Let’s say you move ahead with a real world evidence study and in six months or a year you find that there is no path forward. It is both time-consuming and a large financial hit for any drug development project. It’s a scary scenario and the number one reason why you should do a smaller feasibility study before you start any big commitments.
A typical feasibility study
When we do a feasiblity study it is most often done in cooperation with you, the developer, and key opinion leaders suchs as physicians and/or authorities. In the most general terms, this is how it’s done:
- Brainstorming session with the drug developer and with key opinion leaders when the confidentiality agreements have been signed. The purpose of the session is to define the problems and questions we need to answer and what data to look into.
- Find out what real world data (RWD) we could get access to.
- Ethical committée application and data application. Regulatory bodies need to approve access to quality- and health authority registers.
- SDS Life Science usually takes full responsibility for communicating with authorities.
- Quality check on the RWD from the registries with the purpose to see if we have received all the data variables we have asked for as well as its richness.
- A statistical analysis to see if we have received sufficient data to draw any conclusions from in this study and eventually in a larger RWE-study.
The end goal of a feasibility study
If everything goes well, hopefully, there is a possiblity to create a study design for a full real world evidence study. This could be an observational study, a safety study or an external comparator treatment study.
How to begin? A first meeting is a good start 🤝
