What is the key aspect that leads to a successful trial? Is it the idea? Or maybe the money? Or is it much more than that?
The process from idea to study protocol and hence to an approved and running trial is not the biggest hurdle in clinical research. It definitely takes time, a lot of work and also some nerves, but once the process has started it is easy to get there. Achieving high quality data, however, is not. So, the biggest hurdle is to handover the protocol to the participating sites, investigators, research coordinators, and study nurses. The aim is to have 100% perfect data at the end of the study and this only by handing over the study protocol.
But this does not work in real life. We are convinced that clinical trial management is the factor with a crucial impact on data quality. Hence, we are trying to optimize our day-to-day management in- and outside a trial.
Standard Operating Procedures (SOPs) help us to standardize our quality at each stage of the project. SOPs are not permanent and need to be updated continuously. Studies Within A Trial (SWAT) are a perfect way to embed quality management within a trial.
Moreover, we are seeking public engagement in order to develop study procedures, especially encouraging patient involvement.
Talking about optimization...
Our primary focus is the conduct of clinical trials, but there is so much more “research” that we do.
One of our current projects is to develop an innovative eMonitoring app that will help us to reduce costs on different ends within a clinical trial.
In addition, we are working on developing and implementing core outcome sets or how to deal with missing data in continuous outcomes.