The Age of Remote Clinical Trials
Remote clinical trials are clinical studies that allow patients to participate from home using digital technologies instead of visiting research sites for every study activity. These trials use tools such as telemedicine, mobile applications, wearable devices, and remote patient monitoring to collect clinical data, communicate with participants, and manage study workflows. Remote trials are designed for pharmaceutical companies, clinical research organizations (CROs), and healthcare innovators seeking to improve trial accessibility, recruitment, and data collection.
The value of remote clinical trials is faster patient recruitment, broader participant diversity, and improved patient convenience. By reducing the need for in-person visits, these trials make it easier for patients to enroll and stay engaged, particularly those who live far from research centers or have limited mobility.
Remote clinical trials typically combine digital consent systems, remote data collection tools, wearable devices, telehealth visits, and integrated clinical data platforms. These technologies allow researchers to monitor patient outcomes, collect study data, and manage trial protocols without relying entirely on physical trial sites.
As clinical research continues to adopt digital health technologies, remote and hybrid trials are becoming an important model for improving the efficiency, scalability, and accessibility of clinical studies while maintaining data quality and regulatory compliance.
Challenges in traditional clinical research
Traditional clinical trial systems suffer from inefficiencies caused by multiple factors affecting sponsors, contract research organizations (CROs), clinical investigators (CRAs), site staff, and patients, including low recruitment and retention rates, long data management process, clinical decision support, shortage of human resources in clinical research and so on.
New approaches are being applied to recruitment, obtaining informed consent, collecting remote outcome measures, and delivering interventions, and some studies are being conducted entirely on technology platforms. To ensure the compliance and safety of research participants, the U.S. Food and Drug Administration (FDA) has issued guidance for industry, researchers, and other stakeholders conducting technology platform-enabled research.
Seven technologies that support remote clinical trials
- Remote patient monitoring in real-time
- Digital recruitment and enrollment
- Electronic consent
- Collecting data through biomarkers and biosensors
- Risk-based monitoring
- Real-time location tracking systems
- Telehealthcare
Remote patient monitoring
Remote monitoring is an emerging approach to clinical trial management that has the potential to improve efficiency, reduce costs and increase the number of trials conducted in resource-limited settings.
Digital Recruitment and enrollment
Recruiting participants in randomized controlled trials (RCTs) is challenging. Recruiting through digital tools, such as social media, data mining, email, or text messaging, adds channels to reach out to specific groups of people. For example, the Metastatic Breast Cancer Project signed up almost 3,000 volunteers in a year of using social media, with 95% completing the required survey.
Electronic consent
Informed Electronic Consent includes a variety of processes to obtain informed consent using supporting electronic information, ranging from onsite device-based signatures to fully remote Internet-based methods.
Collecting data through biomarkers and biosensors
Wearables classifications differ according to Gartner, IEC (The International Electrotechnical Committee), and Berkeley typology, but the idea remains: there is a type of sensor for any request. Wrist-worn wearable devices can collect Actigraphy, HR (Heart Rate), BP (Blood Pressure), EDA (Electrodermal activity), skin patches can track ECG (Electrocardiography), actigraphy, skin temperature, and wearing a ring on a finger can measure heart rate and SpO2.
At the same time, validating wearables remains a challenge. There are regulatory guidelines about validating wearable devices and sensors from the FDA, but they are a bit too general. The wearable manufacturer and the test sponsor are responsible for investing in research to prove the validity.
Risk-based monitoring
Monitoring is an FDA-mandated process whereby the integrity of the clinical trial process is validated. There are five types of adverse events:
- death
- a life-threatening drug experience
- inpatient hospitalization or extension of one for more than 24 hours
- a congenital anomaly/congenital disability
Remote risk-based monitoring can detect critical data and process errors, and onsite monitoring offers an effective alternative to traditional onsite tracking of clinical trials.
