George Clinical’s Scientific Leadership Model Proves Critical to Meeting Difficult Recruitment Targets in Atypical Phase I Study of a New Renal Drug

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.

Solutions

It is important in situations such as this to be able to work closely with the physicians who could potentially be recommending patients for the study. George Clinical scientific leader and renal clinician Martin Gallagher was able to set up a referral network of five nephrology practices to work hand in hand with doctors who would potentially be recommending patients for the study, engaging them scientifically to make them aware of why this study was important and how it could help advance treatment options in the future.

Professor Gallagher’s ability to communicate with referring nephrologists and give them a comfort level of the importance of the study and the care for their patients during the study was integral in overcoming this challenging recruitment.

Results

With a well‑respected clinician as part of the team to help set up referral networks and communicate the scientific value of the research to participating physicians, George Clinical was able to meet the recruitment targets and facilitate successful completion of the study.

Clients Benefit from George Clinical’s Scientific Leadership Model
The George Clinical Scientific Leadership model offers a scientifically sound, pragmatic approach that informs strong operational delivery and protocol alignment with clinical practice. We provide a framework that enables active peer‑to‑peer communication and action pathways between global scientific committee members, national scientific leaders and principal investigators. Our team possesses a deep understanding of the clinical landscape and emerging trends in clinical practice. The unique insights from a real‑world clinical perspective this adds to studies leads to greater engagement, greater number of sites recruiting, lower screen fail rates and higher retention of patients for our clients, as well as a greater level of comfort and input from participating physicians and recruits.