http://type2diabetestreatment.net/diabetes-mellitus/the-brains-behind-coordinating-diabetes-research-at-jaeb-center/
When a new product or medication finally makes it to market and into the hands of PWDs (people with diabetes), we often forget about the monumental effort it took to it get there.
The necessary research and development, clinical study coordination and regulatory review is a complicated and very detailed process that takes years to complete, and most of us patients never get to see.
But do you ever wonder who the brains are behind getting all that research from Point A to Z?
Say hello to the Jaeb Research Center for Health (JRCH), a key national player in coordinating clinical research and assisting in the development of new products, treatments, and even cultural shifts in how we manage diabetes.
From its headquarters in Florida, Jaeb coordinates multiple studies per year at 75 participating clinics in 33 states around the country, including Stanford University in California and Henry Ford Health System in Michigan, to name a few. The staff consists of 26 epidemiologists and statisticians, 34 IT people, 13 protocol monitors, 20 project research employees, and 10 executive management positions. At the moment, the center is managing four eye disease and six diabetes studies -- all with human subjects, of course.
One leader in the D-research world refers to the Jaeb Center as "the engine required to support clinical research."
"For most people with chronic diseases, it"s difficult to appreciate the complexity and challenge of R&D. There"s an incredible amount of work and technical effort in protocol and regulatory side of these clinical trials, and Jaeb is an expert in delivering all of that," says Dana Ball, head of the influential T1D Exchange, a non-profit that supports T1D research through a grant from the Helmsley Charitable Trust.
The Story Behind Jaeb
The JCRH in Tampa, Florida, is itself a not-for-profit that’s been around since 1993, and the man heading up the R&D coordination hub, Dr. Roy W. Beck, has a very personal connection to type 1 -- his son Andy was diagnosed at age 12 in the 90s.
Before Beck became a D-Dad, was an ophthalmologist practicing at the University of Michiga
n. Eventually, he started getting involved in clinical trial research and moved to south Florida in the late 80s, pursuing research and funding from the National Institutes of Health (NIH). But as he says it, the “bureaucracy became too frustrating” and he decided to go off on his own.
Beck created a separate non-for-profit center, naming it after his three children. JAEB is his children’s initials in order of their age – Jody Andy Eric Beck. It’s the A who has T1, he notes.
He managed to secure several NIH grants relating to eye disease, including that first one in 1995 for studying an inflamed optical condition related to MS (multiple sclerosis). That research and clinical trial coordination for eye disorders was where Jaeb started, before diabetes came into the picture when Andy Beck was diagnosed.
“After a few years of being a parent living with this every day and learning all about it, I was able to tell people that I had my diabetes fellowship at home,” Beck says. “Those were the days before widespread Internet, and we really knew nothing about the practical side of type 1 in children. So after a few years, I decided to use my time and center’s resources to work on studies for type 1 diabetes, because of that personal connection and because I felt like I understand that from the perspective of a statistician and epidemiologist.”
What Does Jaeb Actually Do?
The center"s all about the design, implementation, and analysis of clinical trials for eye disorders and type 1.
When companies are researching new medications, products, standards or treatment options, there"s a whole host of nuances that have to be managed -- from vetting all the sites and doctors to be sure they all have the necessary credentials, to creating the protocols for how the studies will be conducted and data analyzed, to how that will be compiled to prep for FDA regulatory review. Here"s a look at their to-do list:
- Ensuring funding for the studies
- Coordinating everything at each research site
- Generating all the necessary forms that outline the study and its procedures for review by the doctor
- Determining how data will be collected and analyzed in a particular data management system
- Developing protocols for how patients will be selected and randomized
- Making sure all of the needed devices and supplies for the study at each site are coordinated
- Quality assurance and statistical analysis of everything involved
- Writing the manuscripts and research articles for scientific meetings, which play the important role of spreading word about the research throughout the medical community
Handling all this behind-the-scenes work, the center may be considered the unsung hero in many research trials. Obviously, it"s not involved in every study. But it has a pretty impressive track record on all the projects it"s participated in through the years.
