In the ever changing landscape of the healthcare sector, we are seeing some big changes taking place, such as the integration of AI, a focus on diversity in clinical trials and the rise of digital healthcare and at-home diagnostics to name a few. Most advancements can be linked to the growth of decentralised clinical trials.
Decentralised clinical trials (DCTs) offer research studies a more accessible, efficient, and patient-centric method of gathering data. Helping to reshape how clinical research is conducted and managed.
It is expected that the use of DCTs is going to increase significantly, with the global market size expected to grow from $8.19bn in 2024, to $24.97bn in 2032. The Asia-Pacific currently holds the majority market share too.
In response to the global pandemic, DCTs helped mitigate delays, interruptions, or cancellations in traditional healthcare studies, demonstrating their potential to enable clinical trial participation from the comfort of participants’ homes.
Although there are many benefits to decentralised studies, the clinical trial sector faces challenges with effective management from offsite locations.
From the reliance on effective clinical trial packaging and labelling strategies to the legitimacy of results data, research can always be compromised. That is, unless we protect the integrity of samples and the precision of their associated collection methods.
Throughout this blog we will explore the opportunities decentralised clinical trials offer, as well as the challenges faced, and how many of these can be overcome through the introduction of innovative kitting technologies.
The importance of decentralised clinical trials
Decentralised clinical trials are leading the way in remote research participation and at-home sample collection. Pivoting from traditional, site-based trials, DCTs offer many benefits. First and foremost, they remove the need for extensive travel, which the National Institute for Health and Care Research attributes this to greater participation rates.
Other benefits of DCT's include:
- Enhanced patient participation
- Increased diversity
- Increased retention rates
- Cost-effectiveness
- Quicker recruitment
As stated by the FDA, decentralised clinical trials and health care technologies often go hand in hand. Digital technologies are leveraged to transform the collection and monitoring of data extensively throughout the entire healthcare supply chain. Accounting for research data collection with emerging technologies will help support study validity and traceability.
Within the studies themselves, the implementation of technology also helps to create a more inclusive and adaptable environment, catering to the diverse needs of modern clinical research. This enables studies to scale from small initial concepts to large-scale investigations involving many participants.
The crucial role of clinical trial packaging and labelling in decentralised clinical trials
The validity of trial results is often cited as the main concern with decentralised clinical trials. However, through the collaboration of clinical trial packaging and labelling, and modern technologies, there are innovative ways to ensure that a trial runs smoothly and produces reliable results.
Enabling accurate sample collection records
One of the biggest challenges linked with decentralised trials is maintaining accurate sample collection records. These records are critical for the validity, traceability and audit documentation of studies and are guaranteed to be requested should a trial progress throughout the Phases.
This is emphasises with longitudinal studies, for example, where repeatedly examining the same individual is a standard requirement. Record history here is paramount.
To tackle this issue, RDi’s fulfilment software uses full camera verification to create an end-to-end audit trail, capturing date and time stamps of assembly as well as coupling participant data which facilitates the accurate record keeping of every action undertaken in associated with a specific clinical trial sample collection kit.
This integrated technology helps to ensure that patient data is accurately aligned with the sample kit throughout the production stages. It allows research institutes and organisations to access analytics and kit data. This is crucial for tracking kits from study participant to lab receival and offers insights into geographical behaviours and participations.
With unmatched traceability on all kits and a tracked path through the supply chain, even its return journey, key operations and compliance are easily maintained.
Mitigating sample integrity risks
A significant benefit of decentralised clinical trials is their ability to offer a more accessible, efficient, and patient-centric approach to clinical research. However, by removing the need to attend a healthcare setting, you’re putting the responsibility of sample collection into the hands of the patient.
Performing remote sample collection puts the integrity of a sample at risk from the offset. Primarily because the participant is in charge of the collection and will likely have no research supervisor present.
Simple changes, such as easy-to-follow instructions printed directly on the packaging, have significantly improved the usability of at-home testing products. RDi has met the demands of market gaps with a variety of our collection kits and devices, which have assisted with bowel cancer screening and urine collection, to name a few.
RDi’s automated camera verification ensures that each traceable kit comprises all components necessary for a safe sample collection and return, from all diagnostic consumables to the primary and secondary packaging. Its complete traceability throughout its journey from home to the lab provides precise timestamps to confirm delivery within the required preservation timeframe.
The next issue that remote sample collection poses is maintaining the integrity of a sample on its onward transportation journey to the testing laboratory. The simplicity of the return instructions and the compliance of the entire UN3373 return packaging are critical factors in ensuring that participants can effectively collect and return samples.
Again, our technology ensures a seamless approach to decentralised clinical trial sample collection, contributing to each trial’s overall success.
Streamlining trial kit logistics
One study focusing on the planning and deployment of DCTs, highlights that opting for a decentralised study requires extensive and effective collaboration among multiple parties within the supply chain.
We recognise that successful DCT’s introduce new tasks, responsibilities, and time commitments for a clinical trial organisation. Travel burdens, for example, can present as an extra challenge, potentially increasing the strain on resources and staff.
RDi’s unique automated supply chains and clinical trial kitting production have been designed to combat such challenges. Using clinical trial kit transportation as an example, RDi applies automated segmentation to pre-sort kits by location, minimising delays while reducing the need for additional courier trips.
By optimising the logistics process, RDi ensures that trial kits arrive at their destinations on time, maintaining study momentum and complying with the collection program.
Businesses can also take advantage of real-time analytical insights, tracking systems and behavioural insights drilled down into geographical concentrations, allowing you to identify and utilise intel for future planning.
Choosing the right solution for you
Decentralised clinical trials often require kit designs tailored to specific study needs. A one-size-fits-all approach isn’t often effective, given the diverse requirements of each trial. RDi tackles this challenge with personalised kits, where the elements and components that are assembled are suited to the unique demands of each trial. With our custom medical packaging solutions and industry expertise, we can also help balance your needs with UN3373 packaging requirements.
With the capability to produce hundreds of different kit variations with full traceability, RDi ensures that each kit is designed to meet the specific needs of the trial. This flexibility ranges from individual components to primary, secondary and outer-packaged kits.
A significant advantage of decentralised trials. Is the ability to support studies and assist with scaling trials from initial stages to large-scale investigations.
RDi’s innovative kitting and clinical trial packaging and labelling solutions are designed specifically to accommodate scalability, with the capability to produce more than 150,000 kits a day.
By providing 100% compliance guaranteed kits, and leveraging our expertise in data processing, technology and automation, we deliver a supply chain that is capable of adapting to the evolving needs of large-scale studies.
Conclusion
Decentralised clinical trials represent a significant advancement in clinical research, with improved participation rates, innovative remote sample collection kits entering the market, and testing laboratories demand improving, too.
The logistics of DCTs has shown to be heavily dependent on effective kit assembly, fulfilment, transportation, packaging and labelling, sample collection and re-packaging. All of which are accounted for in our clinical trial kitting solutions.
Decentralised clinical trials are set to drive significant progress in research and treatment, ultimately improving outcomes for patients worldwide, and we’re proud to be playing our to support a new arm of clinical research.
Our sample collection kits are pre authorised for regulatory compliancethrough a standardised kitting approach. Automated production lines ensure safety and quality standards are met, and our unique assembly technology allows each kit to be QC checked on an individual level.
We will continue to implement sustainable practices into our kit components, embedding our deep understanding of the clinical research sector and its surrounding mission into our practices. Partner with RDi to minimise lead times whilst gaining quality assurance.
