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Decentralized Clinical Trials: How to Balance Technology & Humanity

Cassidi Williams

Keeping the Human Touch

Hybrid and decentralized clinical trials (DCTs) are becoming more prevalent as they can better address the constraints associated with in-person visits including: mobility, proximity to research sites and the time or cost associated with attending the clinic. Although DCTs can be more convenient than in-person trials, is there a risk of relying too much on technology at the expense of person-centered communication? Clinicians understand the effort required to maintain the right balance between leveraging technology and preserving the physician-patient relationship throughout the clinical trial participation experience. While it's critical to embed technologies to support efficient trial conduct, study design and planning needs to intentionally deploy the right solutions to support remote trial management, without overlooking the needs of the participants in their treatment journey.

The Importance of Patient-Centric DCT Design

Depending on the clinical indication and phase of care, study participants will know more or less about the health system, clinical trials and options available to them. Participation in a clinical trial is asking patients to commit to receiving a novel therapy and following a schedule of activities during, what can be, a time of anxiety and vulnerability in someone’s life.

DCTs should be designed and conducted in a way that is sensitive to the human needs and emotions of trial participants in uncertain times. Adopting a patient-centered study design means understanding that every patient comes in with differing lived experiences, needs and expectations. There are certain considerations that sponsors and DCT study teams should plan for upfront including:

  • The digital divide; readiness and availability of devices and connectivity in any given participant population
  • Acceptability of the planned DCT design by participants and their caregivers
  • Accessibility and simplicity of user interface (UI) and user experience (UX) design
  • Consistent use of “people-first” language throughout participant facing materials including DCT technologies

During recruitment and screening interactions, participant messaging should be as transparent as possible about the study interventions and schedule to empower participants with knowledge and reduce uncertainty. Access to training and support for patients, especially as it relates to contact with the site staff and care team, are important to prevent participant isolation and disenfranchisement with the clinical trial process.

DCT Patients & Caregivers

There are known positive associations between patient experience and adherence to treatment, health promoting behaviors and resource use. DCT designs, incorporating Patient Reported Outcome (PRO) data, establishes the participant as a direct key contributor of study data. This is a shift in power from traditional studies without PRO data and puts control square in the hands of participants and caregivers.

DCT technology can be leveraged to facilitate thoughtful and timely patient engagement strategies. Notifications, visit reminders, motivational messages and dissemination of study progress updates are tangible ways to include participants as partners to improve retention.

Reducing or removing the need for in-clinic visits doesn’t eliminate a need for clinicians to establish relationships with patients and caregivers to better understand their needs and concerns. In DCTs, there’s greater opportunity for home healthcare professionals to be integral to the clinical care and disease monitoring of trial participants. DCTs can be used to facilitate convenient access to care, maximizing participation, retention and protocol adherence.

There are a myriad of technologies that make DCTs possible. Telehealth, integrated medical devices, sensors and consumer wearables all utilize remote data capture as well as allowing for data donation. Home healthcare professionals and family members who act as caregivers must understand how to use in-home clinical trial technology.

Connecting with Clinical Trial Patients

While it might not be possible for today’s clinical research studies to effectively and efficiently address each patient on an individual basis, there is ample opportunity to better incorporate the patient voice throughout a trial. Sponsors and CRO’s can take the first step to identify needs and find a common thread for the study patient demographic. Messaging, recruitment, study design and protocol information can all be adjusted with the patient voice in mind. The right DCT trial management systems deploy a simple step-by-step process that allows sponsors and CROs to easily configure DCT technologies and participant-facing websites. These automated, web-based solutions empower patients with study knowledge every step of the way, for a positive participant experience and improved study performance.

Contact THREAD to learn how to design a DCT that balances technology and humanity.

Sinead Callinan

Executive Director of DeliveryEMEA

Sinead is a Digital Healthcare and Clinical Research Executive with a career spanning clinical care, academic research and digital health across multiple therapeutic areas including oncology, internal medicine and vaccines development. She joins THREAD with over 18 years of experience in clinical service delivery, sponsor research governance, CRO and eHealth.