Making clinical trials easier for patients by leveraging technology to reduce the burden of traveling to sites is undoubtedly a positive development. Bringing trials to the patient can not only expand the available pool of patients from which to recruit for a clinical trial, but it is also an essential step toward improving diversity in clinical trial populations.
Is “decentralized clinical trials” or DCTs, however, the best way to describe these types of trials? Does the term help patients, or even clinical research industry workers understand the benefits these trials bring to patients or the bottom line? This week, on his Research Confidential podcast, ProofPilot Chief of Strategy Joe Kim spoke to Chair and CEO of Centricity Research, Jeff Kingsley, about this and other topics, including Jeff’s passion for working in clinical research.
Jeff began by telling Joe how he got into clinical research. He first encountered the clinical research process while at medical school, where he read some of his first clinical trial protocols. Later, while working as a family medicine physician, Jeff became aware of his patients who could not afford their own co-pays. Some patients would even take their daily medications every other day to make them last longer, as they couldn’t afford to pay for the entire regimen.
Knowing that clinical research offered a way of delivering free healthcare to patients who need it, Jeff started a research company with a friend on a minimal budget and initially just as a side hustle. Within 6 months, however, Jeff had “fallen in love with” research - particularly the level of attention, respect, and time dedicated to patients during the clinical research process. Compared to the typically hurried interactions between doctors and patients in non-research medical settings - where, on average, a doctor will only see a patient for eight minutes - the contrast with research healthcare was stark. From that point, Jeff left his career in healthcare and moved full-time into research.
Recalling his first trial as a PI, Jeff told Joe how he took on a demanding, twice-daily IV infusion antibiotics study in really sick patients, with a staff of barely four people. Even working up to 16-hour days, though, he was buoyed by the satisfaction of providing free healthcare to patients.
Fast forward to today, and Jeff’s company - Centricity Research - has 43 offices in North America, with around 600 trials currently ongoing. Jeff explains that Centricity tends to run the more complex, phase I - III trials, across a broad range of therapeutic areas.
Digging a bit deeper into the current state of clinical research, Joe asked Jeff about the different technologies his sites have to use. Jeff confirmed that the sheer number of different systems his research staff uses across different trials is still daunting, despite some consolidation amongst clinical trial platforms over the years.
“You can't be good at knowing how to use 14 different platforms efficiently”
He makes the point that staff having to train on and become proficient at using - not to mention remembering usernames and passwords for - different tech platforms becomes so much harder the more platforms there are. The result is that too many different platforms can impact how well staff can use them. Instead of bringing improvements, excessive numbers of different technologies can decrease productivity and efficiency, especially when there are no clear integrated directions on when to access each. Fortunately, ProofPilot’s digital protocol platform solves this very issue for sites!
What to call DCTs?
Joe then explored why Jeff had declared to a room of clinical research executives at SCOPE 2022 why he said: “decentralized clinical trials is s stupid term.” Jeff felt the term isn’t helpful as it doesn’t capture the purpose or the interest in bringing trials to the patient. That is, it is not the “decentralization” that drives the drive to conduct trials in a more patient-centric way. Trials have been decentralized to an extent for 15 years or so.
“[the term ‘decentralized clinical trials’] doesn’t tell anyone why we're doing it, which is the critical thing. We're doing it to reach out to the patient, to go to them.”
The term “direct-to-patient trials” would communicate much more clearly and powerfully - to patients, to the industry - the whole reason for bringing research to the patient, i.e., to reduce patient burden, and open up access to clinical research by removing geographical barriers. Adding an ePRO and calling it a DCT dilutes the value and ROI of what can be a truly transformational set of tools.
Do DCTs add complexity?
Jeff’s view was that the actual protocols of DCTs are not necessarily more complex. Still, extra thought and special consideration are needed in DCTs on matters such as communication plans and workflows, as DCTs introduce a host of other actors not under the same chain of command. For example, a well-defined communication structure needs to be in place in DCTs to cover roles and responsibilities when staff is not physically on-site and, therefore, cannot coordinate activities easily. This could be a research nurse at a patient’s home who may need to report an SAE, but it’s a weekend or public holiday, and there is uncertainty over how to contact the PI or who will file the SAE paperwork. ProofPilot’s orchestration engine becomes a necessary foundational technology to coordinate disparate tech and clinicians in a DCT model.
While Jeff recognized that having more decentralized components can add complexity to trial activities, he was bullish about it. After all, the reason for making trials more patient-centric is to expand access to clinical research, which addresses the biggest challenge in trials - finding patients that meet the criteria for participation in studies.
“Anything we can do to remove barriers so that we can engage with more patients who meet criteria for research trials, is worth doing, even if it's hard.”
But how to manage contracting and payments when so many different players are involved - such as home health nurse providers, technology providers, shippers, and others? Jeff responded that whatever arrangement is reached between sponsors, sites, and the different providers, it is important to stay focussed on generating good quality data to change the future of healthcare. While this doesn’t answer the question directly, it does help to establish priorities of importance.
Ultimately, the amount paid by the sponsor should be commensurate with the work performed by a site. So while a site may do less in a specific DCT trial, it should open up the capacity to do more trials on the whole. The key is to be open and honest about hidden costs and expenses to help build trust between all parties, allowing contracting and budgeting to progress as quickly as possible, which is often the rate-limiting factor in study start-ups.. Breakdowns in the trust are a loss for sites, providers, patients, and sponsors, and therefore efforts (in contracting and budgeting) should focus on working together to achieve the common goal. Sadly, sites stop enrolling and conducting trials that, lose them money.
When Researchers Aren’t Behaving Like Researchers
Finally, Joe asked Jeff what drives him to continue his work in clinical research and what goals he still has in the field. Jeff replied that he is driven by a desire to revolutionize research. That is, he loves doing research and considers research in itself an honorable activity. However, what excites him is the opportunity to do research even better - for example, by investing in innovative technologies that bring incremental improvements. Jeff also commented on the irony that while research is itself the innovation arm of healthcare, clinical research tends to be slow to adopt innovations.
For example, Sponsors often adopt a new piece of technology on the back of a sales pitch, without ever testing it before going live, let alone performing a fair comparison to see if it leads to improved outcomes versus a traditional method. Instead, technology providers create marketing claims based on loose criteria with poor controls. Providers that present data and conclusions like this to an industry of actual researchers are always met with deserved skepticism. Let’s hope researchers and solutions providers encourage each other to measure operational innovations as rigorously as they would therapeutic innovations.