Case Studies

In one study, the instructions for drug administration were printed incorrectly in one of the study aids. CTRP^® discovered the error and notified the sponsor. Despite the fact that correction notices were sent to the study sites, many sites and subjects continued to follow the original instructions. CTRP actively worked to communicate the correct administration method to the sites and patients and ultimately saved the sponsor thousands of dollars in data that would have been lost due to subject noncompliance. Because CTRP are in direct and frequent contact with the sites and all subjects, they are able to identify issues before they become a problem, communicate messages quickly to all parties, and thus improve the quality of the clinical trial data.

In another study, seemingly straightforward instructions for medication use turned out to result in subject non-compliance. The instructions indicated that the doses be taken in the morning and at dinner. In some parts of the country, "dinner" is a meal consumed in the daytime. Therefore, some patients were taking their second dose of medication around 12 PM while others were taking it around 6 PM as intended. CTRP noted this discrepancy and immediately alerted the sponsor, sites, and patients, thereby averting it from adversely affecting the study results. Without CTRP on staff, it is likely that the sponsor would not have detected the issue and would have continued to use similar instructions in subsequent protocols.