Beck says while Jaeb was well-recognized nationally in eye research in those early years, he didn’t know the diabetes researchers very well. But roughly around the start of the new century, he applied for an NIDDK program during a call for new research projects across the U.S. in 2001, and that first venture into diabetes led to what is now known as DirecNet, a network designed to study glucose monitoring tech in T1 kids.
You name it, Jaeb has snagged some funding -- including big diabetes money-handlers in research like Helmsley, JDRF, ADA and the NIH (among others).
Several years ago, Jaeb aligned with the T1D Exchange that"s also funded by Helmsley Charitable Trust. You may remember the headlines on how Helmsley donated $26 million to Jaeb in 2010 as part of a three-year funding initiative to create a network of clinics in diabetes research. That paved the way for the T1D Exchange Clinic Registry, which is now the backbone of those 75 sites across the country, bringing 27,000 patients into a single research repository.
"We thought we"d get 25 centers, and ended up with three times that many so far!" Beck says. "We have been collecting records on everything from management habits to medications and meals, and we"ve learned an incredible amount from this registry."
One example: learning how electronic health records (EHRs) weren"t effective in collecting data in large part because the questions posed and bits of info collected from patients were not universal.
Ball from the T1D Exchange describes Beck as "chief study architect," for all he does in coordinating these research efforts in multi-site studies.
"If you"re one investigator with 10 people, it"s easy to do," Ball says. "But if you have hundreds of people in critical studies spread out across the country, it takes an architect"s mind to really understand what"s needed to develop the questions and gameplan for this research. That"s a very complicated problem."
Based on this expertise, Jaeb has been involved in a number of important diabetes studies through the years on children and adults, investigating:
- Technology to understand insulin management during exercise
- Managing snacks overnight to combat hypoglycemia
- Brain imaging to determine the effects of hypoglycemia on cognitive development
- Outcomes of CGM technology in schools, with the aim of improving how insurance companies would cover that technology. (They did the first-ever study to show how CGM can actually improve outcomes)
- Artificial Pancreas and closed loop research, including groups involved with the Bionic Pancreas and iLet closed loop device among others. (This has been the largest area of growth for Jaeb in the past decade)
- Severe hypos in older adults, which they found were more common that in other groups -- this was presented at conferences over the past year to illustrate why CGM can be an important tool for those on Medicare
- Racial disparities in the care and self-monitoring of people with diabetes
- Metformin use in teens with type 1 who are on insulin
Some serious diabetes expertise, indeed! And that"s just a taste of what Jaeb has done so far.
Locemia’s Intranasal Glucagon
Most recently, a product of the Jaeb and T1D Exchange partnership materialized into big headlines; news broke Oct. 9 that Lilly acquired Locemia Solutions intranasal glucagon, being developed to replace the overly-complicated mixable emergecy glucagon injection that"s been around for years.
We’ve reported previously on this glucagon you sniff up your nose, and I"ve had the fun of participating in one of the clinical studies of this novel new powdered glucagon!
While Locemia is just finishing up pivotal Phase III trials, Lilly now holds the worldwide rights to eventually distribute, market and sell this new product once it gets through the FDA.
Jaeb was the coordination center involved in this research, and Beck and Ball tell us that when they first heard about the Lilly acquisition, they texted each other exchanging just two words: "Good job!"
Now, Ball says they"re looking forward to "finding the next Locemia -- incubating and accelerating the development of what"s next."
Why Does It Matter?
It’s tough enough to get people interested in diabetes research, let alone get enough patients involved directly. For many years, I resisted the urge to sign up for clinical trials because I didn’t see any immediate "return on investment," i.e. no tangible result of my participation.
But over the years, I’ve grown in how I think about diabetes research. It really is about the greater good and future generations, even if there won"t be any immediate, tangible benefits for me (other than special attention by experts and sometimes free supplies).
Time and again over the past few years, I’ve had friends pass along info about a particular research project that may be of interest... And now, knowing the story behind Jaeb definitely makes me feel more invested in future studies. I like that can see the center’s name now and know, “Hey, that’s the D-Dad who named his not-for-profit research hub after his three kids!”
Disclaimer
This content is created for Diabetes Mine, a consumer health blog focused on the diabetes community. The content is not medically reviewed and doesn"t adhere to Healthline"s editorial guidelines. For more information about Healthline"s partnership with Diabetes Mine, please click here.
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