Author: Leandro Moreira, SVP of Corporate Development, Yourway
DEK: While the emergence of the COVID-19 pandemic has led to widespread embrace across the industry of decentralised clinical trials models including direct-to-patient (DTP) and direct-from-patient (DFP) supply and healthcare services, the pandemic has also introduced novel challenges and complications onto DTP/DFP logistics. Additionally, more sponsor companies who had previously only flirted with the idea of adopting these models begun to do so urgently to without having the time to investigate and develop their own best practices, including how to select an appropriate logistics partner.
Implementation of direct-to-patient (DTP) trials has involved a new 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 and control and a risk management approach to predict potential quality issues before they arise, which avoids those obstacles. DTP protocols and decentralisation of clinical trials have been significant factors in this success.
Patient confidentiality has always been a concern in clinical trials, and DTP and platform technology have improved to address this challenge. Every digital platform and storage system must ensure good practice quality with regulatory guidelines across multiple venues. Couriers must adhere to strict confidentiality practices as well, and appropriately managed DTP services minimise these risks of information getting exposed improperly. Logistic challenges have included compliance with the Health Insurance Portability and Accountability Act and General Data Protection Regulation (GDPR), which not only applies to EU organisations, but those outside the EU as well.
Almost 85% of clinical trials fail to maintain viability because of inability to retain enough patients. Patient enrolment must be a strategic effort, and the challenges have increased due to 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 a clinical trial at all. In fact, less than 10% of patients with chronic illness will typically participate in clinical trials because of randomisation. Patients are averse to enrol in an experimental trial for a drug when they know that there is a real possibility that they may not even receive the drug and therefore loose any possibility of the drug's benefit when they need it the 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 been a key factor in improving patient satisfaction and compliance, because of enhanced patient centricity and the advantages of real-time monitoring. Decentralisation enables trials for patients in remote locations or nonambulatory patients. Recruitment of patients can be done by e-recruitment methods, such as social media, which can further increase the likelihood of patient participation, particularly if patients know the trial will come to them instead of the other way around. Recruiters are also venturing into text messaging, email, smartphone applications, and the like.
Patients who are immunocompromised have unique challenges, since 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. In some cases, the solution involves digital applications that can be downloaded onto a smartphone or tablet. These applications must be compliant with 21 CFR Part 11 requirements. This technology boosts patient access from local to global outreach and does so securely. Patients enjoy the convenience, and investigators revel in the increased patient satisfaction and retention, as well as the speed and quality of data collection.
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 high technology solutions available today, patients have more options than ever before. COVID-19 has just made some of these logistics 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 the 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, 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 IMPs having a short 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 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 can entail considerable coordination and planning. It is crucial to develop strategic partnerships with clinical trials logistics providers with 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 centre on the in-home healthcare component, customised to the client’s needs. Using the DTP model, the nurse’s role includes delivery and administration of the IMP, which may come from the study site or from a depot facility. The protocol may also include the nurse’s collection of any pertinent laboratory samples. The orchestration of the delivery of the samples, which may be delivered to different laboratories under different instructions, must be planned. 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 if they can minimise the vulnerabilities and challenges of securing all of these services from different providers, and combining everything into Yourway's integrated platform maximises efficiencies and speed.
Global logistics continue to improve. Yourway is adding new technologies and capabilities for tracking and tracing. Patient privacy is a crucial component to ensure that information is shared properly and according to strict encryption, patient consent, and government regulations and guidelines. Information is stored only if storage is permitted and under specific guidelines and country-specific regulations. Data security, integrity, and privacy must be interwoven to achieve the best possible results.
One area of innovation that is certain to play a significant role in the future of decentralised clinical trials is wearable technology, which is one of the fastest growing sectors in the broader technology industry. Internet of Things (IoT)-enabled wearables not only enable remote monitoring of outcome measurements that formerly required visits to clinical sites, they offer the potential to provide real-time data, something completely unprecedented in conventional clinical trials. Even before the pandemic drove more concentrated interest in decentralised, DTP trials, over 500 clinical trials implementing wearables were underway, and Kaiser Associates and Intel have projected that 70% of clinical trials will incorporate wearables by 2025. In anticipation of the broad adoption of wearables in clinical trials, researchers are currently validating the feasibility of wearables in studies, and sponsors are partnering with device makers to evolve endpoint data collection and validation. Successful integration of wearables into clinical studies will hinge on collaboration with regulators to ensure that the scopes of clinical studies incorporating wearables are well defined and that outcomes can be achieved and implemented, as well as to ensure compliance with regard to data privacy, integrity, and security. Yourway is already prepared to support this new frontier of clinical trial technology.
Yourway has been a global expert facilitator in the paradigm shift from traditional, centre-based trials to decentralised DTP studies. There are several benefits to decentralisation that have come into sharper focus because of the pandemic. Sponsors no longer must be limited to a specific geographic location. The treatment can go to the patient instead of the patient going to the clinical study. This helps with recruiting in that it reduces the need to recruit patients from specific geographic locations. Another benefit is patient retention, since patients are less likely to drop out of a study because of the convenience granted by the DTP approach. Patients are relieved not to have to go to a clinic or treatment site to receive treatment, making the process more comfortable, which improves patient compliance and retention. In Yourway’s hands, trials can be more adaptive, customisable, and flexible.
Yourway has been providing DTP services since trials began to be decentralised several years ago. The company has leveraged creativity and the expertise to provide solutions that are meaningful, relevant, and timely. One of Yourway’s first projects was a pediatric study of an orphan drug for a rare disease. Company processes and scheduling are precise and efficient; the team always meets delivery deadlines.
Yourway understands that some studies cannot be completely decentralised. In these cases, the DTP approach is included on the protocol as a contingency; in other cases, trials involve a hybrid strategy with centralised and decentralised elements. In many cases, some patients are offered an option: if the patient is unable to go to a study site, then alternative arrangements will be made.
The combination of in-home healthcare using the DTP model with specialised logistics is paramount and a strong differentiator for Yourway. Everything is done for patient convenience, including infusion, having EKG machines, and even having centrifuge machines sent to the patient’s home so the collections of blood samples can be done right there. Everything Yourway does helps to create a virtual hospital experience, right in the patient's home.
Yourway’s single-platform infrastructure reduces the number of providers involved, which minimises vulnerabilities. Project managers coordinate 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 and privacy, and data integrity are central to all company procedures and methods. One project manager is assigned to a client. The project manager is well-versed on all the aspects of the project and is the navigator in terms of clinical packaging needs, any kind of supplies, and any kind of transportation needs. 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 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.