H Clinical News

More patients worldwide participate in clinical trials from home. According to an article from Applied Clinical Trials, decentralized clinical trials are the reason why. As the COVID-19 pandemic began to impact study conduct in 2020, the need to adopt decentralized trial models was hastened to keep research moving forward.

Logistics and Infrastructure

But unlike most topics on decentralization where the focus is primarily on technology to help manage studies remotely, this article focuses on necessary infrastructure. Success depends “on the logistics solutions in place to support manufacturers’” ability to manage regulatory requirements, administration of home health care and medication adherence, and the delivery of time- and temperature-sensitive products.

The direct-to-patient model significantly improves patient recruitment and retention. But this requires bringing therapies and customized care directly into the home. This feat can only occur with a high level of coordination across the supply chain. Therefore, sponsors need to collaborate with “logistics partners who can support delivery across the world within a predetermined, extremely narrow timeframe. This is often timed with the arrival of a home healthcare provider.”

H Clinical supports logistics and infrastructure in 22 countries throughout Latin America and Central America.

Home Healthcare and Medication Adherence

Having the resources necessary to implement a therapy regimen is critical. Whether administering phlebotomy or injecting medications, home health support is integral to the success of direct-to-patient at-home trials. Having a network of certified clinicians and GCP-trained mobile nurses to support this approach optimizes the delivery of patient care. This is especially true for trial participants who are challenged by distance, lack of transportation, or the physical and financial strains of fighting a disease.

The H Clinical View

Applied Clinical Trials concludes the article by acknowledging the direct-to-patient decentralized clinical trial model is here to stay. Why? Because in a survey by AmerisourceBergen 76% of manufacturer partners indicate that they plan to offer this trial design moving forward. Success will depend on precise coordination between stakeholders across the supply chain. This includes logistics and technology partners, home healthcare providers, sponsors, and patients. H Clinical provides the infrastructure, logistics, and home healthcare resources to bring direct-to-patient clinical trials home in Latin America.