The current clinical research model feels like it is destined to delay the completion of clinical studies. Even if we could solve issues such as low patient participation, the current system we have presents stumbling blocks at every turn to the smooth completion of trials. Why? Because there is little to no consistency from one CRO, one sponsor or one IRB to the next. The current environment is fragmented.
That’s the effect of capitalism, competition, free will and free enterprise, of course — policies and systems are developed and evolve in each organization, and there is usually little incentive to adopt another company’s mode of operation. And, although one might think that regulation in clinical research would lead to consistency and uniformity, in fact, regulatory agencies provide only guidelines — guidelines that are open to interpretation, with interpretation that is often overly conservative. Even though some organizations have promoted standardization and collaboration with innovative visions in mind, their successes have been incremental.
While specific technology platforms may help streamline a particular study, when taken from the investigator’s point of view, the significant differences between software, hardware, policies and processes from one study to the next create an overwhelming tech burden. The research environment today is comprised of thousands of sites and a myriad of clinical trial management systems, eTMF systems, training processes and investigator portals, as well as processes that have little if any interoperability. As a result, investigators must spend significant amounts of time training on each different platform for every study to satisfy individual sponsors. Unfortunately, this tech burden is one reason that has led physicians to leave clinical research.
Incentives for Innovation
Imagine there was one system that everyone used — one that could be integrated across all platforms, systems and processes so technology could be interoperable and duplication of effort and training could be all but eliminated. There would be one login, one input and one easy-to-use dashboard. It would be compatible with all the top CTMS systems, incorporating eTMFs and investigator portals and limiting training. As a result, investigator frustration levels would be greatly relieved.
On the other hand, if there were only one system, a monopoly, where would the incentive be to innovate and drive the health industry forward? As an example, electronic informed consent was virtually unheard of even just a few years ago, but now it’s a thriving market, with competing companies failing and being replaced by new entrepreneurial ventures on a regular basis, each time with improved features and pricing.
The Impact of Mergers and Acquisitions Vs. Competition
Are mergers and acquisitions good for the clinical research industry? Do they increase efficiency? Lower costs? Does the cross-pollination of cultures in an M&A foster innovation or stifle it? In theory at least, merging processes and systems together to achieve economies of scale drives efficiency, with more people using the same technology, processes, approaches and procedures. However, it’s competition that drives innovation, and innovation lowers costs. Is it time to quit thinking in terms of ever-larger CRO enterprises, and instead consider bridging clinical research and clinical care?
About the Author
Kurt Mussina, MBA
Vice President, General Manager
Kurt Mussina brings more than 25 years of international business success to his role at Frenova, including a record of leadership and achievement structuring and orchestrating global business development teams in the CRO industry. As vice president, general manager, he is responsible for building organizational alignment of functions to drive profits and research success. Before joining Frenova, Mussina held a number of executive positions, including as president of Triangle Research Labs; senior vice president of business development for Aptiv Solutions and Nuvilex; vice president of business development and client services for Aptuit; and vice president for global clinical business development for Inveresk, among others. Mussina earned a Bachelor of Science in chemistry from Montclair State University and received his MBA from Duke University, Fuqua School of Business.