Understanding the place of Direct-to-Patient in a post-COVID landscape
The COVID-19 pandemic has propelled a transformational shift in the clinical research industry, catalyzing a fundamental change in the way trials are executed. It has meant finding alternative ways of working with a popular method emerging in the form of the decentralized trial (DCT).
The industry was already moving towards decentralization of clinical trials, but the outbreak accelerated the trend as a response to social distancing regulations implemented across the globe. According to a World Courier study, some 46% of respondents switched their trials from site to patients’ homes, allowing continuity of care for patients, as well as business continuity1.
A comprehensive Direct-to-Patient (DtP) logistics service was vital to the success of DCTs during the COVID-19 pandemic. DtP enabled the transportation of clinical trial material (CTM) and return samples to and from the patient quickly, safely and often within strict temperature constraints.
Now that the global economy is beginning to open up again, though, will DCTs and DtP continue to enjoy strong demand from the pharmaceutical industry?
The advantages of DCTs beyond COVID-19
The traditional trial model offers a number of disadvantages. Some 70% of potential clinical trial participants live more than two hours from a study center2. Many patients are unwilling or unable to make such long journeys to participate in a trial, limiting their access to new studies. They may be too unwell, have mobility or childcare challenges that make traveling difficult.
As a consequence, many clinical sites struggle with patient recruitment. Some 85% of all clinical trials fail to recruit enough patients, 37% of investigator sites under-enroll, and 15% fail to recruit a single subject2. Retention is also an issue, with 30% of patients dropping out2. These problems are particularly acute for trials for treatments of orphan diseases - the rarity of these conditions means there is already a very small pool of potential patients, which risks being shrunk further by poor patient convenience. As a result of these recruitment issues, up to 80% of clinical trials are delayed2.
DCTs provide a more patient-centric alternative to traditional on-site trials, with benefits that extend far beyond the ability to overcome COVID-19 social distancing obstacles. They make it possible for the majority of patients that may be unable to travel long distances or even overseas to a clinical site to participate. This can enhance patient recruitment, improve the diversity of the patient pool, and boost patient retention. In fact, pharmaceutical companies report being able to recruit 50% more patients to a DCT than a traditional trial.
With all of this in mind, it is no surprise that some 7% of clinical trials taking place currently have some sort of DCT component being reported within them, up from 3.5% pre-pandemic3. We can expect demand for DCTs to remain strong even after COVID-19. They provide a means of supporting the innovation of treatments for orphan diseases - there are currently 791 orphan medicines currently in development4. In addition, through enhanced retention and diversity, they can boost the effectiveness of larger trials.
DCTs necessarily have complex logistical requirements, and this will continue to be the case beyond COVID-19 and into the future. The CTM must be transported from the manufacturing site to the patient’s home or local pharmacy or clinic quickly and safely. The drug product may be heavy, fragile and temperature sensitive, requiring storage within strict temperature limits. Returns of unused drugs and specimen samples from the patient must also be collected and shipped to a lab for analysis, again often with similar environmental controls.
There are also a lot of materials for in-home use needed in a DCT. These include medical devices, lab kits, and sample kits for patients to use to collect the samples they need to return.
For global trials, all this material may have to cross multiple international borders. This means that the CTM, support materials and samples must all be packaged, stored and transported in a manner that complies with the regulations in each of the countries they pass through. They also must have the relevant paperwork completed accurately to minimize delays.
A comprehensive DtP service supports DCTs in addressing all of this complexity, providing a robust and reliable approach to delivering CTM and returns where they need to go safely, securely and rapidly. We can expect demand for DtP to continue to grow as demand for DCTs does, to meet the needs of increasingly global studies.
Harnessing expert guidance
Even as we leave the COVID-19 era behind, pharmaceutical companies will need DtP logistical support to meet their growing DCT needs. Collaborating with expert logistics partners can help them build robust DtP supply chains to ensure their trials take place smoothly and efficiently.
World Courier has a heritage of providing clients with comprehensive DtP support for their DCTs. In 2021, we supported clients in the delivery of some 40,000 DtP shipments to ensure the seamless operation of DCTs for a wide range of vital clinical studies. With the support of a partner like us, pharmaceutical companies can be confident they have the logistics guidance they need to carry out successful DCTs well into the future.
To learn more about the future of DCTs and DtP post-COVID 19, watch our recent webinar on-demand with our partner, The Medical Research Network, an innovative, market-leading clinical trial support organization that has been driving DCT growth for more than 15 years.
1 Carried out in 2020, with 132 responses and 9 interviews
3 U.S. National Library of Medicine
4 New Report: Nearly 800 new medicines in development to treat rare diseases