CASE STUDY
-
Assignment period: 5 months
-
Locations: 1 site
-
Flying Research Professionals deployed: 1
-
Hours worked: 390
Summary
Camovis supported the Zentralklinik Bad Berka with a Flying Research Professional for a randomized, double-blind phase 3 study to evaluate the efficacy of an innovative drug for hypercholesterolemia. The assignment lasted five months and comprised 390 hours.
The drug investigated in the study, MK-0616, belongs to the class of PCSK9 inhibitors. These drugs inhibit the PCSK9 enzyme in the liver, thereby preventing the breakdown of LDL receptors. This preserves more receptors, leading to a more effective reduction in LDL cholesterol levels. While injectable PCSK9 inhibitors are already approved and have been shown to significantly reduce LDL-C levels, MK-0616 is the first orally administered version of this class of drugs to be tested.
Challenges in the original recruitment plan
Patient recruitment was competitive, and the Flying Research Professional was tasked with helping the clinic achieve its recruitment targets. Initially, the plan was to recruit patients from the inpatient setting, as had been successfully done in previous studies.
However, this proved to be ineffective, as many inpatients were not eligible for the study due to complex diseases or their overall state of health.
New strategies thanks to the Flying Research Professional’s initiative
Our Flying Research Professional recognized early on that the original recruitment strategy was not delivering the desired results. She took the initiative and worked with her local contact to develop new, targeted approaches. Thanks to her experience and commitment, the focus was expanded to include cardiology and gastroenterology outpatient clinics. She also initiated the distribution of an internal clinic newsletter to recruit potential study participants through employee referrals.
Recruitment target achieved
Through the proactive involvement of Camovis and the close collaboration with the study team, 12 patients were screened, nine of whom were randomized for the study. This was a significant contribution to achieving the study's goals, especially given the initial recruitment challenges.
