Take the hybrid road to bring clinical trials to patients

As the landscape of clinical trials evolves, decentralised clinical trials (DCTs) have emerged to put patients at the centre of the research process.

The COVID-19 pandemic was a major catalyst for this abrupt shift in healthcare and increased reliance on DCTs, as patient care pivoted from only in-person care to the adoption of mobile and digital health technologies. The demands of treating patients and maintaining staff to deliver quality care reinforced the need for digital health solutions that are now mainstream.

Investigators leading clinical trials faced similar challenges. Contract research organisations (CROs) expanded participant populations with a decentralised approach that reduced in-person requirements and turned to internet-based access, televisits, remote patient monitoring with wearable devices, and other digital solutions.

This article discusses three crucial components of clinical trials: the differences between traditional clinical trials and DCTs, recruitment of a diverse study population, and the benefits of adopting a hybrid approach to clinical trials.

Differences between traditional and decentralised clinical trials

Traditional clinical trials typically leverage “brick and mortar” study site(s), serving as the epicentre of clinical development within a region or geographic location. The designated investigator team conducts the required study visits, tests, and evaluations in person. They rely on the option to conduct tests at satellite facilities or by direct interaction with the patients who report specific outcomes to the investigator team.

Decentralised clinical trials bring specific components of the trial to the patient with remote access and reporting technologies. While completely virtual or fully decentralised clinical trials are rare, the hybrid approach represents a best-in-class approach with a mix of in-person and virtual participation solutions. A hybrid DCT design may include electronic consent (eConsent), data capture from wearable devices, televisits, and sample collection at a local pharmacy. Investigators may also collect specific research data during scheduled in-person visits at the trial site and retain key regulatory responsibilities, in order to maintain the quality and compliance of the research study.

Challenges of recruiting a diverse patient population

Clinical trial teams faced waning participation during the onset of the pandemic in 2020, as reported in a 2021 article in Bioanalysis. The design of clinical trials required participants to travel multiple times to and from specified sites, sometimes hours away, to provide data and participate in other research requirements.

By comparison, other populations cannot easily or are historically not asked to participate. They include

• people living in rural communities, representing 20% of the United States population, according to the 2020 US Census.
• underserved populations in both urban and rural areas.
• people unable to take time off due to work or family obligations or without access to transportation solutions that allow for participation.

A hybrid DCT approach combines in-person and remote appointments and increases participation opportunities for historically underserved and underrepresented populations. The hybrid design reduces travel time and expands participation with simplified, remote access to specific trial components to engage a more diversified patient population. These decentralised technologies make it easier for patients to continue in the trials and offer investigators effective, digital solutions that eliminate unnecessary in-person medical visits and prolonged travel times.

Embrace the benefits of hybrid clinical trials

A fundamental premise in clinical trial design requires an alignment of needs for investigators and patients. For example, a clinical trial with hospitalised patients may require a traditional approach to serve the participants and researchers best.

Patient populations and investigators benefit from a hybrid clinical trial because they can work towards and often achieve these three outcomes.

1. Reach underserved & underrepresented populations: Hybrid clinical trials offer access to patients who may not otherwise be contacted or able to participate, thus increasing inclusivity in clinical research.
2. Enhance patient engagement: Streamlined digital experiences that align with more modern day-to-day experiences improve patient engagement with the trial processes and, thus, make participation more appealing.
3. Support overworked healthcare professionals: With healthcare workers overwhelmed, the hybrid approach in clinical trials helps them efficiently engage with patients, reducing the time burden often associated with traditional trials.

Conclusion

It’s important to understand that a DCT expands the opportunities for clinical trial design and taking a hybrid approach improves outcomes, without having to remake the entire process. One size or approach does not fit all in clinical trials.

The hybrid clinical trial model allows developers to create user-centric designs more quickly and effectively. Providers learn that DCT adoption only demands a partial move to digital technologies. The decentralised processes allow workflow improvements using some, but not all, digital solutions.

Most importantly, patients are part of a clinical trial that recognises their individual needs. Investigators strive to enrol a diverse patient population that best represents the disease or condition under study. And, as the complexity of clinical research continues to evolve, ongoing innovation will help meet industry challenges and react to the needs of patient participants – no matter where they live.