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How the decentralised trial model could be a catalyst for global health equity
03 Apr, 20235 MinutesThe life sciences industry has seen a surge in the adoption of decentralised clinical trial...

The life sciences industry has seen a surge in the
adoption of decentralised clinical trials (DCTs) over the past few years.
This innovative approach to clinical research has demonstrated its potential to
not only improve the efficiency of the trial process but also to promote health
equity across the globe.
The cutting-edge trial design is reshaping the way clinical
research is conducted by leveraging digital technology and remote patient
monitoring to bring clinical trials to the patients, rather than the patients
to the trials. DCTs are designed to reduce the burden on trial participants by
offering greater flexibility in terms of time, location, and participation
requirements, and also helps sponsors and researchers cut costs compared to
traditional, site-centric trials. This patient-centric approach has been shown
to improve
patient engagement and retention in clinical trials.
The adoption of DCTs has been accelerated by pandemic, which
highlighted the need for a more agile and adaptable clinical research model.
The rapid development and deployment of COVID-19 vaccines demonstrated the
benefits of decentralised clinical trials, including faster
patient recruitment and a more diverse patient population.
The decentralised model in action
One notable example of a successful decentralised clinical
trial that made use of wearables and remote monitoring technology is the Apple
Heart Study, a collaboration between Apple and Stanford University. This
study used the Apple Watch to collect data on participants' heart rhythms,
enabling researchers to identify irregular heartbeats and atrial fibrillation
remotely.
Anybody over the eligibility age of 22 within the United
States that owned an Apple Watch could take part in the study, and over 400,000
participants took part in total. The exercise demonstrated the potential for
decentralised clinical trials to reach large and diverse populations,
and showcased the effectiveness of remote monitoring technology.
The decentralised trial design harks back over a decade to a
fully remote trial conducted
by Pfizer. It was the first-ever completely remote, internet-based clinical
trial, evaluating the safety and efficacy of an overactive bladder medication.
The trial used mobile technology to screen, enroll, and monitor participants,
eliminating the need for in-person visits.
How decentralised clinical trials support health equity
Access to underserved populations
One of the most significant advantages of decentralised
clinical trials is their potential to reach underserved populations.
Traditional clinical trials often struggle
to include participants from rural or remote areas, as well as minority and
socioeconomically disadvantaged populations. DCTs, on the other hand, have the
potential to remove geographic barriers and logistical challenges, providing
access to clinical trials for patients who may have otherwise been excluded.
Diverse patient populations
By increasing access to clinical trials for underserved
populations, DCTs can help to ensure that the trial results are more
representative of the broader population, leading to more generalisable
findings and better-targeted
treatments. In addition, a more diverse patient population can help
identify potential disparities in treatment efficacy and safety among different
demographic groups, ultimately leading to better healthcare outcomes for all.
Patient-centric design
By design, decentralised clinical trials prioritise patient
convenience and comfort by reducing the need for in-person visits, which can be
particularly beneficial for those with limited mobility or transportation
options. By offering remote monitoring and telemedicine options, DCTs can
help to reduce the burden on patients and their families, leading to higher
levels of patient engagement and retention.
Cost savings
DCTs can lead to significant
cost savings for both trial sponsors and patients. For trial sponsors, the
use of digital technology and remote monitoring can help to reduce the
operational costs associated with traditional, site-based trials. For
patients, participation in a decentralised trial can eliminate the need for
travel and accommodation expenses, making clinical trials more accessible and
affordable.
Building trust and empowering communities
Trust is considered a critical
factor in the success of decentralised clinical trials. By actively
engaging with patients and their communities, trial sponsors can build trust
and increase participation rates. This is especially important for minority and
underserved populations, who have historically been underrepresented in
clinical research. Establishing partnerships with local healthcare providers
and community organisations can help to foster
a sense of ownership and empowerment among patients, promoting health
equity at the grassroots level.
Challenges and considerations
While decentralised clinical trials offer numerous benefits
for promoting health equity, they are not without challenges. Data privacy and
security concerns are paramount, as the use of digital technology and remote
monitoring can potentially expose sensitive
patient information. Ensuring that the data collected during DCTs is secure
and protected should be a top priority for trial sponsors and researchers.
Additionally, while DCTs can improve access to clinical
trials for underserved populations, there is a risk of exacerbating existing
digital divides if adequate efforts are not made to address disparities in access
to technology and digital literacy. Trial sponsors should consider
providing support and resources to patients who may lack the necessary
technology or skills to participate in a decentralised trial, to ensure that
the benefits of DCTs are accessible to all.
Decentralised clinical trials have the potential to
transform the landscape of clinical research and promote global health equity.
By increasing access to clinical trials for underserved populations, fostering
diverse patient populations, and prioritising patient-centric design, DCTs can
help to bridge the gap in healthcare equity worldwide. Despite the challenges
associated with data privacy and the digital divide, the benefits of
decentralised clinical trials in terms of cost savings, trust-building, and patient
empowerment make them a promising tool in the quest for health equity.
Tim Lobley is a dedicated and experienced recruitment consultant
specialising in clinical operations within the life sciences sector. For
support in staffing your upcoming trial, reach out to him on LinkedIn or get in touch with us here.