The Risks and Rewards of Decentralized Clinical Trials
By Dario Lirio, Senior Director, LifeSphere Clinical at ArisGlobal
For years, researchers have been moving towards decentralized clinical trials (DCTs), and in a matter of months, COVID-19 changed the trajectory. Practically overnight the risk-benefit profile for patients involved in clinical trials changed, and at that time in mostly unknown ways. Which patients were at most risk? What about the risks to patients if they couldn’t continue receiving study therapies?
Clinical operations teams and investigator sites around the world rose to the challenge and worked quickly to deploy new tactics to serve their study participants. The resulting reward is that the DCT, which can be leveraged smartly to reduce participant burden and improve recruitment and retention, is now becoming more widely adopted in design considerations.
But rewards bring about new risks and challenges, and DCT creates new concerns for monitoring participant safety. Depending on the technology utilized, the burden of review on researchers and data quality assurance can make it difficult to streamline results. The best solutions offer auto-query and alert options to keep study teams informed in near real time. Open text entries can also present unique challenges for ongoing monitoring, but innovations in R&D technology mitigate these risks.
DCTs completely revise historical trial processes by executing trials through telemedicine and mobile or local health care providers. Although COVID increased the need for DCTs, 75% of the industry report very little use of decentralized and virtual trials. There needs to be a paradigm shift.
Reaping the Rewards
For DCTs to be successful, there has to be an emphasis on collaboration and communication between the participant and investigator. When I think of the rewards stemming from decentralized trials, I think of patient convenience, diversity, improved retention, faster recruitment, and real-world data collection.
DCTs provide a patient-centric approach, which allows for fewer clinic visits and reduces the burden upon participants. Traditional clinical trials require participants to visit a site every time the collection of data is needed. This means they may have to drive far distances or take time off work. DCTs give participants an increase in personalized care which is especially important for participants who may have an illness since oftentimes they want to receive the newest treatment and attention from the clinical trial staff.
The disparity of diverse representation has been troublesome since the beginning of clinical trials and fortunately, DCTs can combat the lack of diversity and inclusion making it easier for people to join these trials and ensure treatments are effective for a wide range of patients. DCTs even add a mobile point of care to reach participants too far from sites to partake in visits and alleviates some of the recruitment challenges as they are easily accessible.
DCTs also allow real-world data to be collected in regards to a patient lifestyle instead of in an artificial clinical setting. This is beneficial since it results in a better chance of improving patient outcomes primarily through the real-world evidence (RWE) it produces.
Weighing the Risks
While the rewards and opportunities for DCTs are plentiful, they also bring about risks and challenges to sponsors and service providers. DCTs must navigate site burden, data quality, technology complexities, and patient safety.
New technologies bring potential learning curves to those implementing the study. DCTs may require sites to learn new systems or change how they operate. Sites are already working on tight margins, and a burden overload can cause a site to get pushed out of the industry because it’s not sustainable.
For data quality, there’s a concern that we may be collecting more data than needed. Sites have to review this data in real-time to make sure patients are safe and that they’re raising any potential query that may be overwhelming and difficult to manage. Selecting the right clinical trial management solution that is aware of, and able to address, these concerns is crucial.
Patient safety is always at the forefront of any trial, clinical or decentralized. A clinical trial is already an unfamiliar experience for patients — throw in technology for DCTs, and it can become burdensome. Comfort levels of technology vary for patients, so a patient-centric design is essential for any study. To navigate this risk of technology complexity as it relates to patient safety, the design should include training and support, easily accessible user interfaces, and open communication between the patient and the site or investigator.
The key for a successful DCT is to ensure methods serve the study adequately so that the focus always remains on helping patients and advancing research. It’s a new way of looking at our clinical trials — keep the best of it and learn from the rest.
About Dario Lirio
Dario Lirio is the Senior Director, LifeSphere Clinical at ArisGlobal where he applies his unique 18 years of experience in the enterprise cloud services industry working with Pharmaceutical, Biotech, large banking and financial institution customers to successfully design, develop, and deploy business solutions.