Abstract
Patient adherence to the protocol in clinical trials is a critical factor in determining the outcome of the trial.
An investigational eFlow nebulizer was used with an eTrack controller featuring adherence-monitoring capability (PARI Pharma, Germany) to deliver drug to the lungs via inhalation and to objectively monitor adherence. The inhalation data were available via the PARItrack web portal and allowed evaluation and graphical visualization of each patient’s adherence.
The clinical trial involved 10 patients who self-administered drug in their homes twice a day for 6 weeks. The eTrack controller automatically transferred data of each nebulization via a Bluetooth connection to a 2netHub (Qualcomm) and via GSM to a server. The data could be accessed through the PARItrack web portal. The clinical trial nurses, investigators and CRO could remotely monitor adherence and an alert system was established for information on missed inhalations. This allowed individual adherence issues to be addressed immediately and corrective actions to be implemented to ensure ongoing adherence.
This setup resulted in a high adherence rate over the duration of the clinical trial. The overall mean adherence rate was 96 %. Seven out of ten patients had an adherence rate of 100 %, two had 95 %, and one had 64 %. This compares with a reported adherence rate of 78 % in the first 4 weeks of another clinical trial using a monitoring nebulizer without remote data access and intervention [Fuchs et al. ECFC 2011].
The high adherence rates achieved in this study demonstrate the utility of remote monitoring and immediate intervention to achieve good adherence in a clinical trial.
- Copyright ©the authors 2017
