FROM SITE-CENTRIC TO PATIENT-CENTRIC: THE EVOLUTION OF CLINICAL TRIALS AND DIRECT-TO-PATIENT LOGISTICS
In recent years, the clinical trials landscape has evolved significantly. One of the most transformative changes has been the adoption of virtual trials and direct-to-patient logistics. These advancements are reshaping how clinical trials are conducted, improving accessibility, efficiency, and patient engagement.
DIRECT-TO-PATIENT (DTP) LOGISTICS
Direct-to-Patient (DTP) refers to the process by which investigational products are delivered to a clinical trial participant’s location from either an investigational site, central pharmacy, or depot location. DTP helps to attract trial participants, reducing the obstacles to accessing new therapeutic choices and lowering costs by reducing the number of clinical sites and shortening enrollment periods, among other reasons.
EVOLUTION OF CLINICAL TRIALS
Just 20 years ago centralized randomization models did not exist outside single-site trials. Paper envelopes that had emergency unblinding information were sent to each site along with an entire block size of patient labeled medication. It was common for a site to underperform, forcing statisticians to struggle at the end of the trial to ensure the statistical power of the study wasn’t compromised by incomplete utilization of randomization blocks. A simple question was raised: How can we implement a centralized randomization list that could be used across all trial sites? The solution emerged with the implementation of the first Interactive Response Technology (IRT) systems.
Soon after IRT’s inception, more questions were asked. IRT would eliminate many manual processes and promote further advancements in trial design and supply chain processes. The supply chain could start to implement pooled supplies across sites and countries and better control inventory distribution and expiry which then transformed labeling procedures and distribution practices. RTSM systems evolved to control patient assignment to different trial cohorts, enforce dosing titration paradigms, and orchestrate formulation changes. These factors would help to transform trial design thinking and employ adaptive methodologies.
Today, clinical trials employ a variety of digital systems including EDC, ePro, and inventory management systems as well as others that have put data at the center of trial design. This data evolution can all be linked back to a statistician wanting to better manage the randomization schedule of a multi-site trial. This need triggered the evolution of technology and processes, and with data at the core, the role of a data manager has now evolved into more of a data scientist role. This shift further highlights the interplay between people, processes, and technology as a powerful connection that continues to influence the steady evolution of trials and the life sciences industry.
The advent of decentralized trials, with direct-to-patient logistics, embodies this as well. It began with emphasizing patient-centric trials, which inspired the evolution of the Internet of Things (IoT) and led to fundamental changes in trial processes, such as conducting visits via telemedicine and delivering medication through direct-to-patient logistics.
GETTING PAST THE BARRIERS
Sometimes evolution is slower than we expect. Direct-to-patient logistics before the recent COVID pandemic were still somewhat rare within the clinical trial industry despite being established more than 10 years earlier. This was evident in a 2016 survey conducted by Arena International and published in 2017. They asked those in the clinical supplies community how they saw the industry evolving, what was important to them, what they were working on, and what would be next. To put the timing in perspective, this survey was conducted five years after Pfizer published the results of their first-ever virtual trial and two years after the ISPE (International Society of Pharmaceutical Engineers) had published a knowledge brief on best practices in DTP logistics. The survey findings were interesting: only 24% of the respondents reported they were currently working with DTP at the time and a majority reported they were not likely to use it anytime soon.
Most people in the industry were aware of it, but unless there was a niche for it, it was not well adopted. The industry has always had a patient-centric focus, so the advantages of DTP are clearly visible, but the challenges seemed to block progress in promoting and adopting the practice. These included concerns such as losing cold chain control and the risk of patient adherence, which were seen as obstacles to widespread adoption.
However, these very roadblocks turned out to be where DTP offered the most significant benefits, as we understand today. This shift in perception is primarily due to the necessity for process changes and technological advancements.
THE BENEFITS
The benefits of implementing Direct-to-Patient (DTP) methodology and virtual trials are numerous and impactful, far outweighing the challenges. For patients, these advancements mean continued treatment during emergencies and the freedom to move freely while participating in trials. For instance, patients can now take long vacations without risking discontinuation of treatment in the clinical trial. This flexibility has significantly improved patient recruitment and retention, allowing participation regardless of location, not just near clinical sites.
The ability to conduct DTP shipments has been a key factor in the shift toward decentralized trials. Whether fully through telemedicine or combined with on-site visits in a hybrid approach, decentralized trials have quickly become a preferred option. This model allows the enrollment of more patients, including those who might otherwise struggle to participate in person due to their location or the nature of their disease.
For researchers, the use of digital tools for data collection enhances the accuracy and reliability of study data. Real-time monitoring allows for timely adjustments and interventions, improving the overall quality of the research. Additionally, the patient-centric nature of virtual trials fosters a stronger patient-researcher relationship, contributing to the study’s success. Fully decentralized and hybrid trials have proven to attract, retain, and serve patients more effectively than traditional trial models while reducing costs with fewer sites, fewer physical monitoring visits, and limited patient and clinician travel. As a result, clinical trials have begun to advance in patient retention, efficiency, and innovation.
The adoption of virtual trials and direct-to-patient logistics is transforming the clinical research landscape. These innovations are making clinical trials more patient-centric, efficient, and inclusive. As technology continues to advance, the future of clinical research looks promising, with virtual trials and direct-to-patient logistics leading the way. Interested in discovering how Endpoint Clinical can create seamless DTP experiences for you? Schedule a quick demo with us to learn more! Learn more here.
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