A leading global pharmaceutical company was looking for a fit-for-purpose technology and methodology to evaluate the effectiveness of an anti-psychotic drug in terms of relapse, adherence to treatment and patient outcomes.
The complexity of this study came from the fact that it had to be conducted in 19 countries around the world and be adapted to different healthcare systems and languages. We offered a built-for-purpose Electronic Data Capture platform which simplified the data collection for doctors and offered a flexibility that eased study management.
Background
The data was needed to support reimbursement submissions (HTA) around the globe. The company wanted to run the study using its own resources and needed software to help manage the types of site interactions appropriate to non-interventional research. Additionally, it needed to deliver high quality data and keep the doctors engaged for many years throughout the study.
Before initiating the study, Cisiv spent 4 months visiting clinics and hospitals, to gain insights into the care settings, and conducting focus groups. The knowledge from these focus groups enabled us to design the optimum study and technology interface for the users.
Solution
The study was built with multilingual support and a clean and simple data entry process that was not based on a traditional e-clinical model but rather matched more closely with the working practice of doctors. Features were built in to support user communities and sharing of study outputs. Over the subsequent 9 years (2003-2011), this Health Economics study was deployed to 19 countries, 9,500 patients, and 1579 sites, and was run in 8 languages. The study averaged 2 protocol amendments per year across 17 protocol variations.
Outcome
The data from this study was used globally for the lifetime of the drug for ongoing submission of data for reimbursement and to help determine the value of the drug in the real world. This study was cost effective and the feedback from sites was overwhelmingly positive, helping to reinforce the relationship with the pharmaceutical sponsor.
