The clinical trial landscape is ever-changing. New technology and innovation have changed the way we look at clinical trial design. While we can agree that the recent focus on patient-centricity has been a long time coming, the industry as a whole has struggled with agreeing on how to shift trial designs to be more patient-centric.
There are a lot of confusing terms circulating as they relate to clinical trials – virtual, decentralized, hybrid, remote, siteless – the list goes on and on, but what do they mean from a practical standpoint? Can the industry be expected to switch from a traditional clinical trial model to virtual clinical trials overnight? The answer is this would be wildly impractical, not to mention improbable. The process to move to a more remote or virtual environment takes planning, restructuring, and most of all time.
In the wake of COVID-19, we’re learning the impracticalities of making a virtual trial a reality overnight. So what is the solution when faced with a global crisis? Decentralization. You may be thinking that virtual and decentralized are one and the same, but I believe the definitions are a bit more fluid. While the terms virtual and decentralized have been used synonymously, hybrid trials have also been described as a decentralized trial.
I view a virtual trial as being siteless and fully remote, meaning no or extremely limited physical contact between clinicians and patients. In this model, patients are utilizing remote eConsent, telehealth, and ePRO/eCOA. Researchers and clinicians are using telehealth to communicate with patients, direct capture to record patient observations, and an Electronic Data Capture (EDC) system to store the data.
With a decentralized trial model, I believe there is a bit less rigidity to the definition. I view decentralization as a flexible path. Decentralization is ideal for sponsors and CROs who want to be patient-centric and improve data quality, but aren’t prepared to move to a completely remote model. I like to think of decentralization as a bridge between traditional models and virtual models – a hybrid approach. Decentralization is ideal for transitioning into a virtual environment and while used synonymously with “virtual” nine times out of ten a decentralized trial is what we refer to as a hybrid trial. A hybrid model utilizes any combination of traditional and virtual trial elements.
We recognize that the variety of terms and the nuanced meanings behind them can be confusing and overwhelming. It’s hard enough adopting new technology, why add confusing terminology into the mix? That’s why we developed our Decentralized Clinical Trials Solution to meet the needs of traditional, hybrid, and virtual trials. Our technology is flexible and adaptable to meet your needs.
We also recognize the time and effort involved in the decentralization process. Our professional services team is equipped to provide guidance throughout your process, whether it be moving from paper to electronic data collection or from in-clinic to remote patient engagement.
Additionally, our Global Support team is on call 24/7 ready to answer your questions. Medrio’s Support team really goes above and beyond the call of duty, always putting our customers first. But don’t take my word for it, hear what our customers have to say.