Jennifer’s career as a clinical data management and clinical development executive has given her unique insights into where the industry is headed. She thinks DCTs are TNBT (the next big thing).
A decentralized clinical trial (DCT) is a popular buzzword right now, but behind the buzz is the usual mix of noise and confusion. For example, a DCT doesn’t mean decentralizing everything. In fact, fully decentralized or virtual trials are relatively rare. Far more common is a hybrid approach that mixes elements of both on-site and remote capabilities. For example, a more realistic DCT study may feature electronic consent (e-consent), data collected directly from wearable devices, televisits and sample collection at a local pharmacy, while still requiring a portion of research data to be captured during specific visits to an investigator site.
Decentralizing aspects of the clinical trial is a natural evolution, with the caveat being that the COVID-19 pandemic helped accelerate that evolutionary process by several years. Bringing mobile and digital technologies into trial design represents a critical point in the continuum of clinical trial development, but it’s not an ultimate destination. Instead, the goal of decentralization should be to optimize and streamline clinical trials versus moving work around. That said, decentralization is not necessary for all types of research. For example, in the case where clinical trials involve hospitalized patients, centralized services remain the most efficient and effective means of management, and the ability to integrate data flows directly from EHRs/EMRs adds significantly more value than trying to decentralize aspects of the trial.
To date, DCT practices have had their widest adoption at the edges — that is, in the beginning and end stages of a trial. This is in part because DCT technology is especially adept at streamlining both the patient and data touchpoints that occur during a trial. In the future, we expect to see decentralized digital technologies play more of a role in optimizing the research process by actually eliminating workflow during the trial execution. In order to support this, however, these technologies will need to be flexible enough to adapt to a variety of trial needs.
The majority of solutions available to clinical trial developers are built with the mindset of “one solution, one system.” If you want to add or remove features within the system to accommodate a particular study design, it’s a complex process. When you try to incorporate DCT into these solutions, it can lead to significant data integration and transformation work for technology and data management teams as they look for ways to “plug in” and create direct data feeds for each new study.
When Merative built its clinical trial platform over 10 years ago, we knew that flexibility would be a critical component to successfully execute clinical research. As a result, we chose a plug-and-play feature design that would allow trial developers to easily customize the elements for each trial. For example, if a study requires remote data collection from digital devices or can benefit from turning on artificial intelligence to analyze medical coding data, those features can be simply activated as needed at the study level. In this way, you only pay for the features you need when you need them.
For DCT to evolve, the industry needs to move beyond the traditional solutions of the past, which were often standalone products customized for each customer and connected like plumbing. Likewise, the large price tags associated with these legacy solutions — including the high cost of switching — will also need to change. We believe the future lies in finding efficient and secure ways to bring in and leverage data so trials can function within a more plug-and-play research ecosystem. As part of this, you need intelligence-empowered solutions available out-of-the-box to streamline data management and trial execution. These must be nimble, cost-effective solutions that require less time to see a meaningful return on investment and can accommodate the evolving needs of the future.
The real value of decentralization isn’t about doing what you’re doing differently today, but expanding the definition of what you can do. DCTs can help reach patient populations where unmet needs exist, improve patient engagement with trial processes and even improve the provider’s engagement with the patient. Nurses, doctors and healthcare workers are increasingly feeling overwhelmed and limited in the amount of time that they can spend with their patients. The ability that decentralized technology affords to reach more patients more frequently while using less time to do it is, to me, the primary benefit of the DCT movement.
DCT is not the answer for everything. Its strength lies in giving clinical trial developers the opportunity to create more user-centric designs and do it better and faster. Providers do themselves a disservice when they think that DCT adoption requires a complete move to digital technologies. Even if you run all your clinical trials using a fully on-site model, you can benefit from incorporating DCT processes into your workflow right now. Because, ultimately, the goal of every trial is to test your patients, not test their patience.