By Benjamin Ross

May 10, 2017 | 2017 Best Practices Awards | DrugDev, a Pennsylvania-based clinical technologies company, is using their unique identifier, the DrugDev Golden Number, to help pharmaceutical companies and CROs identify locations and personnel for clinical trials by providing universal identifiers across all available data sources.

In the early stages of clinical trials, companies and CROs have a plethora of information on clinical trial investigators and sites, but the data are spread across various systems, both internal and external, and data identifiers shift depending on the company. The result is that companies and CROs are bombarded with the same information but in different formats.

Elisa Cascade, DrugDev’s President of Data Solutions, told Clinical Informatics News that DrugDev was selected in 2012 by a group of pharmaceutical companies and tasked with taking data that was in different formats from different companies and sources, and matching it to a unique identifier that would be the same across all various sources.

The vision was to share data with one another to benefit both the industry and the investigator. If the sponsors had more data, then they could match the right site with the right study, which would decrease the burden for the investigators when filling out feasibility surveys and keep researchers from being buried in unneeded information.

DrugDev seeks more collaboration, not competition, when it comes to the number of data sources within the industry and the solutions created to manage the bulk of that information.

“It’s our opinion that the more people that can use the Golden Number and that can use a standard model, the more efficient clinical trial operations are going to be,” Cascade said. “Why do we need 10 ways to say ‘Phase III clinical trial’? Why do we need 10 ways to tell you that somebody’s medical specialty is neurology? These are not competitive things.”

Industry experts agree. DrugDev’s Golden Number received the Clinical Informatics News Best Practices Award for Study Startup and Design at the recent Summit for Clinical Ops Executives (SCOPE) in Miami, Florida.

Once you have a uniform numerical system across different data sources, you can combine them in an interface and use it for a number of purposes. One purpose is investigator identification and study planning. The idea is that one interface provides all data on clinical investigators that DrugDev’s clients have rights to see.

Another purpose to having this uniform numerical system is in master data management. Within several data sources, you could have one investigator listed under several different name configurations depending on the source’s preference. Dr. John Doe might be “John Doe” in one system, “Jonathan Doe” in another system, “J. Doe” in yet another one, and so on. The DrugDev Golden Number assigns each investigator with an identifying number that will be compatible with all data sources.

According to DrugDev’s entry in the Best Practices Awards, over 30% of global interventional industry clinical trials are now indexed to the DrugDev Golden Number. Cascade said: “We continue to grow the membership because the value proposition is so strong, from an IT perspective with the master data management, as well as from the clinical operations study planning site-identification perspective.”

The next target for DrugDev is online profiles. According to Cascade, DrugDev held a survey and found over a third of investigators have more than three online profiles. “We think it’s ridiculous that an investigator will have to tell every organization, independently, what medical specialty they have, or whether their facility has a -70 degree freezer,” said Cascade. “This is crazy, there’s nothing proprietary about it.”

Again, industry-wide collaboration is the name of the game. DrugDev’s partnerships with such groups as the TransCelerate Investigator Registry, the Investigator Databank, and, most recently, the Association of Clinical Research Professionals (ACRP) display their commitment to relieving the burden of sharing information between companies and clinical trial investigators.  As Cascade puts it: “You share it once, and it’s used by everybody.”