of all ages and technical abilities. Different tools should also be tested before the trial starts to ensure they work together seamlessly, avoiding problems once the trial begins. Researchers may need to enlist the help of technology experts to ensure the digital tools they are using are fit for purpose.

Participant engagement and retention

While removing geographical barriers with virtual clinical trials should improve retention, and digital communication should improve engagement, sometimes VCTs can have issues with these factors. Digital fatigue may be a problem, with some participants being overwhelmed or disinterested in the trial if there are too many digital tools, devices, and requirements. For example, wearable devices may be uncomfortable for some participants and they may remove them, leading to a lack of data.

A lack of human interaction can also cause problems in engagement, with a sense of connection and commitment becoming lost. Research teams need to ensure they develop strategies for keeping participants engaged and interested, utilizing digital technology and personalized communication to improve experiences.

Non-sterile environments and real-world settings

Remote trials take place in real-world settings, often meaning there are fewer controls on potential drug interactions. Traditional clinical trials allow for in-person monitoring and governance to ensure the trial is conducted in a sterile and secure environment. However, with VCTs, the home environment could lead to greater discrepancies and potential ailments.

Recognizing and addressing challenges with virtual clinical trials

While challenges can occur in virtual clinical trials, as they have gained prominence, there are several ways that researchers are addressing and overcoming them.

Overcoming the digital hurdle

Digital tools are a vital element in VCTs, and ensuring participants can use them effectively is key. Researchers are ensuring that participants are provided with the necessary devices and broadband services to make sure they can participate regardless of their location or economic status. In line with this, researchers are also partnering with community centers and libraries in some locales, facilitating internet and device access for participants.

Training on digital devices is also carried out, ensuring participants are fully aware of how to use the technology effectively, empowering them to take control of their health and participate completely. VCT teams are also ensuring participants have access to help desks if technical issues occur, whether it's difficulty in app downloads, connecting devices, or following usage instructions.

Dealing with data privacy and security concerns

With large amounts of data, privacy and security can be a concern. Sponsors and CROs should stay ahead of data privacy requirements and cybersecurity risks, enabling them to put systems in place that ensure compliance and data protection. To support this, researchers are using techniques like pseudonymization and data minimization to make sure personal data is not readily identifiable. Regular security audits are also carried out to identify and address vulnerabilities before they cause issues.

Staying updated with the evolving regulatory environment

Regulations are continually evolving, especially in the digital world, which means researchers need to stay continually updated and follow best practices. As well as considering ways to ensure patient safety and data protection, research teams can also collaborate with regulatory bodies to help shape the development of practical and effective guidelines.

Trial organizers must also ensure that the regulatory bodies they are submitting to are aware of all trial techniques and follow their guidance. Factors for consideration include:

• Source data verification
• Patient adherence
• Informed consent
• Indication and operational issues

Ensuring appropriate trial design

Every clinical trial is different, whether traditionally run or virtual. Deciding the right design for a trial requires a deep understanding of the patient population, desired outcomes, and trial risks. While establishing design is a little easier with traditional trials, VCTs can incur more challenges in design. Sponsors and research teams must work with virtual clinical trial experts who can design a digitally-enabled and suitable approach for the population, condition, and treatment under study.

As VCTs gain more prevalence, more researchers are establishing a digital skillset or seeking the help of professional virtual clinical trial experts.

Opting for a hybrid approach

Clinical trials don’t just need to be on-site or remote. A hybrid trial is very much a possibility since researchers have more access to technology that enables a virtual element. In hybrid clinical trials, researchers take elements from both traditional and virtual clinical trials to design a study that has the potential to reach a wider population, while still reaching the desired outcomes.

Hybrid trials enable patients to go to a research site for some parts of the trial and utilize remote visits for others. The hybrid approach is beneficial for high-risk trials or those studying rare diseases, since frequent site visits can be undertaken alongside remote patient monitoring.

How virtual clinical trials are conducted

Virtual clinical trials follow a similar format to traditional clinical trials, with certain elements changed to incorporate virtual elements.

Ethical and regulatory approval

While ethical and regulatory approval is also completed in a traditional clinical trial, this first step in a VCT may be done remotely. Documents to obtain ethics committee approval can be submitted online before members of the ethics committee meet virtually to discuss and issue research approvals. The process for gathering regulatory approval from licensing authorities may also be completed online.

