Decentralized clinical studies are referred to by a variety of names - virtual, digital, - the list goes on. Yet, whatever you may call it matters not; instead it’s the core tenets of this idea that matter most. Here, the inherent patient-centricity of decentralized studies is both the goal and the reward.
For those who may not know, decentralized trials are executed through a combination of TeleHealth and traditoinal in-office settings. Instead of office visits, DCTs often include visits that may be conducted remotely, with patients at home for some or all of the trial.
However, simply arming potential participants with access to or actual apps and devices is not a recipe for success. A clinical trial is, at minimum, an exercise in detailed planning and should always be subjected to a “what if” modeling to plan and to identify what can be prevented or mitigated.
Thus, it comes as no surprise to veterans of clinical trial logistics that the unprecedented challenge of vaccinating waves of Americans with an ultra-cold product was going to be difficult. The decision on how to deploy was left up to states, with seemingly little planning for a central repository to pre-register or track patients nationally.
The goal was to have 20 million vaccinated by December 31st, 2020. The end result, according to Reuters? A much lower 2.8 million.
The reason? According to multiple reports across Reuters, Newsweek, CNBC and others was simple - a failure in planning and communication.
While the Federal government was responsible for, and relatively successful in providing the allocated number of doses to States, progress halted there. A number of key oversights, such as leaving States to plan their own distribution to residents, as well as developing last minute contracts with retail vendors like Walgreens to administer vaccinations have slowed the pace.
As such, Americans have found themselves left in the dark, with little to no information on how to register for the vaccine, where to go, and most importantly, the timeline to vaccination?
So, what’s the lesson to be learned here? That decentralized does not have to mean disorganized.
Clinical trial leaders need to employ the same planning principles that have underwritten successful trial conduct for decades. Proper planning, communication, and room for flexibility are key for all trials - decentralized or traditionally managed. Thankfully, there are several examples in the clinical trial world that sponsors and CROs can look to in order to plan a proper decentralized trial.
New tools in the industry afford us new hope and new access for communities that have historically been denied a chance to participate in research. However, the imperative should be in making all aspects of the study as accessible as possible including thinking through how to communicate, register and prepare participants.
Here in Texas, we are struggling to move into 1B. Houston, one of the largest and hardest hit areas of the US, has been overwhelmed with too few locations offering the vaccine. In fact, many rural Texas counties have not even received a shipment of product. Imagine if we had used the time we had from February until now to create an online registry for people to register, learn about the vaccines, identify accessible locations, and share confidential health information that would help pre-qualify and stratify vaccine recipients. We would be in a much better position today.
Never shortchange up front planning or underestimate the value of communication. It will be the foundation for success.