Real-time location tracking systems
Real-time location tracking systems (RTLS), or indoor positioning or location systems, are primarily used for tracking individuals and equipment in indoor environments in real or near-real time. They are used in many focus areas, from cognitive health to activity recognition and change of habits. RTLS technologies provide valuable data and can be a helpful tool in analyzing patterns of human behaviors
Telehealthcare
Using telemedicine options in future protocol designs will benefit rural and remote communities that lack new therapies and are often excluded from clinical trials due to distance and face-to-face assessment requirements. It is therefore essential to recognize that sponsors should be willing to invest in the additional infrastructure necessary to enable telemedicine for research studies.
Benefits of virtual clinical trials
Real-life setting.
In a virtual clinical trial environment where patients and study monitors are remotely located, people are monitored as they go about their daily lives.
The benefits of remote monitoring include lower costs, increased efficiency, reduced burden on participants, and improved access to Healthcare services. These benefits may be significant in developing countries with limited infrastructure, and people often lack access to medical care. However, there are potential drawbacks, including concerns over data quality, security, and privacy issues.
Passive Data Collection
When a patient spends time entering data, this is considered “active data.” When a patient’s health is monitored in a way that does not require manual data entry, it is called ‘passive data.’
Passive data collection bypasses the “reporting barrier” when patients must manually enter their health information. Passive data can be collected continuously. Because patients wear the devices, their motivation to participate in the trial does not influence data collection.
Expanding diversity
The concept of conducting clinical research at home existed before the pandemic. The main goal was to improve patient comfort and experience. Since typically 70% of potential participants live two or more hours away from the study site, decentralization expands access to research, reaching more patients, and a potentially more diverse patient pool can be achieved.
Decentralization can also reduce the researcher’s workload, as traditional onsite activities (such as drug administration, assessment, and data review) can be performed remotely by others or by the research participants.
Conclusion
We can expect virtual trials to remain limited to a narrow set of use cases, such as a well-characterized drug with few adverse events in a mild indication, with endpoints suited to remote measurement. While most clinical trials are not likely to be entirely virtual, they will use one or more decentralization elements based on suitability for their endpoints, patient populations, and treatments.
But because of all the benefits that remote trials can do, including reduced costs, we will see more hybrid clinical trials with elements of both traditional clinical trial design and tools from decentralized trials. Clinical trial sponsors creating hybrid protocols benefit from the provision of decentralized services and technology interventions, including remote monitoring of vital signs, mobile clinics, and home visits. Traditional site visits are still necessary for complex procedures and specialized investigations such as screening and magnetic resonance imaging. Intelligent hybrid study designs, therefore, virtualize other touchpoints or bring them as close to the patient as possible.
February 2025
FAQ
What are remote clinical trials?
Remote clinical trials are studies that allow participants to join and complete trial activities without visiting a research site for every step. Digital tools such as telehealth platforms, mobile apps, and wearable devices are used to collect data and communicate with participants. This approach increases accessibility while maintaining structured clinical research protocols.
How do remote clinical trials collect patient data?
Data in remote trials is typically collected through connected health devices, mobile applications, patient-reported outcome tools, and telehealth consultations. These technologies enable researchers to gather vital signs, activity data, symptoms, and treatment responses from participants in their everyday environments while maintaining secure data transmission.
What are the benefits of remote clinical trials?
Remote trials make participation easier by reducing travel requirements and allowing patients to contribute from home. This can increase recruitment rates and improve participant diversity. It also allows researchers to collect real-world health data and monitor patients more frequently during the study.
Are remote clinical trials fully virtual?
Not all remote trials are fully virtual. Many studies use hybrid models, combining remote data collection with occasional in-person visits for procedures that require clinical supervision. This approach balances patient convenience with the need for controlled clinical assessments.
What technologies enable remote clinical trials?
Remote trials rely on technologies such as telemedicine platforms, wearable sensors, remote patient monitoring devices, and secure clinical data systems. These tools allow researchers to manage participant communication, collect study data, and monitor safety while maintaining regulatory and data protection requirements.