A decentralized clinical trial (DCT) is one where key trial activities—such as patient recruitment, monitoring, data collection, and sometimes even treatment administration—take place remotely, outside of traditional clinical settings like hospitals or research centers. It’s often facilitated by digital tools, telemedicine, local clinics and home delivery services.

A DCT is particularly useful in the following scenarios:

  1. Geographical Constraints
    When participants are spread across diverse locations, a DCT can eliminate the need for them to travel long distances to participate in the trial, increasing accessibility and participation rates. This is especially beneficial for rare diseases or conditions where eligible patients may be located far from specialized research centers.
  2. Patient Convenience and Retention
    If a trial’s success depends on long-term patient retention, decentralized trials can provide greater flexibility. For instance, patients with chronic conditions who may struggle with frequent hospital visits or patients in underserved communities who don’t have easy access to transportation could benefit from remote monitoring, virtual consultations, or interventions in local clinics in their communities.
  3. Chronic and Long-Term Conditions
    Trials for chronic or long-term conditions often require repeated data collection and follow-ups. DCTs allow patients to participate without needing to leave their homes, improving adherence to the trial protocol and reducing the risk of patient drop-off.
  4. Cost and Time Efficiency
    DCTs can reduce the overhead costs associated with setting up and maintaining physical trial sites (e.g., travel expenses, and site management costs). They also may reduce recruitment times because participants can more easily engage without geographic or logistical barriers.

Key Things to Get Right in Planning a Decentralized Trial

While decentralized clinical trials can provide significant benefits, they also introduce unique challenges and require different considerations in the planning phase compared to traditional, site-based trials. Here are the key elements that need special attention when planning a decentralized clinical trial:

  1. Technology Infrastructure
  • Planning for Digital Tools: In a decentralized trial, digital tools such as telemedicine platforms, remote monitoring devices (e.g., wearable sensors), eConsent systems, and data collection apps play a crucial role. Ensuring that these tools are user-friendly and secure is essential. You must plan for technical support for patients and investigators to ensure the smooth use of these tools.
  • Data Management Systems: Decentralized trials generate a massive volume of data from remote monitoring devices, patient-reported outcomes, and telehealth interactions. Having a robust, secure, and compliant data management system in place to handle this data is essential.
  • Interoperability: The digital solutions used should seamlessly integrate with other systems, including electronic health records (EHR), laboratory management, and regulatory reporting systems.
  1. Patient Recruitment and Engagement
  • Wider Patient Pool: Decentralized trials can reach a broader patient population, but recruiting patients who are comfortable with remote participation is crucial. You need to ensure that recruitment materials and processes are tailored to this model, and patients understand the level of engagement required (e.g., telemedicine visits, self-reporting, device usage).
  • Digital Literacy: Some patient populations may not be comfortable or familiar with the technology needed for decentralized trials. Consider offering training or user-friendly interfaces and providing assistance for those with limited technical skills.
  • Informed Consent: The process of obtaining informed consent remotely must be done through secure, compliant methods (such as eConsent). Special attention should be given to ensure that patients understand the risks and requirements of participating remotely, especially for trials involving sensitive health information.
  1. Clinical Monitoring and Site Management
  • Remote Monitoring: Decentralized trials require robust remote monitoring systems to ensure that clinical data is accurately captured and that patient safety is not compromised. Investigators must have access to patient data in real time to make timely decisions about treatment adjustments or adverse event management.
  • Compliance with Local Regulations: Even in decentralized trials, local regulations and ethical guidelines must be adhered to. This might involve ensuring that telehealth consultations are conducted in compliance with national telemedicine laws or ensuring that trials involving investigational drugs follow appropriate oversight by regulatory bodies.
  • Risk-Based Monitoring (RBM): In a decentralized setting, site monitoring activities may differ. You’ll need to apply risk-based monitoring techniques to ensure that remote sites and participants are meeting the required trial standards. This includes remote visits, virtual audits, and ensuring that data is complete and accurate.
  1. Patient Protection
  • Patient Safety and Adverse Event Reporting: In decentralized trials, ensuring patient safety through proper adverse event reporting and follow-up can be more challenging because investigators and staff may not have direct, in-person access to patients. Effective, timely communication channels must be in place to address emergencies or unexpected side effects.
  • Patient Data Protection: Since decentralized trials often involve electronic data collection and remote communication, robust cybersecurity measures must be taken to protect patient data. This involves ensuring encryption, secure cloud storage, and compliance with data privacy laws (e.g., GDPR, HIPAA).

 

Conclusion

Implementing a decentralized clinical trial is a strategic decision that can offer substantial benefits, especially in terms of patient recruitment, convenience, and trial efficiency. However, to ensure success, careful planning must account for key differences compared to traditional trials. Technology infrastructure, patient recruitment, logistics, remote monitoring, and regulatory compliance are areas that need special attention in the planning phase. With the right preparation, decentralized trials can unlock new possibilities in clinical research, driving greater patient engagement and broader access to clinical trials.

Refined Path has experience planning and implementing decentralized clinical trials and real-world evidence studies.  Please reach out to us if you would like to discuss.