Identifying participants

The next step of a VCT is to identify suitable participants, which can be a common challenge in all types of clinical trials. Artificial intelligence (AI) tools can be used to search through electronic medical records to find potential participants for clinical trials, before matching them to appropriate studies. This speeds up the process and can be particularly helpful in finding participants for rare disease trials.

Recruitment and screening of participants

Once suitable candidates have been identified, researchers can start to plan outreach. If you’re identified as a suitable candidate based on your medical records and consent preferences, you may be contacted by your healthcare professional or directly by the trial organizers.

If there have not been enough candidates identified through medical records, researchers can use several recruitment strategies to find suitable candidates. This may include community outreach, social media, digital advertising, and partnerships with healthcare organizations. As part of the recruitment process, researchers will also screen potential participants to ensure they are eligible to take part in the trial. This could include physical examinations, interviews, and reviewing medical records.

Consenting and enrollment of participants

Establishing participation consent, including informed consent, for a clinical trial is an important and complex process. It involves providing participants with all the trial information they need to know, giving them time to understand it, and raise any questions they have. In traditional trials, consent, and enrollment are often carried out during multiple site visits, which can be a deterrent to participation. However, in VCTs, guidance, information, and informed consent can be delivered online.

Administration of study interventions

In traditional clinical trials, participants would visit the research site to receive study interventions. In virtual clinical research, participants might administer the treatment to themselves or have it administered by a nurse at their home. If a hybrid approach is being used, participants may still be required to visit a study site for treatment before reporting their results virtually.

Care of study participants

Throughout a clinical trial, participants will be assessed periodically and receive medical care to ensure compliance with the trial protocol and allow any toxicity to be identified. In virtual clinical trials, these assessments may be carried out in a number of ways, including home visits by research nurses or video and tele-consultations. The method of assessment and care will be decided based on the trial objectives, the intervention, and the data to be collected.

Assessment of efficacy and safety outcomes

Ensuring efficacy and safety outcomes are assessed reliably and timely is a vital part of any research study. However, in traditional trials, this can be time-consuming. Virtual clinical trials can speed up this process by using digital devices to gather real-time participant data that can be programmed to directly provide the information to the research team. Additionally, researchers in VCTs can gather outcomes via questionnaires, sent by email, telephone, or video consultations, further improving the speed at which these results are provided.

Study monitoring

Participants are continuously monitored throughout a clinical trial, ensuring study protocol compliance, preventing participant harm, and ensuring data is reliably captured. In virtual clinical trials, researchers commonly monitor participants using digital devices and tools such as wearable technology, virtual consultations, and online questionnaires, and by having participants report on their health outcomes.

The future of virtual clinical trials

Virtual clinical trials are gaining more prevalence as the intersection of healthcare and technology continues to create innovative solutions to some of the clinical research landscape’s most common challenges. As health tech progresses, AI and machine learning (ML) will continue to be used to support clinical trials, whether virtual or not. We expect to see AI and ML play a key role in VCTs, particularly concerning recruitment and data collection and analysis.

New technologies being used in virtual clinical trials will support researchers in creating studies that can easily adapt to specific patient diagnoses and symptoms, bringing the research industry closer to the idea of personalized medicine. The increased use of technology in global clinical trials may also improve collaboration among pharmaceutical companies, technology providers, and regulatory agencies, resulting in standardized and optimized virtual trial processes.

Having the ability to leverage data will also further increase the amount of virtual clinical trials we see in the industry. Studies may integrate real-world data from electronic health records and other real-world resources to enhance study outcomes alongside data collected from the trial. Patient-centric designs could also become more prevalent, with trials designed as per patient preferences to improve participation numbers and subsequent engagement levels.

Conclusion

Virtual clinical research, while not a new concept, is continuing to gain momentum in the clinical research landscape. From implementing virtual elements to create a hybrid trial to designing completely remote trials that are more easily accessible, it’s clear that virtual clinical trials are becoming the future of modern medicine. VCTs are not only beneficial for participants who will now have more access to innovative treatments, but they also support the wider medical community through enhanced data collection, speedier trial timelines, and reduced costs.

If you’re interested in participating in a clinical trial, whether virtual or not, we can help find the right clinical trial for you.