[Whitepaper] Prevent the Real World From Derailing Your Clinical Trial: Focus on Protocol Design

Clinical trial sponsors strive to make trials more efficient. However, protocols often fail to account for real-world factors that complicate and interfere with patient and investigator participation. Such factors are especially important in medically complex patient populations, such as in patients with kidney disease.

This whitepaper addresses how to design a protocol that saves time, money, and other resources. Real-world insights covered include:
  • Start with the patient in mind:
    Clinical studies succeed when research needs are balanced with patients’ day-to-day reality and the practicalities of delivering clinical care.
  • Keep the investigator in mind:
    Physicians are key in driving patient recruitment. Considering their schedules and workloads allows for realistic expectations and minimizes extensive processes and repetitive training.
  • Consider the renal research landscape:
    An organization integrally knowledgeable about renal disease patients and their daily lives can help design a protocol that meets the needs of sponsors, investigators, and patients.

About the authors:

Kurt Mussina, MBA
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 Frenova president, he is responsible for building organizational alignment of functions to drive profits and research success.

Christina Kahn, CCRP
As senior director of site alliance management, Christina Kahn oversees all trial activities occurring at research sites staffed by Frenova throughout the life of the trial. This includes oversight of research site protocol adherence, data quality, patient safety, site payment, regulatory obligations to the FDA and IRB, drug accountability, and site performance. She is a central resource for research personnel, investigators, and sponsors.


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