Sitting outside the end stage renal disease (ESRD) clinical care setting, you cannot expect to see changes approaching that have the potential to derail your ESRD clinical trial — changes in standard of care; changes in business practice, design and strategy; changes in commercial, government and payer relationships; changes in processes and systems; etc. Only the contract research organization (CRO) sitting within the clinical care enterprise, right at the intersection of research and care, is positioned to see such changes coming and to react to them thoughtfully and strategically.
It is this CRO where you find the recipe for success running a clinical trial in the ESRD patient population. This is as true during protocol design as it is during study execution.
It is only this CRO that has access to the inner operational workings and systems of the ESRD clinical care enterprise. Indeed, no traditional CRO can access the indispensably valuable research assets of the ESRD clinical care enterprise. For example, only a CRO working within the ESRD care provider can leverage the enterprise’s proprietary data assets to best inform protocol design, investigate inclusion/exclusion sensitivities, conduct centralized prescreening of eligible patients and drive patient recruitment in the most targeted manner possible.
Not only is this CRO where ESRD trials are set up for success, but as a sponsor with strategic forethought, you want to partner with this CRO. Why? When was the last time a traditional CRO entered into a commercial relationship with a sponsor to include their new drug product or medical device in the care of the CRO’s patients? That’s right, never. Traditional CROs don’t treat patients. Traditional CROs are not part of clinical care enterprises.
Conducting any clinical research study is an endeavor typically fraught with unexpected challenges. The medical complexities of end stage renal disease patients and the operational intricacies of their care compound these challenges in ways not encountered in any other therapeutic area. The recipe for success when conducting clinical research in the ESRD population requires a partnership with the CRO that sits at the intersection of 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.