12 Questions with the Clinical Trials Network’s Founder & CEO –Dr. Keith Friedenberg
Dr. Friedenberg, thank you for sitting down with us. How did you get started with research?
About 20 years ago I was approached by a pharmaceutical company to participate in a trial evaluating a higher dose PPI for heartburn. I had done a little bit of research during my fellowship, but nothing after. Fortunately, I had a friend who was a clinical trial nurse at a large institution in her previous career and was looking for part-time work. The timing aligned perfectly, and everything just seemed to fall into place.
We know you love research. Was that the case from the start?
It was. I found it extremely interesting as we were exploring drugs and devices that ended up being viable treatment options for indications that never had a treatment. It was exciting to be part of clinical advancements, seeing the impact on patients who finally found relief, as well as helping bring a bunch of new treatment options to market.
In addition to the emotional and intellectual sides of research that I found stimulating, there was the business side. Adding research to our practice also resulted in a substantial new revenue steam that has aided in the overall growth of my practice over the years.
You currently have several partners at your practice doing research. Did they start at the same time as you or follow suit after?
Initially, I was working solo. When my first partner took interest and came on board, my research experience set me apart from other job opportunities he had encountered. That has turned into consistent trend over 20 years that almost all interviewees had a higher preference to our practice because of the uniqueness of having a robust clinical trials program in the private practice setting.
Today I have 4 partners who are physicians that are all participating in research and 5 research coordinators. At any point in time, we might have 20-25 studies going at our practice.
What are some of the larger challenges you ran into when you were starting the research program at your practice?
When I originally started my research program our research coordinator handled pretty much everything relating to research. On top of seeing patients the coordinator would also handle the regulatory paperwork, compliance, data entry into the Sponsor’s electronic data capture (EDC) system, sponsor invoicing/payment reconciliation, marketing and more.
When we were starting out and only had 1-2 studies going, that workload was fine for a single coordinator. When we started getting 3-4 trials at a time a single coordinator wasn’t enough.
Several years in I brought on Chris Petek who came from an allergy clinical trials network. Chris introduced me to a consolidated model in which we delineated tasks, and it worked quite well. One person does the regulatory, one person does the compliance, one person does the electronic data capture (EDC) upload, another person handles the sponsor invoicing/reconciliation and so on.
Out of the model Chris and I formed the Clinical Trials Network. We thought “what if we could have a team that offloads each of these tasks for a research site”. Not only would it be a plug-and-play model that would allow them to obtain instant research infrastructure, but it would also significantly reduce the load of work, making it easier for a practice to add on a research arm.
Today I have 4 partners who are physicians that are all participating in research and 5 research coordinators. At any point in time, we might have 20-25 studies going at our practice.
Were there any other challenges that you ran into when you were trying to get up and running.
Yes, the biggest challenge in research is often finding the patients. There is no predictable pattern, so there are times you are too busy or not busy enough, particularly on the coordinator side. Another challenge is the performance of the coordinators, you must have a coordinator that has a good head on their shoulder, is engaged, and can stay on top of things, because their work is such a crucial role.
Delayed payments are also a very common frustration. You have to accept the fact that you earned it, and you’ll get 100% of what you earned. You may not get it as soon as you want, and that can be frustrating for new investigators.
What initially inspired you to start the Clinical Trials Network?
Another big challenge is getting to a critical mass in clinical trials. When we started out the industry was much more “mom and pop” back then, and it was hard to get on the sponsors’ radars. By the time you found out about trials, they were already up and running. It took a lot of work going on websites, approaching companies you read about, and many calls to find trial opportunities. You really had to carve out a path to create opportunities. Overall, it felt like everyone in the industry was recreating the wheel and it’s still that way today. I started to think “Why can’t we do this together?”
Another major factor was a flaw with the Sponsor’s approach, only experienced sites were brought opportunities and new research sites were excluded. For example, the IBD space has a vast variety of medicines to successfully treat IBD and trials kept coming for new treatments. The problem with only using experienced sites is that you start running out of patients when going to the same research sites over and over. We needed to give new sites a chance to get involved.
Supporting and recruiting new physicians also created greater access to other patients that also need new treatment options. Ultimately, helping trials flow faster and better!
What About CTNX sets it apart from other trial management partners?
CTNx offers one of the widest arrays of trial management and support services, we go beyond just finding trials and negotiating budgets. We have a “boots on the ground” approach and provide constant communication and training. In addition, our compliance program and team is amongst the best. They provide oversight of the work that’s being done and make the process go smoothly and efficiently from the monitoring side. We keep the data pristine for our CROs. Compliance also serves as a training tool for coordinators and physicians.
I firmly believe we are one of the best networks for new physicians to affiliate with. From a financial perspective, we deliver the highest percentage of dollars in the practice’s pocket. And in the end, we’re physician-founded. We think through the eyes of the PI’s just as if we were the ones performing the research.
What has been the most interesting or impactful study you have taken part in your career?
Well, I’d say there have been multiple trials that have been interesting. Particularly I enjoyed the vibrating capsule for constipation, a first-of-its-kind therapy that helps to stimulate colonic motility from inside the body that was approved back in 2022.
I enjoy my studies in IBD, especially the earlier ones that shook up the traditional treatments and allowed me to witness patients get dramatically better. The large volume screening trials are great as we can engage people without diseases into research. Those are just a few off the top of my head.
Are there any specific impacts you felt you have made during your research experiences.
I think the biggest impact is with the more difficult-to-treat diseases. In my opinion, participating in IBD trials for patients with severe IBD and then monitoring them through a long-term extension study is fulfilling. It’s especially rewarding considering the daily impact I felt I was able to make on many people’s lives.
What changes would you like to bring to the industry?
To start I would focus on communications between the sponsors, CROs, and the sites. I would make communications streamlined, simplify the financial processes, and ensure timely payments to the sites completing the work. Unfortunately, delays in payments can hinder site and physician engagement.
Also, the inclusion and exclusion criteria is very challenging, and while much of that is directed by the FDA with good reason, it makes recruitment harder and completion of trials within a reasonable timeline. In selected instances, if practicality could come into play more with the inclusions and exclusions. That would ease the path forward.
Additionally, I’d like to see patients get compensated more. From my experience offering clinical trial opportunities to thousands of patients, the value of someone’s time in today’s world has gone up significantly, and the stipends which are designed to compensate them for their time is too minimal to appropriately thank someone for giving up their time.
How do you think the industry will change in the coming years?
I think like most industries, it will continue its evolution from a “mom-and-pop” industry to a consolidated industry of larger entities. Essentially there will be large companies who own or manage multiple sites (perhaps private equity-backed).
Also, I think that it will continue to get harder to find the patients who fit inclusion and exclusion criteria. Overall, finding patients is expected to become more demanding, and the effectiveness and sustainability of sites relies heavily on patient recruitment.
Do you have any advice you'd want to share for any physicians interested in getting started with research?
I truly believe in the benefit of collaborating with a network, where you are a part of a larger team. This approach saves time that would have been spent on building your own infrastructure and gaining access to opportunities that might otherwise take years to secure and discourage you from hanging in there.
I would make sure that you have an excellent coordinator and be patient with your willingness to learn. Last, be open and accept the guidance from the individuals in the industry that you’ll meet along the way.
