The COVID-19 pandemic orchestrated decentralization through remote working and thus demonstrated the numerous possibilities in remote collaboration. However, decentralization in any field presents opportunities and challenges as well. From a clinical research perspective, the opportunities in decentralization are geared towards greater efficiency and higher success rates, challenges notwithstanding. Decentralization enables greater accessibility, diversity, and even higher participant retention; factors that contribute to the success of the clinical trial. Challenges are bound to come about in the conceptualization and implementation of full or hybrid decentralization. This blog highlights the concept as well as the opportunities and challenges that come with the adoption of decentralization in clinical trials.
What are Decentralized Trials (DT)?
Decentralization simply means transferring tasks, functions, or responsibilities from a central authority to subsidiaries. Decentralization in clinical trials refers to the transfer of clinical trial functions from a single “on-site” location to various remote or “off-site” locations. Different approaches including siteless, virtual, or direct-to-patient can be employed in decentralization. At the end of the day, this should pave the way for the use of technology such as telemedicine to facilitate remote data collection and analysis. Decentralized clinical trials can be categorized broadly as follows:
Fully Remote DT: All study participants are recruited and enrolled remotely using digital health solutions. Their data is captured and transferred remotely including their consent for the trial. Studies that involve unique protocols such as the collection of clinical samples can be supported by nurses or laboratory technicians that are close to the participant’s locality.
Hybrid DT: This approach combines both on-site and decentralized methods for data collection and analysis. It is a “middle ground” that has become quite popular with large pharmaceuticals requiring integrity as well as flexibility at the same time.
The execution of fully decentralized clinical trials relies heavily on technology that can manage each phase of the trial. For example, electronic consent allows researchers to obtain informed consent from participants electronically. This not only saves time but is cost-effective. Study participants may also fill out online surveys to provide information and the researchers can in turn analyze and share results electronically. Telemedicine allows researchers to interact and follow up with participants without having to leave their physical location. This makes it possible to handle numerous participants at the same time. Participants may also be required to use their own devices to collect and share information with the researchers.
The FDA and Decentralized Clinical Trials
The U.S. Food and Drug Administration (FDA) has been immensely supportive of decentralized clinical trials despite a handful of challenges. The FDA exercises oversight of clinical trials through the newly established Clinical Trials Transformation Initiative (CTTI). This initiative is a partnership between the FDA and Duke University which seeks to identify suitable practices that improve the quality and efficacy of FDA-approved clinical trials. CTTI offers recommendations for planning and implementing decentralized trials.
Benefits of Decentralized Clinical Trials
Decentralized clinical trials offer benefits for trial sponsors as well as patients. For sponsors, decentralization facilitates enrollment and offers flexibility that results in reduced attrition rates. The clinical researchers can work remotely and this minimizes expenditures in travel and other related costs. It also enables remote and real-time monitoring of data which increases efficiency. Decentralization potentially reduces the time that it takes to complete clinical trials and introduce new drugs and medical devices to the market. Clinical trial sponsors can channel extra funds to other aspects of the study.
Decentralized trials shift attention away from the research to the patient who gets to enjoy the utmost convenience. Decentralization relieves the patient of the burden to travel to study sites regularly which can be costly and may disrupt their family and work pattern. The efficiency provided ensures that patients get to benefit from new treatments and medical devices sooner rather than later.
A Few Challenges
In spite of the numerous benefits offered by the decentralization of clinical trials, some challenges may occur. Decentralization requires significant technological investments, depending on the level and nature of decentralization. Patients who are not tech-savvy might be hesitant about taking part in such trials. Technology integration might also pose a significant challenge. Global decentralized trials might be further complicated when translation services are required.
For decentralization to bear fruits, there needs to be a functional collaboration between the trial sponsor, the patient, and the site. If technology is well utilized, it should enable seamless collaboration among the three parties. This calls for proper selection of technology to be used, prior training of patients and clinical staff, trial runs with feedback, and prudent implementation of the same.
How Does LIMS for Clinical Trial Management Support Decentralized Trials?
A Laboratory Information Management System (LIMS) for clinical trial management supports the decentralization of trials in different ways. Here are a few ways in which a LIMS for clinical trial management can provide support:
Remote Data Management & Accessibility: Data collection and management often occur remotely in decentralized trials. A LIMS for clinical trial management can facilitate this process by providing a centralized platform for managing and storing trial data. A cloud-based LIMS allows participants, researchers, and other stakeholders to access and enter data from various locations, ensuring real-time accessibility.
Sample Tracking: A LIMS is crucial in tracking and managing samples involved in decentralized trials. It can assign unique identifiers to samples, record their collection, shipping, and storage details, and track the chain of custody throughout the trial. This ensures sample integrity and traceability, even when samples are collected from different locations.
Data Integration and Standardization: A LIMS for clinical trial management can integrate data from different sources and standardize it to ensure consistency and compatibility. It can collect data from various devices, wearables, or electronic health records used in decentralized trials, helping to aggregate and harmonize the data for analysis and reporting.
Remote Monitoring and Alerts: A LIMS for clinical trial management can enable remote monitoring of trial activities and generate automated alerts. It can track participant enrollment, compliance, and protocol adherence, triggering notifications or reminders when necessary. This helps ensure study adherence and prompt intervention when required.
Regulatory Compliance: A LIMS can support decentralized trials by maintaining compliance with regulatory requirements. It can enforce data security, privacy, and confidentiality standards, ensuring participant data is handled securely per applicable regulations.
A LIMS for clinical trial management is vital in supporting decentralized trials by providing a robust infrastructure for remote data management, sample tracking, data integration, monitoring, collaboration, and regulatory compliance.
Decentralized Trials Will Shape the Future of Clinical Research
The COVID-19 pandemic highlighted the significance of virtual and remote collaboration in clinical trials. It is clear that all stakeholders stand to benefit from the decentralization of trials through reduced costs, reduced attrition rates, greater efficiency, and higher productivity. Patients are the ultimate beneficiaries when new and effective treatments are introduced into the market sooner rather than later and at a competitive price point. A LIMS for clinical trial management enables laboratories to adapt to the technological demands that come with decentralization. Given the numerous benefits that come with this, there is likely to be greater adoption of fully remote, virtual, and hybrid decentralized trials in more labs across the globe.