Despite all the hardships and stress that the Pandemic has caused, there have been amazing advancements in clinical trials that have come from the chaos. This article focuses on the interconnection of people, processes, and technology and how they not only have helped each other to evolve but how the need for rapid advancement drives the shift between them towards developing technologies for the future.
WHAT IS DIRECT-TO-PATIENT LOGISTICS?
Direct-to-Patient Logistics (DTP) is 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 reducing the cost of the trial 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. Many times, one site did not perform and as a result, statisticians often had to struggle at the end of a trial to ensure that the statistical power of the study wasn’t at risk due to incomplete use 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 answer came in the shape of the implementation of the first Interactive Response Technology (IRT) systems.
Soon after IRT’s inception, more questions were asked and IRT would go on to eliminate many manual processes and in turn, promote further advancements in not only trial design but supply chain processes as well. 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. The system evolved to control who was assigned 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 not only triggered the evolution of technology and processes, but also the evolution of other roles in a clinical trial sphere. With data at the core, the role of a data manager has evolved into a data scientist role. Thus, the interplay between people, processes, and technology is a powerful connection that continues to influence the steady evolution of clinical trials and the industry. The advent of decentralized trials, with direct-to-patient logistics, embodies this as well. It started with placing a focus on putting patients at the center of the trial which went on to inspire the evolution of the Internet of Things and triggered fundamental changes in trial processes such as conducting visits through telemedicine and delivery of medication through direct-to-patient logistics.
GETTING PAST THE BARRIERS
Sometimes evolution is slower than we expect. Direct-to-patient logistics before Covid was 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 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 the progress in promoting the practice. The perceived challenges to DTP at the time were interesting as well. They included things like the loss of cold chain control or the risk of patient adherence as roadblocks to widespread adoption. The reality was however these same roadblocks proved to be where DTP provided the greatest benefits as we now know it today. This shift in perception is largely due to the need for change in process and advances in technology.
Regardless of the new implications and considerations, the benefits of implementing DTP methodology far outweigh its challenges. The advancements in DTP have allowed for emergencies to continue patient treatments and provided more freedom to trial participants to move freely while participating in trials and still receive their clinical supplies. For example, patients can now consider long vacations and not risk discontinuation of treatment in the clinical trial. These benefits have helped tremendously with the recruitment and retention of patients because it supports patients to participate wherever they are and not just where the clinical sites are. The ability to conduct DTP shipments was a key factor in the movement toward decentralized trials. Either fully through telemedicine or in combination with on-site visits through a hybrid approach, decentralized trials have quickly become a go-to option where it had once only been seen as an option in limited cases. Now, the ability to enroll more patients and reach those that might otherwise have a difficult time participating in person, either by where they live or by the nature of their disease state, is paramount in any new trial’s success.
Fully decentralized and hybrid trials have proven to attract, retain, and serve patients more effectively than standard trial models and reduce costs with fewer sites, fewer physical monitoring visits by CRA’s, and limited patient and clinician travel. As a result, clinical trials have finally begun to move to the next level of patient retention, efficiency, and innovation.
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