The COVID-19 pandemic has wrought havoc on clinical trials, with thousands being suspended or stopped due to difficulties in continuing under lockdown condition. Research suggests that 80% of clinical research participants indicated that they were unwilling to visit the trial site for study appointments.
The clinical trials sector has had to pivot quickly. Informaconnect research shows that 84% of respondents say it is ‘likely’ or ‘certain’ that their company will increase the use of decentralized/virtual or hybrid trials in the next two years. While the benefits of shifting to virtual trials have been discussed for years, COVID-19 highlighted that there are still challenges to be address for technology-driven virtual trials to succeed.
Patient centricity and the growth of Direct-to-Patient
With so few patients willing to participate in on-site trials, trials at home, where patients don’t have to travel, are likely to be more attractive.
A Direct-to-Patient (DtP) model has been shown to boost patient retention – and increase adherence – for clinical trials. A survey of clinical trial suppliers found that the main reason for adopting DtP was to improve patient retention, and direct shipping has been gaining ground for some time. With COVID-19, the ability to directly ship investigational medical products – and retrieve samples – is essential to enable clinical trials to continue.
Supply chain planning and new distribution models
Inventory management has always been difficult within clinical trials. Formulations aren’t fixed and can change regularly. Inventory levels can be dictated by patient enrolment numbers, which are often uncertain, making centralized planning difficult. When products are distributed on an individual basis, the task is multiplied. In the past, clinical supply teams have had an over-reliance on overage to accommodate changes in demand, but this approach is expensive and inefficient.
To drive up efficiencies, collaboration during the protocol design phase is important. The clinical team and the clinical supply team should consider important operational decisions such as visit intervals, kit design, dose levels and drug formulation, all allied to a digital supply chain platform.
The challenge of the ‘last mile’
One of the key success factors of any trial, virtual or not, is to ensure patients are randomly allocated to treatment groups, treatments are delivered on time and in the correct dosage, and patients comply to study treatment as defined in study protocol – all while keeping the study blind.
A generation of interactive response technology (IRT) has developed to help manage this task. However, for virtual trials, many IRT systems have been poor at managing the last mile to the patient’s door. The rapid deployment of Internet of Things (IoT) sensors and devices in the clinical trials supply chain is beginning to fill this gap.
IoT-enabled sensor technology captures and records drug, environmental, and patient adherence data in real time, allowing rapid insights and evaluation. The temperature monitoring and excursion management capabilities of IoT platforms – such as the OpenText™ IoT Platform – help organizations meet their regulatory mandates for product in transit.
A digital platform for the remote trial ecosystem
Digitally capturing the last mile is only part of the challenge in a supply chain that still lacks an end-to-end digital infrastructure. A central enterprise platform is required to manage inventory and orders, effectively forecast patient requirements, ensure efficient supply of treatments to the patient wherever they are, and manage the collection of samples from the patient and distribution to test labs.
This needs coordination and visibility across a wide range of systems in manufacturing, storage, and logistics. More than this, the platform must provide collaboration and information sharing capabilities for the many different parties involved in the virtual clinical trial process. As more CROs and CMOs are used, the partner ecosystem grows, and the platform must be able to support the B2B relationships and transaction necessary to ensure effective and cost-efficient manufacturing and supply chain processes.
This platform provides the data management and data protection that trial organizers need to ensure they remain in compliance with the locations where the trials are being conducted – including how patient information is made available and shared between parties in the supply chain.
Gaining insight from patients in the real world
To make clinical trials more accessible and effective in a virtual setting, the deployment of a single platform for the unified integration of systems and data facilitates the process of collecting, preparing and analyzing trial participant data. This includes real world data from medical apps and wearables managed by the patient.
The benefits of this level of insight and analysis for virtual trials are huge: more consistent monitoring at-home may enhance a clinical trial’s statistical effect size, reduce the number of patients needed for any given trial with quicker access to richer data to demonstrate a drug’s efficacy and safety.
Changes to the Life Sciences supply chain in the post-COVID world is one of the topics we’ll be covering at this year’s OpenText™ World conference (26-29 October). Register your place today.