Author: MRN
When it comes to Decentralized Clinical Trials (DCTs) there are a multitude of myths and misconceptions about what they are and how they work, with both patients and clinical sites not fully understanding the benefit they can potentially bring – making participation easier and enrollment and retention faster and more efficient.
The human touch in DCTs: For Patients
One of the most common misunderstandings about Decentralized Clinical Trials (DCTs) is that they are fully remote, all done through technology and with minimal involvement from the site study team. Of course there are some DCTs that are indeed exactly that, but DCTs are actually more commonly focused on therapeutic areas that can be difficult to treat, especially those with neurological disorders, rare diseases, and cancer.
Very often the patients being treated in these indications are unable to travel due to mobility issues, severity of illness, or the increased level of anxiety that comes from being in unfamiliar surroundings or a hospital setting. By bringing the trial to the patient, either in a home or community-based setting, trials are able to provide a more comfortable option.
Further, in-home and community-based Healthcare Providers (HCPs) are able to build and develop a relationship with patients, especially as the same HCP will see the same patient for each visit. HCPs are also able manage or, when appropriate, educate patients on how to use the technology to improve participation and compliance, should the need for technology use arise. MRN in-home and community site HCPs use MRN’s fully validated and regulatory approved eClinical Platform in order to remotely record their visits in an eVRF. This is then immediately accessible to the site and/or sponsor. This ensures that the site, sponsor, and patients are all getting what they need, without additional stressors.
The human touch in DCTs: For Study Sites
Despite the benefits to patients, many traditional clinical trials sites have concerns around DCTs, making the assumption that patients will not receive the same level of care as they would when visiting the site, that they will lose oversight of their patients’ wellbeing, and/or additional work will be required to set up and manage the in-home/in-community HCPs.
However, when it comes to patient care, as well as oversight of their wellbeing, the only difference is the location in which the patient is treated. MRN’s in-home/in-community HCPs are all trained (by MRN) to the same standard on the protocol as the study site team and receive additional training to ensure they deliver the best care for the patient. Further, study site Principal Investigators (PIs) remains responsible for all patients’ oversight, including DCT participants. Together, the PI and the patient will review the available study visit types, determining which in-home visit options are best for the patient. They will also discuss which visits will have to be done at the site, so the patients understand if they need to come to the study site and why. Some patients may opt to participate in all available in-home visit options, while others may opt to have none. The PI will also approve the in-home HCPs that MRN has proposed as viable candidates, just as they would for any member on their site study team .
While it is true DCTs depend on regular communication between sites and solution providers to build trust, when a site management team is available to sites it actually helps to decrease site workloads. Site management teams build and maintain the relationships between all stakeholders involved, collaborating with the trial sites, and working with the study teams to determine what kind of support is required to give the site the most success possible.
Site management teams will work in harmony with the study sites, continually listening to feedback and regularly checking-in to ensure that all elements of the trial are running smoothly. MRN’s Site Management team includes experts in trial research with site experience as well as in-home visit experience, enabling them to evaluate and support processes, such as data collection and training, and ensure that study sites are fully supported and their needs met.
Ultimately, successful DCTs are those that focus on the success of the sites. The human touch plays a key role and is necessary to maximize the value of the DCT, while creating flexible and accessible patient-centric clinical trials.