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The adoption of virtual trials and direct-to-patient logistics are reshaping how clinical trials are conducted, improving accessibility, efficiency, and patient engagement.
As little as 20 years ago, centralized randomization models were impossible outside of single-site trials. Paper envelopes containing emergency unblinding information were sent to each site along with a full block of patient-labeled medication. Sites often underperformed, forcing statisticians to struggle at the end of the trial to ensure the statistical legitimacy of the study wasn’t compromised by incomplete utilization of randomization blocks. The complications of clinical trial management forced trial designers to think from the perspective of managing a site rather than managing a group of patients.
This begged the question: Could it be possible to implement a centralized randomization list that could be used across all trial sites? The answer came in the form of the first Interactive Response Technology (IRT) systems.
IRTs eliminated many manual processes involved in running clinical trials and promoted further advancements in both trial design and supply chain processes. Better supply chain management allowed for pooled supplies across sites and countries, as well as better control inventory distribution and expiry management. These improvements paved the way for modernized labeling procedures and distribution practices.
Randomization and Trial Supply Management (RTSM) systems evolved from early IRT systems, enhancing their capabilities by integrating real-time supply chain management. RTSM systems improved trial execution by offering greater control over patient assignments within cohorts, enforcing dosing titration paradigms, and managing formulation changes with greater automation. These advancements didn't just streamline trial management—they enabled more adaptive trial designs, allowing researchers to optimize studies dynamically based on emerging data.
Before the COVID pandemic, direct-to-patient logistics were still somewhat rare within the clinical trial industry. A 2016 survey conducted by Arena International (pub. 2017) asked members of the clinical supplies community how they saw the industry evolving, what was important to them, what they were working on, and what they thought would be next.
In 2016, 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.
To put the timing of the Arena survey in perspective, this was five years after Pfizer published the results of their first-ever virtual trial and two years after the ISPE (International Society of Pharmaceutical Engineers) published a knowledge brief on best practices in DTP logistics.
The industry was aware of the possibility of DTP, but lacked a compelling reason to work through the challenges of early adoption and reach widespread institutionalization. Because the clinical trial space is highly patient-focused, some of the biggest concerns included those that would have adverse effects on patients: losing cold chain control and risks around patient adherence.
But great challenges invite great solutions. These concerns turned out to be the precise areas where DTP offered the most significant benefits.
Implementing Direct-to-Patient (DTP) methodologies and virtual trials offer many benefits. For patients, the advancements offered by RTSMs include continued treatment during emergencies and the ability to travel while participating in trials without risking discontinuation. The indirect quality-of-life enhancements DTP provides for patients enrolled in trials also improve patient recruitment and retention, which benefits both patients and trial designers. And because the patients recruited do not need to be based in a single geographic location, there is a broader pool from which to recruit patients.
DTP has also increased implementation of decentralized trials. Because it is possible to combine telemedicine with on-site visits in a hybrid approach, decentralized trials have quickly become preferred with patients who might otherwise struggle to participate in person due to their location or the nature of their disease.
For researchers, digital tools for data collection enhance the accuracy and reliability of study data. Real-time monitoring allows for timely adjustments and interventions, improving the overall quality of the research. And although it may seem counter-intuitive, the patient-centric nature of virtual trials actually fosters a stronger patient-researcher relationship, further contributing to a 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 advanced in patient retention, efficiency, and innovation.
Virtual trials and direct-to-patient logistics are transforming the clinical research landscape. These innovations are making clinical trials more patient-centric, efficient, and inclusive. As RTSM technology continues to advance, the future of clinical research looks promising, with virtual trials and direct-to-patient logistics leading the way.
Are you interested in discovering how Endpoint Clinical’s built-for-purpose RTSM can create seamless DTP experiences for you? Schedule a quick demo with us to learn more!
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