Sadly, March Madness is now over, but that doesn’t mean the madness in clinical trials is over! The past two years have been transformative – not only in our personal and work lives, but in the clinical research industry as well. Imagine just a few years ago, when the industry was discussing virtual clinical trials and it felt like an aspiration. Yet, the pandemic pushed the concept into fast forward, and here we are today, where the biggest buzzword in clinical trials is decentralized trials, a term that may have not been fully defined just a few years ago.
We recently conducted our Mednet Madness poll to survey the industry on the current trends. Tournament brackets are probably not the best way to conduct surveys or research, and it’s fair to say it wasn’t exactly scientific, but the results aligned with findings we’ve seen in other surveys and across the industry. We released the ‘bracket’ with our ‘Sweet 16’ of clinical trials trends, asked voters to whittle it down to 8, and late last week we released the ‘Elite 8’ for voting to the Final Four, Championship, and ultimately, the winner.
The voters determined the ‘Final Four’ trends as 1) Remote Monitoring, 2) Decentralized Trials, 3) Patient at the Center and 4) Hybrid Trials. These trends are all aligned with things we’ve all been seeing and hearing in the industry over the past few years.
The pandemic made it difficult to visits sites in 2020, making regular on-site monitoring difficult, if not impossible. Yet, not every project could be put on hold, and the industry needed to identify ways to innovate quickly. Many research teams leveraged tools and technology to adopt remote monitoring as a means to keep trials moving and on track. In clinical trials, remote monitoring is defined as monitors virtually reviewing and transferring the data, versus visiting the site to do so. With the use of flexible technologies, the CRO or study sponsor can review the data virtually. Our webinar, The Pandemic Push, described how we worked with our CRO partner, MedTrials, to optimize remote monitoring capabilities in iMednet.
When patient recruitment and retention are critical to the success of a trial, patient engagement – or an increasing focus on the patient at the center – is imperative to attract and retain study participants. And, the trend toward decentralized and hybrid trials, coupled with new technologies, such as wearables, monitoring tools and apps, is making patient engagement a growing priority.
Yet, when we think of the patient at the center, it is more than just patient engagement, it is about patients and patient advocates becoming more involved in trial designs. Patient advocates play an important role in research by bringing the patient’s perspective to the investigative and clinical environment, uncovering potential barriers and challenges in advance, particularly as it relates to remote participation and direct data collection. Our blog, An Increasing Focus on Patient Engagement in Clinical Trials, explores this trend in greater detail.
Hybrid and decentralized trials really fall into the same category, and although the term decentralized trials is the big buzz word in clinical trials today, hybrid trials are truly more realistic and common. As a blend on the continuum between traditional and decentralized trials, the hybrid format enables clinical research teams to dip their toes in the water and begin to understand the implications of partially remote tasks and activities before committing to a fully decentralized model. At the same time, some clinical studies, like device trials, aren’t necessarily suited for a fully decentralized model. Hybrid trials enable clinical trial teams to customize the trial and mix traditional and virtual designs in a unique way that meets the needs of the study design and requirements, while also improving access for the patient.
Fully decentralized trials, sometimes referred to as remote, site-less or virtual clinical trials, are defined as the traditional physical site being replaced with either a “direct-to-patient” model or a virtual site model. In these types of studies, patients remain at home during a significant portion, if not all, of the study, and technologies, such as wearables, personal devices, and other tools capture, store, and report patient data traditionally collected at a trial site. Visits to a primary site are replaced with remote data collection directly from the participant and / or visits with a telemedicine or a local / mobile provider. In some cases, home health nurses make patient home visits, evaluate patients and administer drugs. Automated data collection can improve data quality by removing the human element, capturing data in real-time, and delivering it back to the sponsor or CRO. In addition, a variety of technologies also deliver real-world data, providing researchers with a greater understanding of the real impact of lifestyle and / or other factors on health outcomes and efficacy of investigational treatments. Our recent whitepaper, Decentralized Trials: A Flexible Continuum explores the opportunities with both decentralized and hybrid trial models.
At the end of the day, our ‘championship game’ was a match-up of something akin to two conference rivals, hybrid and decentralized trials. While it wasn’t quite as exciting as the game between the Kansas Jayhawks and the University of North Carolina Tar Heels, Decentralized Trials was ultimately crowned the 2022 champion!
iMednet is designed as a flexible technology to enable teams to swiftly adapt to the rapidly evolving requirements of clinical research and efficiently manage data for a wide range of study designs and formats. To learn more about the iMednet platform and how Mednet is adapting to trends in clinical trials, contact us.