Decentralized Clinical Trials: An Overview
Decentralized Clinical Trials are important, as they can help patients participate in clinical trials from their homes or other locations. This is done using telemedicine and digital health technologies to communicate with trial investigators and complete study-related activities.
The concept of DCTs emerged in the early 2000s as a response to the growing complexities and expenses associated with traditional clinical trials. Utilizing digital technologies such as electronic data capture, telemedicine, and remote monitoring allowed for a patient-centric approach to clinical trials.
The COVID-19 pandemic accelerated the adoption of DCTs, as restrictions on travel and social distancing measures made it difficult to conduct traditional trials. Moreover, the U.S. Food and Drug Administration (FDA) and other regulatory agencies adapted their guidance to support the use of DCTs.
This blog will discuss the types, challenges, strategies and benefits. Let’s look at what are decentralized clinical trials (DCTs) below.
What are decentralized clinical trials?
Decentralized clinical trials (DCTs) are clinical trials that utilize technology to facilitate patient enrollment, data collection and monitoring from different locations. According to the FDA, a DCT is a clinical trial that uses technology to facilitate study execution and data collection, with most study activities being conducted remotely and minimal on-site visits by participants. DCTs aim to improve the efficiency, accessibility and convenience of clinical trials for both researchers and participants.
Compared to traditional clinical trials, where participants typically need to visit specific study sites for various procedures and assessments, DCTs offer a flexible and patient-centric approach. In DCTs, participants can often take part in the trial from their own homes or local healthcare facilities, reducing the need for frequent and sometimes burdensome site visits.
DCTs employ a range of technologies to facilitate remote participation, including telemedicine platforms, mobile health applications, wearable devices, electronic patient-reported outcomes (ePROs) and remote monitoring systems. These technologies enable real-time data collection and provide researchers with a more comprehensive and continuous understanding of a participant’s health status.
Why DCTs Are Used to Such a Degree
Patient recruitment and retention are two of the key reasons why DCTs are utilized. These trials help improve patient recruitment, retention, participation numbers and geographical spread and reduce site costs. These factors apply to both hybrid and fully decentralized trials.
DCTs are particularly suitable for certain therapeutic area (TA) clinical trials. Four specific TAs, namely Metabolic Disorders, CNS (Central Nervous System), infectious disease and Respiratory, account for 79% of the $7.4 billion DCT market. These therapeutic areas have seen significant utilization of DCTs.
According to a report from Clinical Trials Europe in July 2021, 71% of the surveyed participants stated that decentralized clinical trials resulted in better patient recruitment, and 74% mentioned improved patient retention. Patient recruitment and retention play a crucial role, as patients dropping out can significantly impact the time it takes to bring a drug to market. Considering the potential costs of delaying market entry, which can range from $600,000 to $8 million per day for blockbuster drugs, it’s important to avoid delays at any cost.
What are the different types of decentralized clinical trials?
There are two types of decentralized clinical trials, and which one is used depends on the degree of patient/clinician interaction and proximity to the trial site. Certain trials are better suited to specific types of DCTs. For example, in early-stage trials where there is a higher potential for adverse reactions, it is beneficial for the patient to be near clinicians.
Phase II and Phase III trials are critical stages in the development of new treatments and interventions and are particularly relevant to DCT methodologies. These trials involve larger participant numbers, making them well suited for decentralized approaches. DCT methodologies offer numerous advantages in these later stages, including improved patient recruitment and retention, reduced costs and greater convenience for participants.
In the case of clinical trials where data can be captured by connected devices, they can be conducted remotely as there is no need for specialized medical personnel on-site. Remote DCTs rely entirely on digital technologies and offer several benefits, such as greater patient convenience, reduced costs and improved patient recruitment and retention. Moreover, they also enable the participation of patients who live far away from trial sites or have limited mobility.
It is well known that patient centricity is important for the success of clinical trials, and DCTs enable a more patient-centric approach by allowing participants to be involved in trials from the comfort of their own homes. DCTs prioritize the convenience and well-being of patients. This patient-centric approach can lead to higher participant engagement, better adherence to study protocols and increased overall satisfaction with the trial experience.
The early-stage trials typically involve a lower number of study participants. However, later-stage trials, which involve hundreds or thousands of participants, are well suited to DCT methodologies due to the potential geographical spread and larger participant numbers. For instance, the development of COVID-19 vaccines utilized DCT methodologies in later stages, involving thousands of participants across multiple continents worldwide.
Tools used in decentralized clinical trial
Decentralized clinical trials rely heavily on digital technologies and tools for remote participation and data collection. These tools must be secure, user-friendly and compliant with regulatory requirements.
Several tools are used in DCTs, each playing a specific role in the decentralized trial process. These are discussed in detail below.
Wearables
It includes devices such as activity trackers, continuous glucose monitors (CGMs), heart monitors and wristbands. Wearables are typically worn by patients and can collect continuous data related to physical activity, vital signs and specific health parameters.
In-Home Devices
It includes devices that patients can use in the comfort of their own homes. Examples include blood glucose monitors, blood pressure monitors, electronic peak flow meters (used for monitoring respiratory function) and oximeters.
