For the past few years, sponsors and CROs have moved steadily towards decentralized clinical trials. These shifts apply new approaches and technologies to clinical trials with the goal of reducing or eliminating the need for subjects to physically visit clinical research sites.
For example, instead of requiring regularly scheduled site visits, decentralized trials rely on having treatments or medications administered by the participant or a trained professional at the subject’s home or a local healthcare facility contracted by the sponsor or CRO. There are also several emerging technologies at play to support this approach. They range from simple Bluetooth blood pressure cuffs to smart watches that monitor your heart and activity rate, to devices that can autonomously measure blood glucose levels and send the data remotely. These technologies will help eliminate the need for patients to have to travel to a site to get this information to their medical team. Advances in technology that allow for this remote data collection provide a wealth of insight that simply isn’t available in a traditional trial. This additional wealth of data can prove essential in helping study teams make decisions earlier to positively impact overall clinical trial timelines.
Before COVID-19, most companies treated decentralized trials as pilots or proofs-of-concept. They may have added some decentralized components to traditional trials, or even in a few instances undertaken trials that were largely decentralized; however, dipping into this approach was largely experimental. With established procedures providing a level of comfort and familiarity – and regulatory acceptance – there was no sense of urgency in making decentralized trials more mainstream.
The pandemic created huge challenges for conducting traditional clinical trials, and with the urgency surrounding COVID-19 vaccines and treatments, it highlighted the need for, and accelerated the move to, decentralized trials.
Now, nearly a year into this health crisis, the industry attitude toward decentralized trials has changed.
According to a recent survey of 252 clinical research professionals from around the globe conducted by Informa Engage on behalf of Oracle, 76% of clinical trial teams say they have sped up the use of decentralized trials methods in the past year. It’s reasonable to expect some of these trial methods to remain.
Instead, sponsors will employ more and more technology for remote data collection, and adopt new technology platforms to design and manage decentralized trials, while also employing advanced techniques to analyze all the resulting data.
At the same time, as sponsors make the transition, they are likely to encounter some challenges along the way. For instance, having to make changes to systems and processes so they can handle the increased volume of data that decentralized trials generate and the novel data sources and formats that decentralized clinical trials bring. They also will have to learn to work closely with regulatory agencies that, despite broadly encouraging these new approaches, have yet to update mountains of regulations that are often unclear when it comes to new trial components, or simply don’t address them at all.
Why Decentralization Meets Today’s Clinical Trial Needs
The transformation of clinical trials meets two growing needs in the life sciences industry.
The first is supporting today’s patient-centric approach to healthcare, in general, and clinical trials, in particular. It was already becoming harder to find and enroll patients in trials, both for large-scale trials (like those now underway for COVID-19 vaccines) or those focused on rare diseases or “precision” medicine treatments, where the pool of potential participants is quite small. Sponsors have also come to recognize the need to enroll a more diverse patient population, representing a range of ethnic groups as well as ages and genders, as various therapies can have different results or adverse effects in some groups.
Thus, it became imperative to figure out a way to make trials accessible to people living too far from research centers for travel to be practical, or to people with cancer or other conditions for whom travel is difficult, uncomfortable, or impossible. Alternatives such as telemedicine for patient interactions with clinicians, visiting home nurses to administer medications or collect vital signs, and tablets for patient diaries became attractive solutions. These and other approaches that enable patients to participate remotely in clinical trials improve patient recruitment reach for sponsors, while also improving the patience experience – and there’s no going back. The aforementioned Informa Engage survey found that 64% of respondents have adopted patient-facing technologies or an alternative to in-clinic visits – a number that’s growing.
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The second need is for sponsors and investigators to have a richer and more complete picture of patients than is possible in a traditional clinical trial. Additional data can help identify potential problems much earlier, including patient safety issues, so study teams can make decisions and protocol changes sooner, for the benefit of all involved. These new data sources – both from direct-from-patient and from external databases such are EHRs – can provide insights around design, efficacy, and even additional indications that could be explored in later trials.
Some of the most significant sources of new data are mHealth devices that collect data from patients remotely, often automatically. Patient-worn sensors are available to measure everything from blood pressure and heart rhythms to activity levels and breathing. The data these devices generate can be collected, recorded, and processed by the site team.
