Although the emergence of COVID-19 has led to an industry wide uptake of decentralised clinical trial models — including DTP and direct-from-patient (DFP) supply and healthcare services — the pandemic has also introduced novel challenges and complications in terms of DTP/DFP logistics,1 reports Leandro Moreira, SVP of Corporate Development, Yourway
Additionally, a number of sponsor companies who had previously only flirted with the idea of adopting these models began to do so, quite urgently, without having the time to investigate and develop their own best practices, including how to select an appropriate logistics partner.
Implementing DTP trials involves an extra challenge: quality-by-inspection instead of quality-by-design. Quality-by-inspection can hinder innovation because it requires constant change when something new arises.
By contrast, quality-by-design emphasises product and process understanding, as well as a control and a risk management approach, to predict potential quality issues before they arise, which avoids those obstacles.
Patient confidentiality has always been a concern in clinical trials; thankfully, DTP and platform technologies have improved to address this challenge. Every digital platform and storage system must ensure compliance with regulatory guidelines at multiple venues.
Couriers must adhere to strict confidentiality practices as well; appropriately managed DTP services minimise the risk of this information getting exposed improperly.
Logistics challenges also include compliance with the Health Insurance Portability and Accountability Act and General Data Protection Regulation (GDPR), which not only applies to European Union (EU) organisations, but to those outside the EU as well.
Almost 85% of clinical trials fail to maintain viability because of their inability to retain enough patients. Patient enrolment must be a strategic effort, which has become increasingly difficult because of the pandemic.
There has been an acceleration in the need for trials to be more patient-centric, focusing on the patient perspective and what would hinder a patient from considering taking part in a clinical trial at all.
In fact, less than 10% of patients with a chronic illness will typically participate in clinical trials because of randomisation. Patients are disinclined to enrol in an experimental trial for a new treatment when they know that there is a real possibility that they may not even receive the actual drug … and therefore miss out on any chance to benefit from its effects when they need it most.
Patient concerns also extend to their reservations about experimentation, lack of potential health benefit, physician influence and inconvenience, which has worsened because of the pandemic.
Decentralisation has also played a key role in improving patient satisfaction and compliance, because of enhanced patient-centricity and the advantages of real-time monitoring. Decentralisation enables trials to be run for patients in remote locations or non-ambulatory participants.
The recruitment of patients can be done using digital technology tools, such as social media, which can further increase the likelihood of patient participation. Recruiters are also venturing into text messaging, email, smartphone applications and the like.
Patients who are immunocompromised have unique challenges; any travel at all may place them at unnecessary risk. The global pandemic has only worsened these risks, particularly for the most vulnerable. Virtual patient management, including DTP care, decentralisation and telemedicine, has expanded the capabilities of ongoing trials, as well as new ones being initiated during the pandemic.
The selective targeting of patients in specific locations has become more commonplace. This strategy is improved by effectively removing the barriers for treatment, such as the patient physically being able to get to the treatment site.
Patients with rare or advanced clinical diseases face a high medical burden; but, with the capabilities of DTP studies and the availability of the high technology solutions available today, patients have more options than ever before. COVID-19 has just made some of these logistical issues more challenging.
DTP clinical models were met with resistance before the pandemic struck. Assurances had to be made to both patients and sponsors that home visits would decrease and not increase patient risk because of the possible exposure to COVID-19.
Many patients wanted no visitation at all, even to their own home, let alone a clinical study site or hospital. This expansion to the DTP model broadened the horizon of available studies for even the rarest diseases, orphan indications, dispersed patient populations across the globe and children.
Clinical trial sponsors have demanded proper compliance during the pandemic, along with the necessary levels of patient-centricity and reliability. DTP services and decentralisation have broadened the scope for many clinical trials.
Travel during the pandemic has been restricted, with airline schedules either limited or completely closed because of specific country regulations. Nonetheless, equipment still had to be positioned properly to enable clinical trials.
Crucial deadlines further complicate matters, with many investigational medicinal products (IMPs) having limited viability (some as short as 8 hours).
The pandemic has forced the clinical trials industry to venture into new territory. For any trial, specific guidelines prescribed in study protocols and pharmacy or lab manuals must be understood in detail to enable the development of appropriate solutions based on factors including the number of patients and the countries in which the study is conducted.
Well-executed DTP and DFP studies require the seamless delivery of the IMP and collection of samples. Careful attention must be paid to maximise operational logistics, costs and efficiencies.
Many study protocols require Yourway’s driver to wait for the nurse to conduct the visit, finish administering the IMP that was delivered and orchestrate the delivery of the sample or samples to the laboratory or laboratories, all at the same time.
There could be multiple samples and multiple laboratories with different requirements, so the process could entail considerable co-ordination and planning. It is crucial to develop strategic partnerships with clinical trial logistics providers who have the experience and capabilities to address these diverse needs. At Yourway, we offer the full complement of integrated services to do just that.
Yourway’s focused solutions center on the in-home healthcare component, customised according to the client’s needs. Using the DTP model, the nurse’s role includes delivery and administration of the IMP, and the collection of any pertinent laboratory samples.
Finally, any unused IMP must be returned to the site or to a depot for accountability and destruction, which is another one of the nurse’s responsibilities that Yourway oversees.
Our logistics services and technologies include everything from packaging, basic transport services and temperature control to blinding and randomisation.
As a truly integrated clinical services provider, we can handle all these needs for a clinical trial sponsor, beginning with primary and secondary clinical packaging, as well as ancillary or comparator drug supply, whole randomisation, kitting services, label design and anything else to support the clinical study.
Every time a product changes hands, there is room for error, and DTP models increase the number of such exchanges. Sponsors can uncover significant benefits in terms of minimising vulnerabilities and securing all of these services from different providers and combining everything into Yourway’s integrated platform.
Yourway’s single-platform infrastructure reduces the number of providers involved, which minimises vulnerabilities. Project managers co-ordinate and work on real-time solutions according to the study protocol and the specifics of certain regions on a global level according to local guidelines.
The process is seamless, with regulations, patient safety, privacy and data integrity all being central to company procedures and methods. One project manager is assigned to a client.
The project manager is well-versed in all aspects of the project and is the navigator in terms of clinical packaging needs, any kind of supplies and any type of transportation. In other words, the project manager is the single point of contact who knows their project in full and can provide convenience and surety.
During an unprecedented crisis, Yourway has not only confronted the challenges and obstacles caused by the pandemic, but has also been able to enhance its systems and services to create more efficient and patient-centric solutions via the DTP model and decentralisation.
The company’s role is to provide superb, customised solutions that exceed customer expectations to improve patient experience and overall care — and make clinical trials as efficient and successful as possible.