Tell us about your career
I was a specialist in Internal Medicine and Endocrinology and worked for 15 years in the public health care system mainly in university hospitals. Later, I had the opportunity to become the manager of a stand-alone clinical research site that was struggling. The site was part of a broader network of sites called CCBR. I was able to turn it around, and the founder entrusted me to serve as CEO. In 2012 the founder supported a growth strategy to globalize CCBR. During this period, CCBR added sites in Latin America and developed China. With the hard work of fantastic colleagues in different geographies, CCBR became a truly global site network. Since 2013 CCBR has been owned by different private equity firms.
At CCBR, what were your major opportunities and challenges?
At CCBR, we sold ourselves as a scientific, integrated PI network to global companies, including many U.S. based pharmaceutical sponsors. At first, we struggled because many of them characterized us as a "Site Management Organization," which at one point had a bad connotation since many of the SMOs in the early days were only doing business development, not operational management.
Our scientific background and processes helped us to differentiate ourselves from that prior model. We emphasized the standardization of our operations across sites, which was essential to upscale our network in a relatively short time frame. I used to think of CCBR's mission with respect to research as Starbucks' with respect to coffee: No matter what store you go into, the quality of the coffee is the same. For CCBR, this was quite an accomplishment because we were operating in a wide range of countries, with different languages, health care systems and cultures. In this context, we also benefited from being a member of the Society for Clinical Research Sites (SCRS), which provided all our clinic staff with access to online education and training independent of geography.
We weren't the only ones doing this in EU. Synexus was doing the same thing at the same time. But the site market has always been so fragmented that we never considered each other as competitors. It's such a big market out there with lots of opportunity for everyone.
And now, "site management organization" seems to be an OK thing to label oneself
Yes, the term is not offensive any more. However, at the end of the day, the most important thing is to define how you want to present yourself to the marketplace--you need a clear statement of what your definition of value and delivery is all about.
You have a specific and thought-provoking vision for the future of research. Tell us about it
First off, I don't believe we will eliminate the role of the local investigator, at least in the foreseeable future. You will always need a physician/specialist who is local to the patient to perform physical exams and provide safety oversight. The patients entrust their physician to make the right decisions and recommendations on their behalf and the PI will also, in the foreseeable future, be the patient's advocate to ensure their safety and well-being.
That said, I think we're at the point where we can almost eliminate the concept of a physical site facility. Of course, you need a place to work, see patients, store IP, etc., but now, if we can incorporate the right technology, we can do a lot of the data collection remotely. That means that while the PI will remain to perform needed in-clinic visits, we can foresee more at-home visits and more remote visits taking place within a trial. What will make this happen is an end-to-end technology solution, from e-consent through data collection.
So, technology can replace the need to have a dedicated facility. More research can be done by specialty clinics as technology will reduce the physical workload on the clinic and clinic space dramatically. With more of a plug-and-play model, you could envision a larger, more dispersed network of specialists with interest in different kinds of research areas, who can participate as needed. These specialists don't need to have a large investment in local resources or infrastructure.
What that means for sponsors is that they can tap into the energy and interest of the many specialists out there who have an intellectual, but not necessarily financial, interest in performing research. And particularly for some indications, such as rare disease or some of the highly specialized indications, being able to tap into that very broad pool of physicians with access to the right patient population is critical. For high paying specialties, in particular, the financial incentive to do research is minimal. So engaging with these investigators on the level of scientific interest is critical.
A missing piece is the link between the Sponsor/CRO and the specialists/PIs. Current models are often not consistently effective and are one of the major causes for the study delays seen in most indications. Engaging with an independent academic research provider, who has a profound understanding of both sides' challenges and needs, is critical to achieving good, consistent performance.
We have witnessed this again recently with the formation of TrialCare, where we partner with highly recognized specialists and share harmonized workflows to ensure a level of quality in research commensurate with their daily clinical work. As an academic network operator, we share the core values of the specialists, which are to represent the interests of the patients and to put their safety and well-being as the highest priority. This also means that we only engage in sponsor funded research that can truly benefit our patients.
We work as the overall research umbrella, offloading a lot of the site administrative work with the assistance of technology. However, even with technology, a lot of specialized knowledge is required to run a trial efficiently. So there's a role for a sponsor-independent site operating partner with the roots in academia--perhaps call this the next version of the SMO model--who can partner with and quickly activate these specialists. These academic site operators will be well-positioned to encourage these specialists to professionalize their engagement in pharmaceutical and medical device sponsored research. These operators and the sponsors/CROs can work more closely together, bridging critical gaps that are currently responsible for delays and insufficient performance of sites.
In this context, the right technology will move us toward an integrated end-to-end solution and increasingly enable us to minimize the workload of the sites. Having specialists to concentrate on the care of their patients will become more important. In parallel, as a member of SCRS, the site's staff will have access to a growing range of online education and training. Ultimately, sponsor funded research will then fit into the daily routine and become a natural and integrated part of a clinic, not a disruption.
This is a big vision for the industry. But the industry changes slowly?
Yes, definitely. The pace of change is slow, but everyone has the common goal to provide better treatment opportunities for the many patients in need. If you want to build a site network, or research operation, like we are doing with TrialCare, with this kind of framework in mind, you have to do so carefully and not grow too prematurely. That said, I think everyone should start thinking about a world of research where the elements I laid out are in place, and in that world, ask themselves how they are going to offer value.
From 2011-2017, Dr. Hans Hoeck served as CEO of CCBR, a 20+ site global research network that randomized 20,000 patients across multiple indications and was later acquired by a private equity firm. Under his leadership, CCBR built a significant site network in China covering participation of 250+ hospitals in 55+ major cities. Currently, Dr. Hoeck is CEO of TrialCare, an academic research institution with a unique vision for research. Prior to becoming CEO, Dr. Hoeck served as Managing Director of a major research site and as an academic physician. Dr. Hoeck received his MD from the University of Southern Denmark and his PhD from the University of Copenhagen.
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