Adopting Decentralized Clinical Trial Approaches is More than Implementing Technology: 5 Potential Pitfalls
Decentralized clinical trials (DCTs) have many benefits. DCTs accelerate clinical trial recruitment and patient enrollment, improve patient diversity, and increase medical research participation while decreasing patient burden through more options and greater choice. A range of data sources can be leveraged—traditional clinical data, data from wearable sensors, and patient-reported outcomes—making the outcomes more relevant and the results more generalizable. Additionally, there is less burden on trial sites with more streamlined workflows.
For these reasons, decentralized clinical trials were utilized by a growing number of life sciences companies as a way to accelerate drug development and improve the patient experience even before the COVID-19 pandemic brought the world to a halt in 2020. The inability of patients to make it to trial sites because of the global pandemic hastened the adoption and popularity of DCTs and made them mainstream. But, without proper adoption, implementation, and execution, improved patient experience is not guaranteed.
When looking at adopting decentralized clinical trials, much of the focus is on decentralized technology design and implementation. While this is critical, there are several other key considerations to be aware of for successful DCT execution and improved trial site and patient experiences and adoption.
1. Whole System Approach to Decentralized Clinical Trial Study Design: Why Less Could Be More
Decentralized clinical trials are not “one design fits all”. The therapeutic area, type of intervention, patient population, and location can all influence the design. Many design options can be chosen including in-clinic vs. virtual trial (or a combination), study-specific labs vs. regular clinical care, inclusion of electronic health records, and embedded design.
“There’s a temptation to try everything,” says Holly Robertson, PhD, Director of Advisory Services at Medidata. “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.”
It is important to evaluate and streamline the strategies necessary to meet study objectives while avoiding potential complications. The technology selected should support the clinical trial design, rather than choosing a design that aligns with the technology. It’s also a good idea to consider the end-to-end experience since siloed development of trial components can lead to what Robertson calls a “Frankenstein” study that isn’t cohesive.
2. Patient Experience in Decentralized Clinical Trials
The patient experience is critical to the success of any trial, whether it’s a decentralized clinical trial, traditional, or hybrid. It is imperative to include patient partner groups as part of the clinical trial design and operational execution strategies. Study materials should be patient-friendly, engaging, and tailored to diverse patient populations. The patient-centric approach should be maintained throughout the trial, such as in using a patient portal to streamline patient participation.
Providing patients with options in how they participate can make choosing to join and stay in a study easier. While some flexibility can support patient retention, too much can lead to confusion and challenges in trial monitoring and quality, so it is important to strike the right balance.
“The engagement strategy is key,” Robertson says, “so patients are adhering to requirements, and incentivized to stay around.”
That strategy involves creating a community for patients, providing trial updates through alerts, notifications and newsletters, and providing reminders and scheduled touchpoints to maintain patient engagement in clinical trials while supporting patient retention.
3. Regulatory Adoption
The regulatory landscape is rapidly changing to adopt new clinical trial technologies while maintaining patient safety and data privacy. Keep in mind that some countries and regulatory agencies are more ready than others. It’s important to hold conversations early and often, providing clear messaging on strategy, decentralized technology, etc. to avoid delays.
4. Site Roles and Responsibilities: Strategies to Support Change Management
Patients may be more ready to adopt DCTs than trial sites, so it is important to invest in site engagement and training to support adoption of new strategies and technologies. Understand that sites may have concerns with maintaining oversight due to virtualization as well as the compensation model in leaner trials. For these reasons, site representatives should be partners in the design and operational execution of trials as well.
“Sites may be hesitant to adopt new engagement models,” Robertson says. “Education and training for study personnel are critical to maximize adoption.” This includes how to leverage methods, such as registries and computable phenotypes for rapid identification, and high-volume recruitment and enrollment strategies. Additionally, the definition of principal investigator (PI) and site may be different in a DCT. For example, an entire department or healthcare system may be involved, rather than a single PI, so engagement and support of the wider clinical care team are essential.
While DCTs may reduce or eliminate in-person study visits, patients often want to remain close to a clinician even if they see them less. “Patients still want to feel clinicians care about them and support their participation in a clinical trial,” advises Robertson. Utilizing video visits can aid in this relationship building.
5. Consider the “Data” Source
It is important to understand the quality, completeness, and timeliness of various data sources and the impact that has on in-trial monitoring. DCTs often involve the use of multiple data sources including wearables and sensors, electronic patient-reported outcomes (ePROs), and electronic health records (EHRs). Integration of various data sources is complicated, especially when using them for insights during trial conduct.
“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,” Robertson says. “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.” Data collection through virtual visits should also focus on adherence and safety monitoring.
When designing a data strategy based on multiple clinical trial data sources, it’s important to keep in mind the characteristics of each data source and to consider how the alignment of the data sources impacts patient insights and safety monitoring. Having a data strategy that incorporates multiple data sources provides the most complete view of patient insights, which will always lead to better trial outcomes.
Decentralized clinical trials represent advancements in clinical research and have the potential to improve access to trials, allowing for improvements in patient recruitment, retention, and diversity, but adoption is key. Choosing the right technology partner and having a well-thought-out and executed strategy will allow life science companies to capitalize on the potential of DCTs, ultimately bringing new drugs, vaccines, and devices to market faster.