Large, multi-site trials are an important part of clinical trial research. They allow for deeper and broader research, while increasing the number of data points. Still, the scale of a multi-site clinical trial can, in turn, scale up the administrative and oversight challenges right alongside these benefits. We need only look to the Journal of Clinical Trials or industry whitepapers to see that challenges like communication, process, and data integrity are ubiquitous and ongoing.
Today, we look at three key challenges for multi-site clinical trials, and how using smart, cloud-based technology for managing their oversight can improve effectiveness and impact.
3 Ways Smart Technology Improves Multi-site Clinical Trial Oversight
1. COMMUNICATION
Instant, reliable communication is paramount to support quality clinical trial oversight, and this challenge is multiplied when there are multiple sites. Those at the site level are dealing with tremendous communication challenges already, and those challenges have the potential to bubble up to the oversight level. The DMC must be aware of these challenges and have tools to properly monitor the communication -- and have good tools and processes for their own internal communication.
Indeed, the DMC needs its own robust, secure, real time platform for communication -- especially in the event of communication challenges or breakdowns outside of their control. For communication to keep up with a multi-site clinical trial, the oversight committees need a single, central, and robustly secure software hub.
Smart software creates a channel for better communication.
2. DATA INTEGRITY
We know that for any multi-site clinical trial, there are many different software solutions managing many different things. This can be a source of challenges for the study. The Journal of Clinical Trials writes that “Researchers conducting clinical trials in multiple clinical sites with targeted populations face significant management challenges to maintain data integrity…” Oversight committees must be mindful of these challenges as they are reviewing data themselves and must ensure that the method and manner in which data is served to them maintains integrity, security and timeliness in order to safeguard patients.
Creating a single, central hub for the oversight of data integrity provides a reliable channel for all data, whatever its source, to be checked in a standardized, formalized way. Even if patient data is being collected in different ways by different platforms and different people, it is being checked and overseen by a single, central set of people on a single, central platform. This reinforces the data integrity of every step of the clinical trial.
Data depends on a single home for efficient oversight.
3. STANDARDIZATION
Oversight standardization is equally critical. With a multi-site clinical trial, the oversight committee is dealing with the added challenge of standardizing the oversight across all sites. This can run into challenges if reporting information or processes is not standardized, or if protocols vary across sites.
A recent whitepaper from Medidata calls out complexity of project management and collaboration as a major challenge for everyone in the clinical trial ecosystem, and added complexity means that the time and energy it takes to maintain proper oversight will increase in kind.
The answer? Standardization of oversight processes and protocols. And while this answer may feel straightforward, it also shines a bright light on how integral a single, secure software hub can be for clinical trial oversight, especially in a complex multi-site study.
Smart software supports smart oversight standardization.
Do your clinical trial oversight teams have the right tools for efficient, effective oversight?
Click here to access our essential guide to the future of clinical trial oversight