Deploying appropriately trained, talented, and dedicated healthcare providers (HCPs) is essential to ensuring the quality and integrity of data collected during in-home patient visits. By selecting only HCPs who are adequately trained from a clinical perspective, the data will be more complete and require less follow-up, thus reducing the amount of time required to monitor the data. The result is beneficial all round – for the patient, sponsors, and clinical trial organisers.
Dr Art Lazarus, mdgroup’s Medical Director, spoke at SCOPE 2022 (Summit for Clinical Ops Executives), earlier this month to discuss how the latest medical technologies meet patient care to create remarkable patient experiences, and the important factors to consider when selecting Healthcare Professionals for mobile health patient visits.
On attending SCOPE 2022 remotely, Dr Lazarus said:
“It was great to learn that the industry as a whole is focusing on the design of decentralised clinical trials (DCTs) that don’t feel remote to patients. Of course, there was a rapid adoption of DCTs during the COVID-19 pandemic, as sponsors and CROs moved to ensure infection control measures did not bring research programmes to a screeching halt”.
“But now we are returning to something akin to normal business, there’s a growing realisation of the benefits DCTs can offer, such as expanding participation and increasing diversity, as well as the potential pitfalls associated with reducing face-to-face site visits – namely, a disengagement with the protocol which can contribute to poor retention. This year’s SCOPE recognised this crucial point”.
During his presentation, Dr Lazarus explained how essential patient-centric trial design is to the success of decentralised clinical trials.
“It was exciting to see a range of solutions that merge technology and the “human touch” being presented at the event. These included, for example, hybrid mobile health approaches that send local nurses to patient’s homes to collect data, helping them feel connected while still reaping the rewards of the DCT model”.
When asked about the future of decentralised clinical trials, Dr Lazarus added:
“I think there is still some work to do around increasing diversity among clinical trial participants. Historically, some racial groups and ethnic minorities have been underrepresented in research and this has contributed to health inequalities. While the situation is thought to be improving with regard to Black and African American populations, there is still a significant hill to climb in building Latino and Asian cohorts.”
“We cannot tackle the issue without robust data, yet the usual reference point for monitoring
diversity in clinical trials is the US Census. As such, I believe we need tools that can provide a more detailed assessment of ethnic representation, based on disease prevalence and epidemiology.”
It’s clear that decentralisation is changing the face of clinical trial development. A new precedent is being set for a clinical trial model that puts the needs of patients first, with the right healthcare providers at the heart of remarkable care.