The benefits of DCT components in small drug trials
Small drug trials can face numerous challenges in study design, site coordination, recruitment and retention, compliance, and more. In many cases, the incorporation of decentralized trial technology and service components can help sponsors design and execute a successful trial collecting all desired data points, minimizing patient burden, expanding access and diversity, and ensuring the study is running as efficiently as possible while remaining cost-effective.
Take a look at how decentralized components can be leveraged to directly address challenges that may arise in the execution of small drug trials:
In 2018, the FDA released a new strategic framework to advance the use of real-world evidence to support the development of drugs. In this statement, it is noted that this type of data includes capturing “the experience of physicians and patients with the actual use of new treatments in practice.” This can be done seamlessly through the use of decentralized trial components such as eClinical platforms that allow for trials to take place in their intended settings such as local doctors' offices, clinics, or patients’ homes.
A 2022 study looking into the role of decentralized clinical trials in cancer drug development stated that decentralized clinical trials “focus on patient-centricity, rather than site-centricity, giving patients considerably more flexibility in the way they participate. DCTs enable remote data and sample collection, including from the patient's home or other convenient locations in order to reduce burden on patients and their caregivers. DCTs also have the potential to partially bridge the gap between the current gold standard of randomized controlled trials (RCTs) with their rigid rules, central laboratories, and physician-verified data on the one hand, and a more “real-world” paradigm of flexibility, local laboratories, patient-supplied data via wearables and mobile applications (apps) on the other.” This article, along with many others, highlights the ways in which DCTs can advance clinical research by minimizing burden, optimizing data collection, and expanding patient access yet ensuring that high quality data is being captured from real-world settings.
Increased diversity and inclusion
A recent article put forth by the FDA identified numerous barriers to participating in clinical trials among racial and ethnic groups which include: “mistrust of the clinical research system due to historical abuses,[...] inadequate recruitment and retention efforts, frequency of study visits, time and resource constraints for participants, transportation and participation conflicting with caregiver or family responsibilities [...], language and cultural differences, health literacy, religion, limited access within the health care system and a lack of awareness and knowledge about what a clinical trial.” Decentralized clinical trials are not ‘all-or-nothing.’ Not all studies will use every DCT component a vendor may offer, sponsors can choose the components best suited to run their trial effectively while addressing any specific concerns and expanding patient access and diversity.
Some decentralized trial models allow patients to complete all necessary in-person trial components at local care clinics rather than research centers giving patients the opportunity to receive care from local facilities they may already trust or have a relationship with while also mitigating the time and resources needed for patients to travel long distances.
Strategic direct-to-patient recruitment and enrollment efforts allow sponsors to reach diverse patient populations and can directly target underrepresented groups to inform them of a study they may qualify for and allow them to enroll and prescreen in a convenient manner.
eClinical software platforms and universal mobile apps allow patients to have optionality when it comes to which device they participate with while also supporting different languages and providing information in a way that is easy to understand. eClinical platforms also help patients remain engaged and retained throughout a study with reminders, scheduling prompts, checklists, etc. while minimizing patient burden and unnecessary in-person components.
Reduced patient burden
A well-known benefit of DCTs is reduced patient burden, but what is not as easily understood is the ways in which DCTs can directly address concerns about patient/caregiver burdens at specific points in a trial. For example, an important aspect of drug trials is medication compliance and accurate adherence tracking. In a decentralized trial, sponsors can use tools on an eClinical platform that not only track patient compliance but also send patient reminders, checklists, scheduling prompts, etc. to keep patients engaged and completing study activities in a way that is convenient for them.
Another instance where decentralized trial components can be used in practical settings to reduce burden is the use of mobile phlebotomists/nurses for patent sample collections. Allowing patients to complete all necessary steps of the trial without having to go out of their way to travel to research sites makes participating in clinical research as convenient and easy for patients as possible while still running an efficient and cost-effective trial.
To learn more about how a small drug trial can leverage different DCT components take a look at Curebase’s products and services here.