Mobile Healthcare
This category covers various mobile technologies and services aimed at delivering healthcare remotely. It includes remote patient monitoring (RPM), which involves the use of connected devices to track and transmit patient data; remote drug delivery systems; telemedicine for virtual consultations; and home nursing services provided through mobile platforms.
Mobile Technology
Mobile technology is the use of mobile devices and communication channels for healthcare purposes. It includes email, text messaging, webchat, smartphones, tablets and sensors. These technologies can be utilized to facilitate communication, data collection and patient engagement in clinical trials.
Web-Based Technology
This category includes various electronic tools and platforms accessible through web interfaces. Some examples include electronic data collection (EDC) systems used for capturing trial data electronically, electronic clinical outcome assessments (eCOA), electronic informed consent (eConsent), electronic diaries (eDiary), electronic patient-reported outcomes (ePRO) and questionnaires administered through web-based interfaces.
Challenges or barriers to decentralizing clinical trials
While decentralized clinical trials offer numerous benefits, implementing them has challenges and barriers. Some of these challenges are discussed in detail below:
- Finding New Technology Vendors
A primary challenge in conducting DCTs is identifying and partnering with technology vendors who can provide the necessary tools and services. This can be time-consuming and require more hard work to ensure that the vendors have the expertise and capabilities to support the trial effectively.
- Patient Data Privacy
The collection and storage of patient data in DCTs can be challenging due to privacy concerns. Researchers must ensure that patient data is collected, transmitted and stored securely to protect patient privacy and meet regulatory requirements.
- Regulatory Compliance
The GDPR and HIPAA are important regulations for data compliance. The GDPR protects personal data within the European Union and requires compliance for DCTs. Additionally, HIPAA safeguards the health information in the U.S., relevant to DCTs collecting or processing PHI. The compliance involves obtaining consent, implementing security measures and ensuring lawful data processing. DCTs must consider these regulations based on participant location and data type.
- Patient Engagement
DCTs can be complex and require patients to be more involved in the study process. Patients may need additional support to understand how to use digital technologies and complete study-related activities, impacting recruitment and retention rates.
- Digital Divide
Some patients may be unable to access the necessary technology or internet connectivity to participate in DCTs. This can limit the diversity of study populations and introduce selection bias into the study results.
- Investigator Experience
Conducting DCTs requires a different skill set and expertise than traditional clinical trials. Investigators may require additional training and support to conduct DCTs effectively.
To learn how to address them, download this white paper which briefly discusses the benefits and challenges of decentralized clinical trials.
It first highlights the benefits of DCTs, such as increased patient access, improved patient retention and reduced costs and timelines. Then, it discusses the challenges associated with DCTs, such as regulatory compliance, data security and patient privacy concerns. The paper emphasizes that choosing the right partner is vital to tackle these challenges and ensure the trial’s success.
It further provides a comprehensive overview of the various tools and technologies used in DCTs, including electronic data capture systems, mobile health (mHealth) apps, wearables, telemedicine platforms and remote monitoring devices. Additionally, the paper provides practical tips for choosing the right partner for DCTs, such as evaluating their experience, expertise and technology capabilities.
Stages of a decentralized clinical trial
The stages of a DCT can vary depending on the trial design and the digital technologies used. However, the stages in which DCTs are usually conducted are described below.
Study Planning and Protocol Development
The first stage of a DCT is study planning and protocol development. This stage involves defining the research question, selecting study endpoints, designing the study protocol and determining the digital tools and platforms to conduct the trial remotely. Additionally, study planners must ensure that the trial meets regulatory requirements and ethical considerations.
Participant Recruitment and Screening
Participant recruitment and screening are critical stages in any clinical trial. In DCTs, this stage is conducted remotely. Recruitment strategies include online advertisements, social media outreach and patient registries. The screening is done through online questionnaires, video consultations and self-administered tests.
Informed Consent and Enrollment
Once participants are identified and screened, they are asked to provide informed consent to participate in the trial. This is done remotely using electronic consent forms, video consultations and interactive digital platforms. Participants can then enroll in the trial and receive instructions on using the digital tools and platforms.
Data Collection and Monitoring
This stage typically involves remote methods, such as mobile apps, wearable devices and telemedicine platforms. Patients can record their symptoms, medication use and other study endpoints using digital tools, and healthcare providers can monitor patients remotely and provide virtual visits as needed.
Data Analysis and Reporting
The final stage of a DCT is data analysis and reporting. Data collected through digital tools are validated and analyzed using appropriate statistical methods. Then, the results are reported following regulatory requirements and disseminated to stakeholders such as sponsors, investigators and patients. DCTs may also involve real-time data monitoring and adaptive trial designs for more efficient and responsive analysis and reporting.
Benefits of decentralized clinical trials
Decentralized clinical trials aim to improve the efficiency and effectiveness of the clinical trial by leveraging digital technologies and remote monitoring. That said, below are some of the benefits of DCT according to studies.
- Increases Participant Diversity
DCTs can increase participant diversity by enabling remote participation and eliminating geographic and transportation barriers that often limit the participation of underrepresented populations. Studies have shown that DCTs can increase participant diversity, with one study reporting a 30% increase in enrollment of African American and Hispanic participants in a DCT compared to a traditional trial.
