High turnover among principal investigators (PI) is well-known in clinical research. In a 2017 survey of 201 PIs, more than half completed only one trial. Most investigators reported four large barriers: workload balance; time requirements (study startup and implementation, and investigator and staff hours); data and safety reporting; and financial issues. Moreover, increasing trial complexity exacerbates these challenges.

Over the years, Frenova has learned a lot about the difficulties physician practices face when attempting to start and build clinical research businesses, and ways to help practitioners overcome these issues and engage in seamless, rewarding research. Here are some of the challenges and solutions:

Barriers and Solutions

No study pipeline
Lack of opportunity is one reason some sites never perform a second trial. However, principal investigators who operate as part of a site network or within a site management organization often enjoy improved access to a pipeline of studies. For example, our business development team regularly uncovers and qualifies new study opportunities and offers them to our partner investigators, who then gauge their own interest and assess their patient populations for eligibility. For dialysis studies, our data-driven prescreening abilities expedite the process by eliminating the need for traditional feasibility questionnaires.

Slow and painful study startup
Study startup is often daunting and filled with inefficiency. Investigators benefit from streamlined procedures to avoid startup delays. To eliminate repetition and accelerate the process, we make use of master clinical trial agreements and a regulatory document database. This practice helps us compress timelines, especially at our F1RST Up® alliance of sites, where we have demonstrated an ability to start studies in half the time of the industry’s average.

Poor return on investment
Physicians are often consumed with managing their practice business and are caught off guard by the complexities of overseeing a clinical research program, especially when it comes to managing cash flow. Help is needed to resolve budget negotiations, manage the books, deal with late payment and collections and handle staff and employment matters — all tasks that can quickly derail a program if not properly resourced.

Frenova offers assistance and training in these areas. For example, our financial analysts are sometimes asked to examine a site’s accounting records to assess uncollected revenue, netting sites tens of thousands of missed dollars. We have also helped many of our partner sites with recruiting and staffing needs, often by leveraging our extensive network of industry contacts.

Time demands
Investigators and clinical care staff must be free to do what they do best — take care of their patients. However, clinical research can bring with it burdensome regulatory reporting requirements, complex data entry processes and systems and time-consuming training sessions and meetings. Frenova encourages sponsors to be sensitive to the time demands on our principal investigators, and work with sponsors to ensure study requirements are feasible in the context of investigators’ daily routines.

Conclusion

Running a successful physician practice business is challenging enough. Physicians seeking to launch and build clinical research businesses often underestimate the incremental challenges and resource demands imposed upon them — especially as study protocols increase in complexity. Expert guidance and support, like that offered by Frenova, can mitigate these challenges and help set the practice up for success when operating a clinical research site business.

See how Frenova maximizes site performance in this case study.

 

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.