Having a well-respected clinician as part of the team to communicate the scientific value of the research gave valuable credibility and comfort level to referring physicians.

 

SITUATION

George Clinical was contracted by a mid-size pharmaceutical company to conduct project management and clinical monitoring in a study to evaluate the pharmacokinetics (PK) and safety of a sulfated oxysterol in subjects with impaired kidney function and matched control subjects with normal kidney function. Phase I of this study was atypical in seeking patients who were already sick, for research on a drug being used for the first time with no prior benefits proven.

George Clinical’s scientific leadership model was a significant advantage in this unique situation. The level of trust created with this peer-to-peer communication model has multiple benefits for sponsors, research teams, participating physicians and patients. The scientific integrity of studies is protected, physicians are more willing to recommend studies when a fellow clinician is on the team, and there is a greater likelihood of recruiting optimum patients for the study who will be most likely to stay engaged to conclusion. In addition, patient needs and concerns are understood and addressed more adequately by those who have been involved in the day-to-day care of people with their conditions.

 

CHALLENGE

Recruitment for this Phase I study was particularly challenging as it was the first time the drug was being used, with no research to show if there would be benefits to using it. Furthermore, recruits would be patients who were already sick. In addition to being inherently difficult to recruit, there was also no adequate financial reimbursement available.

 

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