- Accelerating Patient Trials
DCTs can accelerate patient trials by reducing the time and cost associated with participant recruitment, data collection and monitoring. Studies have shown that DCTs can reduce study timelines by up to 30%, with one study reporting a 50% reduction in study start-up time and a 25% reduction in patient enrollment time.
- Improving Patient Engagement and Retention
DCTs can improve patient engagement and retention by providing convenient and flexible study participation options, such as remote study visits and electronic data collection. According to a July 2021 report, 71% of participants reported better patient recruitment, while 74% experienced improved patient retention. These outcomes are crucial, as patient dropouts can cause delays in bringing drugs to market. This increases the costs to $8 million per day for blockbuster drugs.
- Increased Safety Monitoring
DCTs can enable more frequent and efficient safety monitoring by leveraging digital technologies to collect and analyze patient data in real time. This can facilitate earlier detection of adverse events, faster response times and improved patient safety. According to a survey of clinical research professionals, 77% believed that remote monitoring could improve the safety of clinical trial participants by enabling more frequent and efficient safety monitoring.
- Enhanced Data Quality and Accuracy
DCTs can improve the quality and accuracy of trial data by reducing the risk of human error associated with manual data entry to improve data collection. This can improve the reliability of trial results and reduce the risk of bias.
A survey of clinical research professionals found that 72% believed that decentralized trials could improve trial data quality by reducing human error and improving the standardization of data collection and analysis standardization.
What to consider for a successful decentralized clinical trial
Decentralized Clinical Trials require careful planning and execution to ensure their success. The following are some key considerations to keep in mind at each stage of a DCT:
Planning Phase
Feasibility Assessment: Evaluate the trial’s suitability for decentralization by considering factors such as the study population, available technology infrastructure, regulatory guidelines and the specific therapeutic area of the trial.
Protocol Design: Design the trial protocol with decentralized elements in mind, including remote monitoring, data collection, patient engagement strategies and the equipment and technology needed for the trial, both traditional and digital.
Technology Selection: Identify and select appropriate technology platforms and tools that align with the trial objectives, can support remote data collection and patient communication, and accommodate any necessary traditional products for the trial.
Participant Recruitment and Selection
Accessibility and Inclusion: Ensure the trial design and technology solutions are accessible to a diverse participant population, accounting for factors such as digital literacy, language barriers, disabilities and the equipment required for the trial.
Informed Consent Process: Develop a robust process for obtaining informed consent remotely, utilizing electronic signatures, video conferencing or other suitable methods, while considering the equipment and technology necessary for the trial.
Eligibility Criteria: Define eligibility criteria that can be effectively assessed remotely, avoiding unnecessary burdens for participants while maintaining scientific rigor, and taking into account any traditional products required for the trial.
Remote Data Collection
Endpoint Assessments: Determine the appropriate methods and tools for collecting study endpoints remotely, such as electronic patient-reported outcomes, wearable devices, telehealth consultations and any necessary traditional products.
Data Quality and Integrity: Implement measures to ensure the accuracy, completeness and integrity of remotely collected data, including data validation, source document verification, centralized monitoring and the technology and equipment needed for the trial.
Adherence Monitoring: Employ strategies to monitor participant adherence to the trial protocol, such as electronic medication tracking, wearable sensors, virtual study visits and potentially incorporating traditional products required for the trial.
Patient Engagement and Retention
Communication and Support: Establish clear channels of communication between participants, investigators and study personnel, providing guidance, support and timely responses to participant inquiries while considering the necessary equipment and technology for the trial.
Participant Burden: Minimize participant burden by leveraging remote technologies for data collection, reducing the need for in-person visits and providing convenient options for study-related activities, including the use of any traditional products required for the trial.
Retention Strategies: Implement retention strategies tailored to a decentralized setting, including regular engagement with participants through virtual visits, reminder systems, incentives for continued participation and the equipment and technology necessary for the trial.
Regulatory and Ethical Considerations
Compliance: Ensure the trial design, data collection methods, participant privacy protection and adherence to regulatory requirements and ethical standards, taking into account the therapeutic area and any necessary traditional products for the trial.
Data Privacy and Security: Safeguard participant data by implementing secure data transmission and storage mechanisms, adhering to data privacy regulations, obtaining appropriate consents for data sharing and secondary use and considering the equipment and technology required for the trial.
Institutional Review Board (IRB) Collaboration: Collaborate closely with IRBs and regulatory authorities to address any unique considerations, obtain necessary approvals and ensure compliance when conducting a decentralized trial that may involve traditional products.
Avantor’s decentralized clinical trials research
Avantor Sciences has conducted extensive research into decentralized clinical trials. We have developed important solutions to support DCTs, including a platform for remote monitoring and a patient-facing mobile app.
Avantor’s DCT research focuses on several key areas, including the impact of DCTs on patient recruitment and retention, the role of digital technologies in DCTs and the challenges of regulatory compliance in DCTs. Learn more through this thought leadership presentation on DCTs, delivered by Avantor’s experts in clinical trials.