COVID-19: The Impact on Clinical Trials Provides A Catalyst for the Adoption of Decentralized Trials

Author: Scott Ohanesian, Senior VP of Commercial Operations, QuickSTAT

Update : 29th October, 2020

COVID-19 has brought many supply chains around the world to a standstill almost overnight – however, this is not an option when delivering life-saving medication or treatments, whether in the clinical or commercial stage.

When discussing the collateral impact of COVID-19, the Director of the WHO Division on Noncommunicable Diseases, Dr. Bente Mikkelsen, confirmed the results of recent studies show “there is a disruption in healthcare services, including NCD diagnosis and treatments, in 69 per cent of cases.”

Despite the continued prevalence of COVID-19, sick patients still need to receive their life -altering treatments, and new therapies still need to be supported through clinical development to bring hope to those facing debilitating, and in some cases fatal, diseases. In the world of clinical trials, time stops for no one and since the onset of the pandemic our industry has embraced a decade old, but still underutilized, decentralized clinical trial model to ensure that patients receive their treatment without delay.

What is a Decentralized Trial and Why Should You Leverage This Model for Your Next Trial?

A decentralized clinical trial (DCT), which the FDA defines as a trial executed through telemedicine and mobile/local healthcare providers, using processes and technologies that differ from traditional clinical trial models. A properly implemented DCT is patient-centric by design, as the burden for site visits to specific locations is significantly reduced, thereby allowing more patients to participate. Investigational drugs are delivered from central or local site pharmacies directly, where the therapies are administered and patient samples can be collected by the patient or with the help of a home health nurse, where they can be sent back to a central lab for testing.

By leveraging a DCT model, drug developers have been able to achieve faster patient recruitment, greater patient retention, and increased patient compliance that can speed trial completion. The model also helps to lower overall development costs. The DCT model has been especially effective for pediatric and geriatric stakeholders, as well as for patients unwilling or unable to travel to clinical sites for treatment -- whether due to living in a remote area not close to sites or the patient is suffering from a debilitating disease that make mobility or travel difficult. Limiting the number of site visits makes it easier for families and caretakers who still might need to work or have additional responsibilities.

COVID-19 and the Adoption of DCT Model

In March 2020, as the COVID-19 pandemic overwhelmed hospitals with patients seeking treatment and forced public transportation in many countries to shut down, hundreds of thousands of patients participating in clinical trials were left in a precarious situation of not having the ability to access their clinical site to receive their treatment. As we know, necessity is the mother of invention, and many regulatory bodies and ministries of health around the world provided exemptions and created a pathway for thousands of trials to leverage a DCT model, more specifically a direct to patient supply chain, that allowed clinical trial patients to receive their treatments from the safety of their own home.

As a global direct-to-patient (DTP) logistics provider, QuickSTAT was proud to be in a position to support many sponsors, CROs, and home health nurse networks with the conversion of hundreds of trials across four continents to a decentralized trial model. This helped to ensure the expeditious delivery of thousands of treatments and the collection of thousands of patient sample shipments from clinical patient’s homes across dozens of countries.

The lingering effect of COVID-19 still makes it concerning for immunocompromised patients requiring treatment to travel to hospital sites where clinical trials are supported, especially with the possible resurgence of COVID-19. Therefore, drug development sponsors are looking to expand and extend the use of DCT models to ensure patients will continue to receive their treatment. QuickSTAT has seen a 40% year over year increase in requests for the use of DCT supply chain models for both new and already opened clinical trials.

The Future of Decentralized Clinical Trials

Prior to COVID-19, the concept of a decentralized clinical trial was already gathering advocates who can see the benefits to patients and drug developers the model offers. However, the utilization of DCT, and more specifically direct to patient supply chain models, has still not been as widely adopted as one would expect from a patient-centric model that can deliver a faster patient enrollment and increased patient retention needed to accelerate trial completion and reduce overall trial costs.

By forcing drug developers to convert hundreds of trials to a DCT model that leveraged direct to patient supply chains, COVID-19 has absolutely been a catalyst for giving sponsor companies the critical experience of operating within a decentralized trial framework. I believe that the confidence gained from successfully implementing DCT models to support global clinical trials, combined with the real need to compete with other sponsor companies for patients, especially for therapies with blockbuster potential, by providing them with a patient-centric trial design that minimizes the impact of the trial on their normal day-to-day life.

Our industry appears to share this sentiment, as clinical trial service vendors, such as Fisher Clinical Services, Catalent, and PCI all offer direct to patient services. Additionally CROs, such as ICON and Covance have invested millions of dollars in the acquisition of home health networks who allow for mobile nursing visits.

The CEO of Covance, Paul Kirchgraber M.D., has gone so far as to focus the company’s future growth around the transformation to becoming a decentralized CRO, as he anticipates, “that by the end of 2021, the majority of (their) new studies will include a decentralized component.”

In all aspects of their lives, people are becoming used to receiving at home deliveries, leveraging technology and digital mediums to engage the world around them; inevitably these same people, as patients, will expect a clinical trial designed in the same manner. Whereas decentralized trials were always perceived as cutting edge despite decades of use, COVID-19 has shown that decentralized trials are not a luxury, but a necessity for the future development of critical therapies.

About the author:

Scott Ohanesian, Senior VP of Commercial Operations, QuickSTAT

Scott Ohanesian has held executive roles over the past 17 years for Clinical Logistics Organizations and Contract Manufacturing Organizations (CMOs), managing global logistics for Phase I through IV clinical trials. He currently leads the QuickSTAT U.S. commercial operations team to build strategic relationships with pharmaceutical and biotech companies in order to provide comprehensive solutions for their global supply chain, ensuring product integrity and patient safety.

Website: QuickSTAT

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