How Has Clinical Trial Monitoring Adapted to Today’s Complex Trials and Decentralized Trials?

Clinical trial monitoring is the process of ensuring that a clinical trial is conducted following the protocol and that the rights, safety, and well-being of trial participants are protected. Clinical trials have become increasingly complex over time due to technological advances that allow for more sophisticated studies.

Moreover, the COVID-19 pandemic has significantly catalyzed the adoption of decentralized clinical trials, which involve bringing an increasing proportion of a trial’s activities to the patients rather than using the traditional paradigm of bringing patients to a trial site. In this article, we will explore how clinical trial monitoring has adapted to these changes and what are the benefits and challenges of decentralized clinical trials.

Table of Contents

Traditional Clinical Trial Monitoring

Traditional clinical trial monitoring involves frequent on-site visits by monitors, who are appointed by the sponsor, to verify that the reported trial data are accurate, complete, and verifiable from source documents and that the conduct of the trial is in compliance with the protocol, Good Clinical Practice (GCP), and the applicable regulatory requirements1. On-site monitoring also allows monitors to assess the performance and quality of the trial site, provide training and support to the site staff, and identify and resolve any issues or risks that may arise during the trial.

However, a traditional clinical trial monitoring system has some limitations, such as:

It is costly and time-consuming, as it requires travel, accommodation, and logistics expenses for the monitors and the site staff.
It may not be feasible or safe to conduct on-site visits in some situations, such as during a pandemic, a natural disaster, or a political unrest.
It may not be sufficient or effective to detect and prevent data quality issues, fraud, or misconduct, as it relies on a sample of data and documents that may not be representative of the whole trial.
It may impose a burden on the trial participants, who have to travel to the trial site for frequent visits, undergo invasive procedures, and comply with strict schedules and protocols.

Decentralized Clinical Trial Monitoring

Decentralized clinical trial monitoring is a non-traditional clinical trial model that utilizes technology and processes to create options for participation beyond an exclusive physical presence. Clinical trial monitoring services and site management work in tandem even for hybrid trials. Decentralized clinical trials can either be fully remote or adopt a hybrid approach where some physical-site attendance is required. They are achieved with the use of remote monitoring and diagnostics, home health providers, local labs, digital capture of consent data, and direct-to-patient drug distribution. The purpose of these types of studies is to reduce or eliminate the requirement for face-to-face interactions between researchers and participants.

Decentralized clinical trial monitoring has several advantages over traditional clinical trial monitoring, such as:

It improves the accessibility and convenience of clinical trials for the participants, who can participate from their homes or local settings, with less travel, time, and cost involved.
It enhances the diversity and representativeness of the trial population, as it allows for the inclusion of participants who may otherwise not take part in site-based research, such as those who live in remote areas, have mobility issues, or belong to underrepresented groups.
It increases the efficiency and quality of clinical trials, as it enables real-time data collection and analysis, reduces data entry errors and missing data, and facilitates adaptive trial designs and interventions.
It reduces the workload and costs for the trial sponsors and investigators, as it decreases the need for on-site visits, site management, and data verification.

Best Practices and Recommendations for Implementing Decentralized Clinical Trial Monitoring

To overcome the challenges and barriers of decentralized clinical trial monitoring, and to ensure its success and quality, some best practices and recommendations are:

Conducting a feasibility assessment: Before initiating a decentralized clinical trial, it is important to conduct a feasibility assessment to evaluate the suitability and viability of the trial design, the technology and service providers, the trial population, the trial site, and the regulatory environment. This can help to identify and mitigate the potential risks and issues and to optimize the trial performance and outcomes.

Selecting the appropriate technology and service providers: Decentralized clinical trials should select the technology and service providers that can meet the specific needs and requirements of the trial, such as the data collection and analysis methods, the data security and privacy standards, the technology compatibility and usability, and the customer support and service quality. Moreover, decentralized clinical trials should establish clear and transparent contracts and agreements with the technology and service providers, and monitor and evaluate their performance and quality throughout the trial.

Developing a risk-based monitoring plan: Decentralized clinical trials should adopt a risk-based monitoring approach, which involves identifying and prioritizing the critical data and processes, and applying the appropriate monitoring methods and frequency, based on the level of risk and impact. This can help to ensure the data quality and integrity and to reduce the cost and burden of monitoring. Some of the monitoring methods that can be used in decentralized clinical trials are remote source data verification, centralized statistical monitoring, and triggered on-site visits.

