Medidata offers tips on decentralized clinical trials
Preventing Pitfalls
Medidata, which provides data, AI powered insights and patient-centric solutions for clinical trials, offered solutions for five potential pitfalls of adopting decentralized clinical trials (DCTs) in a blog. Despite the obvious advantages of DCTs, sites need to consider the proper adoption, implementation and execution, the authors explained. Much of the focus is on technology design and implementation, but there are several other key considerations.
Use a whole-system approach to DCT design
Design clinical trials to fit the situation. Choose design options for in-clinic vs. virtual trial (or a combination), study-specific labs vs. regular clinical care, inclusion of electronic health records and embedded design. According to Holly Robertson, PhD, director of advisory services at Medidata, “There’s a temptation to try everything, but you really should focus on evaluating what you need, why are you including it in the design and what will you get out of it. The key is to work smarter, not harder.”
Consider patient experience
Include patient partner groups as part of the study design and operational execution strategies. Make study materials patient-friendly, engaging and tailored to different patient populations. Use a patient portal to streamline patient participation and offer feeedback. Give patients options for participation, but strike the right balance. As Robertson says, “The engagement strategy is key, so patients are adhering to requirements and incentivized to stay around.”
Understand the regulatory implications
According to Medidata, the regulatory landscape is changing to adopt new technologies while maintaining patient safety and data privacy. Know that some countries and regulatory agencies are more ready than others. Hold conversations early and often, providing clear messaging on strategy and technology to avoid delays.
Develop strategies to support change management
Have site engagement and training to support adoption of new strategies and technologies. Be aware that sites may have concerns with maintaining oversight. Make site representatives partners in the design and operational execution of trials. According to Robertson, “Sites may be hesitant to adopt new engagement models. Education and training for study personnel are critical to maximize adoption.”
Consider the “data” source
Understand the quality, completeness and timeliness of various data sources and the impact that has on in-trial monitoring. Because DCTs can involve the use of multiple data sources including wearables/sensors, electronic patient-reported outcomes (ePROs) and electronic health records (EHRs), integration of various data sources is complicated. As Robertson said, “Thinking about the limitations, quality, and value of individual data sources to ensure you are bringing the right combination of data together is really important. The value of bringing in different data is creating a more complete picture of the patients in the trial. When you incorporate real-world data, it is more representative of a patient’s health.”
DCTs represent advancements in clinical research and have the potential to improve access to clinical trials, but adoption is critical. Considering all the variables is critical to their success. When properly strategized and conducted, DCTs can help to bring needed drugs to market faster.