EPM speaks to Alex Guite, vice president of Services and Alliances at World Courier about the impact Covid-19 has had on the clinical trials sector and how a direct-to-patient approach can help trials continue.
Covid-19
EPM: What’s the impact been for clinical trials due to Covid-19?
Guite: Clinical trials have been disrupted worldwide with significant impact to the patients who rely on them, as a result of Covid-19. Manufacturers face patient safety risks, regulatory restrictions, funding issues, and logistical challenges associated with getting treatment to patients in this new context. In fact, a recent Association of Clinical Research Professionals study found that nearly 80% of clinical research study sites indicated at least one of their current trials had been put on hold or cancelled in recent weeks, which was something we are observing first-hand. These delays are a concern for trial participants, and the impact will be felt across entire rare or orphan disease populations. As a result, World Courier has been working to transition applicable clinical trials to a Direct-to-Patient model that allows the studies to continue while still protecting product integrity, minimising disruption to the treatment regime and, most importantly, assuring patient safety.
EPM: Following that, do you expect a fall in drug approvals due to potential delays within the clinical trials space?
Guite: While the long-term impact of drug approvals remains to be seen, a study of World Courier’s manufacturer customers found that 78% believe most delayed clinical trials will be re-initiated post Covid-19. The study also revealed manufacturers believe rapid approvals for new medical devices (e.g. ventilators) during Covid-19 could lead to faster approval pathways for drugs in the future, post-Covid-19. However, we have seen that collaboration and flexibility remain key for manufacturers as they continue to gather data and for patients as they continue to receive necessary treatments – and ultimately for products to be launched to the market.
EPM: What’s World Courier doing to help clinical trials continue to operate?
Guite: Traditionally, clinical trials are conducted at a clinical site – within a hospital or healthcare setting – but Covid-19 has made it difficult for patients, particularly those who are most immunocompromised or vulnerable, to leave their homes. As a result, many of our customers are seeking innovative strategies for bringing the clinical trial to patients, rather than asking patients to come to the trial. We have extended our established Direct-to-Patient logistics model to support trials shifting from the traditional setting to the patients’ home, as well as managing the set-up of new trials with a Direct-to-Patient model. In fact, during the month of May we have expanded availability to 56 countries as some countries lifted restrictions on these types of services to care for patients and continue trials during this time.
EPM: How can a Direct-to-Patient approach help continue clinical trials during the pandemic?
Quite: A Direct-to-Patient approach allows for drugs to be delivered and administered in the patient’s home and/or biological samples to be uplifted from the patient’s home. This enables patients to follow the current guidance of public health officials (i.e., social distancing and self-isolating), accommodates the re-direction of healthcare capacity towards Covid-19 treatment, as well as accounting for patients who may be reluctant to enter healthcare settings in the current environment.
We’ve seen a five-fold increase in our daily Direct-to-Patient shipments, compared to the pre-Covid-19 average. Delivering treatments directly to the patient’s home protects product integrity, minimises disruption, and – most importantly – assures that patients can continue to access medicine.
EPM: What are the logistical requirements needed to make this a possibility?
Guite: World Courier has a 50-year history of maintaining supply channels in times of public health crisis or transport disruption. And, while we’ve supported Direct-to-Patient clinical trials for many years and have established best practices for logistics management, the Covid-19 pandemic requires our logistics programs to be even more flexible, ensuring our customers can operate as close to business-as-usual as possible during this time.
When implementing World Courier’s Direct-to-Patient approach, before a product can even reach a patient’s home for administration, we must address the logistical barriers associated with shipping products – particularly in countries that have limited passage to prevent further spread of the virus. In some cases, these challenges have tripled the time it takes to manage a shipment. In turn, World Courier identified alternative routes that could expedite product movement but still ensure we’re meeting country-specific regulations. Even as commercial flight availability has reduced, we maintained air connectivity by booking space on airlines across a range of carriers. Having this diversity of options allows us to pivot based on the latest conditions and product needs. Because of our carrier-agnostic approach and contingency planning, we haven’t declined a single shipment since the start of the pandemic.
Another requirement to make Direct-to-Patient clinical trials a reality is protecting patients, our associates and all supply chain participants. To this end, we have supplied our drivers with personal protective equipment (PPE) and implemented a contact-free pick-up and delivery process. These process modifications are temporary and in line with World Health Organisation guidance on social distancing, use of personal protective equipment and infection control.
EPM: What lessons do you think the pharma industry and governments need to learn from Covid-19?
Guite: Coming out of the Covid-19 pandemic and looking ahead, the pharmaceutical industry will keep a number of key learnings in mind. One lesson learned is the need to be prepared, flexible and collaborative. Manufacturers should look to logistics partners to ensure they have a proven track record of successful contingency planning – inclusive of maintaining air connectivity and the time and temperature requirements of specialty drug product.
Covid-19 has illustrated the importance of anticipating demand surges moving forward. Pharmaceutical logistics has always required widespread cross-border and cross-agency collaboration, and pharmaceutical companies should continue to collaborate with authorities and government officials to ensure patients are able to get medications in a time of crisis.