Clinical-trial sponsors are constantly looking to make clinical trials quicker and to improve both the patients' and doctors' experience. Decentralized clinical trials (DCTs) are a crucial tool for this mission. This involves bringing a growing proportion of the activities of a trial to the patient, instead of using the standard model of patients going to the clinical trial site.
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Decentralized clinical trials are trials carried out through telemedicine, mobile technologies, and/or mobile/local healthcare providers (HCPs) that aren't restricted by the geographic limitations that impact traditional trials.
Standard clinical trials can be inefficient and expensive¹. They create a substantial participant burden via travel and other logistical demands. The use of new methodologies and technologies to promote a decentralized method has the potential to improve clinical trial efficiency.
There's a general recognition that decentralized clinical trials benefit patients, caregivers, and the industry in a variety of ways, including:
A DCT approach allows the participants of the trial to participate in clinical research from anywhere. The activities of this clinical research are better integrated into their everyday routine.
DCT methods may reduce the burden on participants (i.e. time loss and travel costs), which can improve retention and facilitate specific research that might be burdensome under standard trial constructs.
DCT methods may improve patient engagement. Using technology, including online patient diaries, appointment reminders to smartphones, electronic access to research staff, and gathering of data through wearable devices, increases accessibility, engagement, and consequently, retention.
According to a study², retention and recruitment continue to be the main challenges when it comes to randomized clinical trials (RCTs). In fact, between 50% and 60% don't meet their initial recruitment goals, or face substantial delays.
This study explains that over the previous 10 years, clinical trial design complexity has substantially increased in terms of the number of planned onsite visits and distinct procedures. This negatively affects the willingness of a participant to even enroll in a trial since it demands their time and interrupts their daily activities.
Decentralized clinical trials can leverage "virtual" tools, like:
Wearable medical devices
Direct delivery of study materials and drugs to patients' homes
Patient-driven virtual health care interfaces
In a fully DCT³, participant recruitment, study drug delivery and administration, and acquisition of trial results data all proceed without the need for in-person contact between the patient/participant and the study team.
DCTs do come with certain challenges.
A huge advantage to centralized studies, when compared with DCTs, is comparatively easy drug management and distribution. In centralized studies, the study drugs are delivered to the trial center which centrally manages and maintains them.
DCTs, on the other hand, require shipping the drugs to multiple coordinating sites, which includes possibly directly to the homes of the patients. In order for this to happen, there needs to be an assurance of appropriate storage facilities and drug stability in the patients' homes, along with measures that help:
Prevent unauthorized access
Temperature tracking to assure proper drug storage
Methods to detect tampering
Communication between the drug source and the storage system for timely refills and to prevent interruptions in the study
Dosing diaries to record drug administration
Furthermore, local laws which impact state-specific allowable drug dispensing parameters must be addressed. There's a potentially greater risk in clinical trials due to complex decentralized drug management and shipping.
Advances in technology are core components in decentralized clinical trials, but they're also a primary challenge to adopting the DCT study design. For example, wearable biometric devices are still in the early development phases, and before they're generally accepted in regulatory decisions, clinical validation is required.
Even the devices' operation depends on the availability of:
Internet infrastructure (i.e. remote location cellular towers or connectivity to hard-wired internet in houses without it)
Another potential problem is protecting the privacy of patients' stored data on connected devices as well as the data transmitted through the connection services.
To store private patient data and transmit it in a DCT, there must be reliable cybersecurity systems in place. Most traditional trials use centrally managed and firewalled local data systems. But in numerous studies, participants/patients will interact with a number of health care providers through the use of various electronic health record systems (EHRs).
This creates a challenge for central data amalgamation of various EHRs which frequently experience problems with efficient communication.
DCT settings are well-accepted by patients and operationally feasible. They allow for enhanced patient access and faster recruitment.
From the perspective of the patient/participant, since there are limited or no required onsite visits in a decentralized setting, it reduces or eliminates the geographical barriers to participation and the impact on daily routine. In a traditional clinical trial setting, sites are frequently clustered in urban locations.
With decentralization, however, trials can expand their reach to participants/patients with poor access to healthcare, like those patients who have limited mobility or live in rural locations. These populations are generally underrepresented in research and the DCT site approach would allow a larger number of patients to gain access to new advanced medications.
From the perspective of a sponsor, with increased convenience of participation and reduced transportation barriers, the recruitment rate is expected to be quicker in the DCT setting than in the traditional site model.
Additionally, the supplying of a more convenient trial experience might enhance patient compliance, retention, and improve adherence to protocol requirements.
For numerous pharmaceutical organizations, DCTs have rapidly become a strategic priority. Patients' increased use of digital healthcare, like digital pharmacies and telemedicine, has improved expectations of their experience in clinical trials, which isn't expected to regress moving forward.
As decentralized clinical trials become more common, they'll raise the bar for patient data collection and patient experience. They provide the possibility to fundamentally change how clinical research is done.