Case Study 1
Blood Disorder Trial
A mid-sized, US-based pharmaceutical company approached ClinStar to rescue a blood disorders clinical study. When ClinStar got involved, 10 countries were enrolling patients, and the client was estimating it would take them 10 years to reach full enrollment. The Russian sites managed by ClinStar enrolled nearly 700 patients, and finished enrollment in eight months.
In addition, the Russian sites managed by ClinStar demonstrated much higher ability to retain study subjects. This same trial required an unpleasant invasive procedure, a venogram, as a measure of outcome. In Western countries managed by other CROs, 56 percent of the subjects dropped out in comparison to only 6 percent of subjects in Russia.
Furthermore, we work hard to help you gather high quality data. When the quality of the first few venograms from Russia was inadequate, ClinStar quickly organized a seminar with Russia's most respected venogram expert for all radiologists participating in the study. We also arranged for that expert to make individual visits at sites. As a result, at the investigators meeting for the follow-on trial, the chief central reader from Massachusetts General Hospital reported that the Russian venograms had the highest quality of any participating country.
The graph below illustrates the enrollment and drop-out rate for this blood-disorder trial.
