31 May 2021

Efficient management of complex studies

A web application provides real-time information on relevant study activities.

Where is recruitment well underway, which study centre is facing increased drop-outs, how many patients have already completed the study? All this information has to be gathered laboriously and repeatedly in the day-to-day running of a clinical study. Especially in large, multicenter clinical trials, it is essential for the responsible persons to have a good overview of all study activities at all times in order to be able to take timely control or corrective action.

This was also the experience of the study team of Stefan Engelter's DKF research group. Thus, during the planning phase for the SNSF-supported Investigator-initiated ESTREL study, the idea to develop a dynamic web application emerged. It was to replace the statistics on recruitment and visit status of the individual study centers, which were manually processed by the DKF Data Science Team, and to provide data on the course of the study in real time and visually processed.

The development of an app "from scratch"

The lead developer is Suvitha Subramaniam, MSc from the Data Science team at DKF. At the heart of the application is a dashboard that makes all the desired current information available at any time. The information is presented concisely and graphically, so that the study team can quickly gain an overview of the current status of the study. This saves time and financial resources, and errors can also be avoided during study implementation. In addition, the application is very helpful for new employees who have to familiarize themselves with many different processes when they start work.

The quality of the IT infrastructure is crucial

The requirements for the IT infrastructure to implement such an application are often underestimated. These ensure automated access to specific resources and must meet all data security requirements. The study management app obtains the required data from "secuTrial®", the Electronic Data Capture (EDC) system, which is used as standard at DKF to capture study data.

Outlook: Centralised Monitoring

In addition to its function as a study management tool, the application will also be used as a basis for centralised monitoring in the future. This refers to the control of important study processes and parameters without the physical presence of a clinical monitor at the study centre. Integrating these functions into the existing app is an important component of the development.

The app can also be adapted for other trials in the future. Interested research groups are welcome to contact DKF in this regard.