Ensuring data quality and integrity: Decentralized clinical trials should implement rigorous measures to ensure data quality and integrity, such as validating the data sources and devices, encrypting and anonymizing the data, applying data quality checks and audits, and reporting and resolving any data discrepancies or anomalies. Furthermore, decentralized clinical trials should adhere to the data management and reporting standards and guidelines, such as the CDISC standards and the CONSORT statement.

Providing adequate training and support: Decentralized clinical trials should provide adequate training and support to the trial staff and the participants, to ensure their competence and confidence in using the technology and devices, and to ensure their compliance and adherence to the trial protocol. The training and support can be delivered through various channels, such as online tutorials, videos, manuals, webinars, phone calls, or chatbots. Additionally, decentralized clinical trials should solicit and incorporate feedback and suggestions from the trial staff and the participants, to improve the trial design and execution.

Engaging stakeholders and regulators: Decentralized clinical trials should engage and communicate with the relevant stakeholders and regulators, such as the ethics committees, the institutional review boards, the data safety monitoring boards, the health authorities, and the patient advocacy groups, to ensure their awareness and approval of the trial objectives, methods, and outcomes. This can help to build trust and collaboration and to facilitate the regulatory approval and acceptance of the trial results.

Future Trends and Opportunities of Decentralized Clinical Trial Monitoring

Decentralized clinical trial monitoring is a promising and innovative approach that can transform the way clinical trials are conducted and monitored. However, it is still in its early stages of development and adoption, and there are many opportunities and challenges ahead. Some of the future trends and opportunities of decentralized clinical trial monitoring are:

Leveraging artificial intelligence, blockchain, and wearable devices: Decentralized clinical trials can leverage emerging technologies, such as artificial intelligence, blockchain, and wearable devices, to enhance data collection and analysis, data security and privacy, and patient engagement and retention. For example, artificial intelligence can enable automated and adaptive data analysis and interventions, blockchain can enable secure and transparent data sharing and verification, and wearable devices can enable continuous and passive data capture and feedback.

Integrating real-world data and evidence: Decentralized clinical trials can integrate real-world data and evidence, such as electronic health records, claims data, social media data, and patient-reported outcomes, to complement and enrich the trial data, and to support the trial design and execution. This can help to increase the generalizability and applicability of the trial results and to accelerate the drug development and approval process.

Collaborating across sectors and regions: Decentralized clinical trials can foster collaboration and coordination across different sectors and regions, such as the academia, the industry, the government, and non-governmental organizations, and across different countries and continents, to share the best practices and lessons learned, to harmonize the standards and regulations, and to expand the access and reach of the trial population. This can help to improve the quality and efficiency of the trial conduct and outcomes and to advance scientific knowledge and innovation.

Conclusion

Decentralized clinical trial monitoring is a novel and evolving approach that can offer many benefits and advantages over traditional clinical trial monitoring, such as improving the accessibility and convenience of clinical trials for the participants, enhancing the diversity and representativeness of the trial population, increasing the efficiency and quality of clinical trials, and reducing the workload and costs for the trial sponsors and investigators. However, decentralized clinical trial monitoring also faces some challenges and barriers, such as regulatory uncertainty, data security and privacy, technology reliability and usability, patient engagement and retention, and ethical and legal implications.

Therefore, decentralized clinical trial monitoring requires careful planning and implementation, and adherence to the best practices and recommendations, such as conducting a feasibility assessment, selecting the appropriate technology and service providers, developing a risk-based monitoring plan, ensuring data quality and integrity, providing adequate training and support, and engaging stakeholders and regulators.

Moreover, decentralized clinical trial monitoring can leverage future trends and opportunities, such as leveraging artificial intelligence, blockchain, and wearable devices, integrating real-world data and evidence, and collaborating across sectors and regions, to further enhance and optimize its performance and outcomes. Octalsoft’s clinical trial monitoring services are a promising and innovative approach that can transform the way clinical trials are conducted and monitored, and ultimately, improve the health and well-being of society. Want to know more? Book a demo with our experts today!