The popularity of this aspect of decentralized trials is notable. Some two-thirds of those surveyed have implemented remote data collection in their trials – with the bulk coming from patient apps, ePRO, and wearable devices. More than half the respondents reported they use, or will introduce, wearable devices within 18 months.
COVID-19 Acceleration and Challenges
The global pandemic response not only shut businesses and led to stay-at-home mandates, but also put immense pressure on hospitals, clinics, and other healthcare facilities. Hospitals canceled elective surgeries and discouraged all but emergency treatment as much of the available staff were focused on responding to COVID-19 patients. Finding clinicians to take on clinical research became more difficult, forcing many sponsors to rely on a growing arsenal of decentralized trial components to support active trials to avoid shutting down trials altogether.
At the same time, the urgency to develop COVID-19 vaccines taxed clinicians and other trial professionals. Work that normally took years was compressed into months. This pace is simply not sustainable over the long-term. This has further highlighted the need to alleviate some of this burden, while speeding discoveries, with technology.
Moving ahead, this shift can include using a unified eClinical platform to maintain a single data set that feeds a variety of functions. In such an environment, studies are only built once, data is only entered one time, and everything is available in one place. Staff no longer need to waste time entering data into multiple systems, which not only reduces the risk of human error, but frees them to focus on work that is more important.
These unified platforms also are capable of harmonizing significantly increasing volumes of data from patient-worn sensors and other sources. Almost half the respondents in the survey reported that effectively tracking all that data is one of their biggest concerns with decentralized trials. A unified platform brings all that data together into a coherent view and across the different functions of the trial – again, streamlining operations and enabling staff to focus on high-value tasks.
It is important to note a key challenge with these new data sources, which is the fact that the amount of data generated is far more information than humans can process, and it is also much more complex. Luckily, great strides in the areas of AI and machine learning have been applied to automate many data-heavy processes to lessen the pressure. AI and machine learning have two massive advantages over a people-only approach – they can process data faster and they can identify patterns and trends that humans can’t see. This will ideally lead to a more accurate and detailed view of how patients are responding in trials – which can lead to better treatments in the end.
In fact, as more companies lean into decentralized trials, and as the pace of trials and the amount of data that needs to be analyzed continues to increase, AI and machine learnings will emerge as the preferred way to process this data efficiently and draw valuable insight.
Regulatory Changes
Technology may be advancing quickly to accommodate decentralized trials, but there remains one crucial element that hasn’t kept pace: regulations. Complex, voluminous, and written for traditional in-clinic trials, the regulations will need to adapt to the ways in which trials are changing, while protecting the interests of patients.
The ability for study teams to adopt many new technologies during the pandemic and obtain approvals were enabled by the willingness of regulators to be flexible in the face of this unique situation. Regulators moved with speed along with industry stakeholders, to chart a path to accelerate COVID-19 vaccines and treatment clinical trials in a safe manner. Yet, for all the effort, the survey showed that half the respondents feel that “regulatory issues are holding them back” from developing trials that have more virtual elements.
And, while that flexibility is likely to continue in 2021 and beyond, as regulators recognize the value of decentralization, it’s not likely they will move quite as quickly post the pandemic.
At the same time, the past year yielded some insights on how to create better regulations around decentralized trials, so a deliberate effort to create new or revised regulations covering decentralized trials methods may result in a better long-term direction. In addition, as the industry itself develops more data around decentralized trials and can present that to regulators, it will demonstrate that regulations can be revised to accommodate these new approaches.
Looking Beyond the Pandemic
COVID-19 put enormous pressure on the entire healthcare system and those organizations running clinical trials, but at the same time, provided the impetus for moving at least some aspects of decentralized trials out of pilots and into the mainstream. The experience has shown the benefits of the approach, and few sponsors or CROs are considering turning back the clock.
Technologies that support decentralized trials also continue to improve, thanks to both the experience and knowledge of long-established players and the competitive pressure from new entrants. The changing focus in biotech toward precision medicine and treating rare diseases will also make decentralized trials more valuable in the future and drive their adoption. Moreover, regulators recognize the need to establish rules that will streamline these trials while still protecting the public.
At the same time, not all patients are alike, and companies will likely be looking for ways to design trials that offer options that meet a wide range of needs. The more patient-centric sponsors and CROs become, the more likely they will be to conduct successful trials and bring innovative new treatments to patients.