Decentralized clinical trials (DCTs) have gained popularity quickly. However, it’s only recently that technology has made it possible for a clinical research organization like Veristat to control DCTs more efficiently. As a result, most involved parties are not ready for such trials. Therefore, crucial considerations must be made to make DCTs successful. A few of these include
Site worker training
To assist the transition to a decentralized strategy and ensure the proper procedures and training are in place. Switching to other data sources in clinical trials can be difficult even for seasoned research staff. This transformation may be managed with clear procedures and thorough training to smooth the transition and boost trust using decentralized methods. To facilitate the behavioral adjustments needed to conduct more adaptive but scientifically rigorous investigations, consider progressively integrating DCT concepts in a hybrid model that mixes in-person and remote visits. This will ease the transition.
Understanding the patients and stakeholders
Take time to understand the demands and goals of all parties involved, including patients. Decentralized Clinical Trials study designs should consider how to balance patient safety and data quality with the needs and expectations of all stakeholders. Patient requirements should be the primary consideration for any decentralized technique. Since decentralized clinical trials aim to have more patient access, you learn who your patients are and what they need. Some patients prefer to check in via telemedicine calls, while others prefer to have their blood drawn at their neighborhood pharmacy rather than the primary research location.
Patients may value the convenience of off-site visits but may feel conflicted about the perceived quality of treatment they are receiving and the trial experience as a whole. The sponsor might include decentralized approaches in the study protocols to accommodate patient needs. Ask patients for their opinions on the decentralized procedures you employ in your studies.
Consider the potentials and limitations of technology
Lastly, Decentralized Clinical Trials need technology for collecting, processing, and storing data. The different technologies complicate the methods and planning necessary to guarantee data quality. Apps and wearable technologies may offer real-time data, make patients’ lives easier, lighten the load on sites, and eliminate the requirement for source data verification. Still, they also increase the volume of inputs and the difficulty of managing it all. Community-based or decentralized trials are more easily accessible to patients. However, they must still generate reliable, excellent data demonstrating whether treatment is secure and efficient.
You’ll need to implement policies, standard operating procedures (SOPs), and training for reviewing, managing, standardizing and analyzing the data gathered and vetting the technology suppliers and the technologies themselves. How, then, do you control the risks posed by technology? Before adoption, test the technology on patients and offer comprehensive, user-friendly instructions. Create channels for online platforms to respond to queries via phone, video call, or online chat. In addition, site staff members must be knowledgeable of the technology to instruct patients on it. They must also connect with their sponsor, CRO, or coordinating center using internal technologies, such as electronic Investigator Site Files (ISF).
Simple actions such as training site workers and understanding your patients and stakeholders can help you improve the outcome of the clinical trials. It allows you to identify potential issues early and devise ways to mitigate them. It also helps you spot tools and technologies that expedite the trial process.
Comments are closed.