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Back COVID-19 Speeds Adoption of Direct-to-Patient and Virtual Clinical Trials | Clinical Trial & Cold Chain Logistics

An aging population and growing middle class in both developed and emerging markets have set the global healthcare system on a path of transformation.

An aging population and growing middle class in both developed and emerging markets have set the global healthcare system on a path of transformation. That's because these demographic shifts lead to increasingly sedentary lifestyles that often lead to chronic illnesses. The medical community is responding by moving toward a more patient-centric approach – shifting focus to prevention and maintenance in an effort to prevent disease and the need for treatment. Patient centricity means putting patients first, of course, but also developing treatment plans specific to each patient.

In the biotech world, we’ve seen this patient-centric transformation as well with the continued growth in the field of personalized medicine. In recent years, there’s also been an increase in Direct-to-Patient (DTP) clinical trials. A study conducted in 2016, Assessing the Current and Future State of Clinical Trials, reported that 24% of those surveyed said they were using some form of a DTP model. Just over 30% more said they planned to move in that direction over the following 12 to 18 months. By the end of 2019, interest continued to grow as traditional healthcare companies were looking for new ways to revolutionize clinical trials with DTP.

Then came COVID-19, and everything changed. Clinical trials around the world were disrupted as borders shut down and immunocompromised patients could not travel safely to test sites. As a result, many CROs and sponsors found it necessary to move to a DTP model virtually overnight to keep trials moving and save lives.

Benefits of DTP Clinical Trials

DTP clinical trials offer several benefits to sponsors and patients alike. By adding DTP to a clinical trial, for instance, patients can reduce the number of site visits needed. That’s because instead of traveling to clinical trial sites, investigational drugs are delivered directly to the patient’s home. Depending on the type of study, a home healthcare nurse administers drugs and collects any patient samples needed – or the patient does it him or herself. Samples are then sent back to the central lab for testing and compiling data. This clinical trial model is especially helpful for patients living in remote areas or who are too sick to travel.

As clinical trials and drug development become more competitive, patient recruitment and retention is essential. A DTP model is useful in that it may give sponsors access to a larger patient population – people again who live in remote areas or in parts of the world that might not have been considered for the study before. By making it easier for patients to participate, it also increases the likelihood that they’ll stay enrolled, as one QuickSTAT client conducting a global Phase III study for a rare diseasefound. In this case, a biotech company was having trouble, not only enrolling patients, but ultimately keeping them in the study for a variety of reasons. QuickSTAT helped them establish a DTP model to minimize dropout and expedite enrollment.

Coronavirus Pandemic and Beyond

The pandemic brought with it unique challenges for clinical trials, particularly those already in progress where timing is so critical. On the front end, biologics need to be delivered within very tight timeframes and precise temperature ranges. Equally important is getting timely clinical data back to CROs, which they need to confirm that drugs are performing safely and effectively before bringing them to market.

Of course, the impact of COVID-19 on clinical trials went far beyond supply chain challenges. For QuickSTAT customers, it’s very much about the patients – and the pandemic brought a good deal of concern for many critically ill patients, some of whom might see their clinical trial as a last hope. That’s why so many chose to move to a DTP model as quickly as possible, including a range of CROs and large pharmaceuticals who either had trials taking place across five continents or needed to ensure an uninterrupted drug supply for immunocompromised patients. QuickSTAT even had one case where we were trying to outrun Hurricane Isaias and deal with the pandemic.

The last year's experience has sponsors and CROs re-examining their protocols with an eye on speeding clinical trial completion and lowering overall costs to enhance revenue potential. There’s an uptick of interest in a virtual model, for instance, that goes beyond just DTP to eliminate physical trial sites altogether and rely more heavily on technology. This includes incorporating telehealth visits, which patients have rapidly adopted throughout COVID-19, and other digital solutions for collecting data directly into the study's design from the start.

The key to success is choosing a logistics partner who can help build a robust and patient-centric supply chain from the outset. Having a knowledgeable logistics partner and a reliable, flexible supply chain in place will help mitigate a lot of risk, even when a global crisis such as COVID-19 comes along.

QuickSTAT has been working with CROs and sponsors on DTP clinical trials for several years and has proven expertise in everything from the latest temperature monitoring technology to HIPPA compliance. If you need help setting up a new or transitioning an existing clinical trial to a DTP or virtual model, please get in touch with us today.