Decentralized clinical trials, also known as remote or virtual clinical trials, have gained significant momentum in the research industry. They offer the convenience of participating in clinical research from home, reducing the need for physical visits to research sites. In fact, in 2021, over 95% of research sites utilized some form of decentralized technology, highlighting their growing popularity.
Benefits and Availability:
Decentralized clinical trials offer numerous benefits, ranging from improved patient reach and enrollment to enhanced patient experiences and compliance. These trials facilitate data collection, leading to more reliable and comprehensive results. To explore the advantages of decentralized trials and their impact on clinical research availability, please visit our blog.
However, it's important to consider the potential pitfalls associated with decentralized trials. Here are the key limitations to be mindful of:
Lack of Supervision: A significant drawback of decentralized trials is the absence of direct supervision by medical professionals. Unlike traditional trials where patients are closely monitored for their safety and well-being, decentralized trials involve geographically dispersed participants, increasing the risk of adverse events.
Ease of Manipulation: Decentralized trials present a challenge in maintaining data integrity due to the potential for unethical behavior. Participants have more freedom and flexibility, making it easier for them to manipulate data, such as by deviating from prescribed medication or providing inaccurate medical information. This compromises the trial's integrity and can lead to misleading or unreliable results.
Limited Access to Facilities: Decentralized trials may require specialized equipment or facilities for comprehensive data collection. Unlike traditional trials, where researchers have access to various diagnostic tools, providing participants with the same resources in their respective locations can be challenging. This limitation affects the accuracy of conclusions regarding treatment safety and efficacy.
Need for Training: Participants in decentralized trials must possess a high level of technical proficiency. Unlike traditional trials with detailed instructions, decentralized trials may involve the use of multiple technologies, including mobile apps, online surveys, and video conferencing. This may be daunting for participants who are not technologically inclined or lack the necessary equipment and internet connectivity.
Additional Cost of Instruments: Decentralized trials can incur higher costs compared to traditional trials. In addition to the physical research site and staff expenses, researchers may need to invest in additional technology and infrastructure to support remote participation. This increased cost can pose challenges for companies or research organizations, particularly when the return on investment (ROI) is unclear.
While decentralized clinical trials offer significant benefits, researchers and pharmaceutical companies must carefully consider the potential pitfalls before adopting this approach. It is crucial to have experts onboard who can analyze trial efficacy, identify challenges, and effectively manage resources. At Coherence Health, we provide solutions to the challenges faced by modern clinical trials through our AI-equipped monitoring system, ensuring accurate data and a user-friendly experience for patients. Contact us for a consultation to optimize your clinical trial and enhance the experience for all stakeholders.