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Patient access to research facilities decreased by 80% as health system resources were consumed by COVID-19-related care, and movement was limited by physical distancing. From January 2020 to April 2020, monthly trial initiations decreased by 50%, with 60% of investigators reporting a significant drop in trial activity in May 2020.
Remote clinical trials exist between mobile health and digital technologies, resulting in various options to support the remote trial. Remote trials can overcome infrastructure and recruitment challenges, allowing multiple locations to be used simultaneously.
Currently, the central nervous system and cardiovascular spaces are on top in integrating wearable or sensor devices in clinical trials, but rare diseases and oncology are not far behind.
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.
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.
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.
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.
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.
Monitoring is an FDA-mandated process whereby the integrity of the clinical trial process is validated. There are five types of adverse events:
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 (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
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.
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.
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.
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.
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.