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.

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