Over the last two years, there has been a striking increase in the number of decentralized clinical trials (DCTs) conducted. This is largely due to advancements in digital health and telehealth spurred by the COVID-19 pandemic. Although the DCT industry is set to expand by 10% annually, there are concerns that transitioning from in-person visits at hospitals or research sites could lead to significant challenges, particularly when integrating new technologies and data workflows.
With this in mind, we wonder if DCTs are a short-lived reaction to the pandemic or if they will be here to stay. This article will try to answer these questions by exploring the power and potential of DCTs, as well as unpacking the challenges that may need to be overcome.
COVID-19 and the Modernization of Clinical Trials
Conventional clinical trials require participants to attend scheduled visits at clinical research sites, such as hospitals or specialized clinics. DCTs allow trial participants to have digital check-ins instead of in-person visits. This can be done in the individual’s home environment.
Decentralized clinical trials can also involve home visits, direct-to-patient drug delivery, and the use of local healthcare facilities.
The concept of conducting clinical trials without site visits is not new: mail-based randomized trials and phone-call follow-ups have been conducted since the 1980s. The REMOTE trial, conducted in 2011, was the first entirely web-based trial.
Preserving Trial Continuity in Challenging Times
Yet it was the pandemic that generated the real shift towards DCTs. As access to trial sites decreased by 80% within the first few months of the pandemic, sponsors had to quickly make sure trials were continued, while maintaining participant retention and data integrity. As a result, the number of DCTs worldwide more than doubled between 2020 and 2022.
The pharmaceutical industry has noticed this shift. As McKinsey reported in December 2019, 38% of pharma and contract-research organizations (CROs) expected DCTs to form a major part of their portfolios. A year later, 2020, and that percentage jumped to 100%.
Clinical Trials: The Burden of Enrolment
Clinical trials are a necessary pathway for bringing new drugs to market. Typically, trials cost millions of dollars and take an average of 7.5 years to complete. Approximately 30-40% of that time is taken up by participant enrolment.
Despite having a large number of participants at the beginning of a trial, it is not a guarantee of success.
If a trial has a high drop-out rate, one way to counteract that is by enrolling more trial participants than necessary. However, this strategy can significantly increase costs.
Patients as the Focus of Decentralized Clinical Trials
One appeal of DCTs is their convenience and simplicity for participants. In the US, many potential trial participants live over two hours from a clinical research site. Reducing travel times can help increase participation in a trial, as well as improve participant diversity, leading to more reliable results.
Decentralizing some trial components, such as using a smartphone to monitor heart rate or having patients bring their own devices to a health clinic, boosts trial recruitment and retention rates.
Studies have demonstrated that involving participants in data collection improves engagement in the trial. Self-reporting and getting direct feedback on results makes participants feel they are the critical factor in the success of the trial, and this patient-centricity provides a better patient experience.
Digital Technology Opening Doors for Clinical Trials
Digital technology has facilitated the transformation of clinical trials in many ways, mainly through teleconferences with healthcare providers (HCPs), web-based questionnaires, online reporting tools such as electronic Clinical Outcome Assessments (eCOA) or electronic Patient Reported Outcomes (ePROs), and real-time patient monitoring using sensors and wearables.
The pandemic may have forced the health industry to adopt new technologies out of necessity, but it has also brought forth a multitude of digital solutions, apps, and platforms.
Digital solutions that are easy to use can collect more data than those specified in clinical trials, often in real time. As the data is delivered directly from the trial participant, data verification steps can be simplified.
Electronic consent forms (or eConsent) for trial participation mean that trial participants can become familiar with the processes and expectations within the comfort of their home and at their own pace. No need to read paper documents on-site. Adding educational content like short videos to eConsent was found to increase participant enrolment, especially among disadvantaged groups.
Challenges in Implementing Decentralized Clinical Trials
The digital divide is a major limitation of decentralized clinical trials. This divide refers to the gap between those who have access to the internet and those who don’t. The divide makes it difficult for segments of the population to participate in clinical trials, particularly older adults and people who live in rural communities.
Addressing this problem is necessary to ensure clinical trials don’t exclude whole groups of potential participants. One option is to give participants a choice of whether they want to be part of a decentralized arm or a conventional arm in a study.
A survey of 252 biopharmaceutical companies, CROs, and medical device companies involved in clinical trials, revealed that the main hurdles DCTs have to overcome refer to the data itself.
Data ownership and authentication, integrating data collection with data management, merging technologies with platforms used in clinical trials, and data reliability are key to ensuring the safety and integrity of the decentralized clinical trial, as well as streamlining the clinical trial for participants, investigators, and regulators.
5 Things to Consider When Designing a Decentralized Clinical Trial
1. Choosing which trial components should be decentralized
When designing a decentralized clinical trial, it is important to identify where decentralization can add the most value to the process. Are there areas where patient burden can be minimized? Would the use of digital technology, home visits, or implementation of a delivery system for medication or lab samples make a difference? Will these new measures improve communication with participants?
2. Accessible technology
Results from DCTs have shown that simple, easy-to-use technology is fundamental to the overall participant experience.
The main reasons for people dropping out of digital clinical trials are unrealistic expectations and immature technology. Therefore, it is essential to thoroughly test hardware and software before a trial begins.
3. Technology adapted to the patient
It’s imperative that DCTs are tailored to specific patient groups. One example is the participation of older adults, who may lack confidence or the experience with digital technology.
Older participants run the risk of becoming frustrated with text being too small, or worrying about breaking the device. Simplifying interfaces through larger text or options for magnification make the technology more accessible.
4. Building a compliance framework
As with all digital health solutions, regulatory compliance, and technical and clinical validation of digital technology used in DCTs serve as the mainstay for all stakeholders involved in clinical trials. This builds trust in the technology and its ability to produce convincing trial results.
During the pandemic, the FDA issued general guidance for industry, investigators, and institutional review boards on how to safely conduct clinical trials under pandemic conditions.
The opportunity to uphold these recommendations for post-pandemic use in DCTs has not been lost.
Regulators are working to create standards for using digital technologies in decentralized clinical trials. The FDA issued draft guidance on this in December 2021.
5. The step-by-step approach
McKinsey’s report on DCTs notes that most trials will not be fully decentralized for the time being. A hybrid approach to decentralization could be the new norm for now, with sponsors incorporating those elements of decentralization that best fit trial protocols and endpoints.
DCTs go Hand in Hand With Digital Therapeutics
Decentralized clinical trials will only progress with mature, reliable digital technology in place. Pharmaceutical companies are partnering with successful digital therapeutic platforms to maintain their standards of quality and competitiveness.
There are DTx solutions that have been clinically validated and can be customized for each patient’s care journey. These solutions can help digitize clinical trials.
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