The Rise of Decentralized Clinical Trials & Virtual Clinical Trials: A CRO Perspective
Decentralized clinical trials (DCTs) and Virtual Clinical Trials (VCTs) have emerged as a pivotal innovation, offering new ways to conduct research that are more patient-centric, efficient, and flexible. DCTs and VCTs have continued to be a trending topic in the pharmaceutical world, with popular events like ASCO and DIA featuring them throughout learning sessions.
As a leading Contract Research Organization (CRO), CMIC Group is at the forefront of this evolution, harnessing the potential of DCTs to revolutionize drug development. In this blog post, we share key insights into the world of decentralized clinical trials from our unique perspective.
What are Decentralized and Virtual Clinical Trials?
According to the U.S. Food and Drug Administration (FDA), decentralized clinical trials, otherwise known as DCTs, can be any clinical trial endeavor conducted outside of a standard trial site. This often
involves remote methods, minimizing the need for participants to leave their homes to receive treatment. Meanwhile, Virtual Clinical Trials (VCTs) take this a step further by enabling the entire trial process to occur remotely, leveraging digital tools and technologies to create a fully virtual experience. These shifts are driven by advancements in digital technology, the need for greater patient convenience and diversity, and the lessons learned during the COVID-19 pandemic, which underscored the importance of flexibility in clinical research.
One of the primary benefits of both DCTs and VCTs is improved patient engagement. By leveraging digital tools such as telemedicine, mobile health apps, and wearable devices, we can reach a broader and more diverse patient population. This inclusivity not only enhances recruitment rates but also ensures that trials are more representative of real-world populations.
DCTs and VCTs enable real-time data collection and monitoring, which is crucial for timely decision-making and ensuring patient safety. At CMIC Group, we utilize telemedicine technologies to track patient progress continuously, whether in decentralized settings or fully virtual trials. This approach allows us to detect potential issues early and address them promptly, thereby maintaining the integrity of the trial and safeguarding participant well-being.
Navigating Decentralized Clinical Trials with a CRO
Navigating the regulatory landscape is a critical aspect of conducting decentralized clinical trials. In 2024, regulatory agencies worldwide have become more supportive of DCTs and VCTs, recognizing their potential to enhance trial efficiency and patient access. However, it is essential to ensure that these trials comply with all relevant regulations and ethical standards.
CMIC Group has developed robust protocols to ensure that our decentralized trials meet regulatory requirements while maintaining high ethical standards. As one of Japan’s largest CRO’s, we pride ourselves as a strong Japan decentralized clinical trial vendor. For more details on decentralized clinical trials in Japan, we’ve created a free guide for you to reference.
Often the success of decentralized trials hinges on the seamless integration of technologies like wearable devices and proper services. This includes e-consent forms, remote monitoring devices, and secure communication platforms. At CMIC Group, we invest in services to support our decentralized trial operations. With solutions like patient call centers and help desks, your patients will feel comfortable participating in a DCT/VCT.
Looking Ahead: The Future of Decentralized Trials
While decentralized or virtual clinical trials offer numerous benefits, they also present unique challenges. These include ensuring patient adherence to trial protocols, managing diverse data sources, and addressing potential technical issues. For the success of your trial, be sure your vendors have the right solutions for your specific needs.
The future of clinical trials is off-site considering the benefits for patients, researchers, and the pharmaceutical industry. From enhanced patient engagement to real-time data monitoring, these trials are transforming the way we conduct clinical research.
As a leading CRO, CMIC Group is dedicated to harnessing the potential of decentralized trials to drive innovation and improve patient outcomes. You can learn more about our Decentralized Clinical Trial and Virtual Clinical Trial solutions and start the conversation with CMIC today.
Resources
U.S. Food and Drug Administration (FDA)
de Jong AJ, van Rijssel TI, Zuidgeest MGP, van Thiel GJMW, Askin S, Fons-Martínez J, De Smedt T, de Boer A, Santa-Ana-Tellez Y, Gardarsdottir H; Trials@Home Consortium. Opportunities and Challenges for Decentralized Clinical Trials: European Regulators’ Perspective. Clin Pharmacol Ther. 2022 Aug;112(2):344-352. doi: 10.1002/cpt.2628. Epub 2022 May 17. PMID: 35488483; PMCID: PMC9540149.
