The recipe for success when conducting research in a production environment begins with the researcher recognizing and understanding the nature of the clinical care setting and adapting to it as much as possible. Taking the opposite approach, expecting the care setting to adapt to the interests of the researcher, is ill-advised and can negatively impact study timelines.
End stage renal disease (ESRD) patients, especially those receiving in-center hemodialysis, require particular consideration when planning a clinical study in this population. Incident hemodialysis patients, those new to hemodialysis, can be especially challenging to recruit into clinical research studies because their primary focus is on dealing with the lifestyle changes required of new patients. The demands of sorting out medical care and transportation logistics are significant and typically deter these patients from considering participation in a clinical study.
In-center hemodialysis patients in the U.S. typically receive treatments three times a week. This frequency and general predictability of visits to the dialysis center lend themselves well to study visit compliance. However, each in-center hemodialysis session includes an exceptional amount of standard data collection. Sponsors must take this into account when developing case report forms and establishing data entry guidelines.
Researchers also need to consider the two-day (Saturday-Sunday or Sunday-Monday) intradialytic period in their study design. The protocol should align with standard practice as much as possible and accommodate the patients’ normally scheduled visits.
These specifics of the patient care regimen and their impact on the study design and execution can be anticipated. Patient care and logistical considerations can be accommodated by a thorough review of the protocol by a physician in the field who is familiar with conducting research and understands the logistical challenges ESRD patients face. When conducting research in ESRD patients, it is beneficial to have the expert guidance of an organization that is intimately involved with providing care to patients and can help companies conducting clinical studies in ESRD patients to develop protocols that work with and complement the standard practices of 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.