Before a drug is on the market, it needs clinical studies that provide large amounts of data that will also be useful later on. | © IMAGO / Imagebroker
Given the increasingly data-driven nature of medical research, the idea sounds like a no-brainer: Why not share data from clinical trials? After all, they are a rich source of clinical information, as medical information scientist Professor Ulrich Mansmann explains. This data could then be used much more widely and by many more scientists than those involved in the original study and recording of the data. In principle, the material should be well suited to this purpose. It is generally well structured and clearly explained in the protocols. Responsible shared use of such data holds out great opportunities for increasing the value of medical research and reducing waste. It is no wonder, then, that science and the pharmaceutical industry are working feverishly on models for organizing clinical trial data sharing (CTDS).
For this emerging occupational field, experts from all over the world see the need for specially trained data specialists. To help close this gap, the EU is now funding the SHARE-CTD (“Sharing and re-using clinical trial data to maximize impact”) international network of doctoral researchers within the Marie Skłodowska Curie program. Mansmann, who is Director of the Institute for Medical Information Processing, Biometry, and Epidemiology (IBE) at LMU, is coordinating the project, in which institutions from six European countries as well as the United States and Canada are participating. The network, says Mansmann, will have a major influence on the occupational field with its innovative career opportunities and thus contribute to the lasting use of big data in medicine.
The training will focus on the following key areas: How to prepare data for sharing and how to use shared data; the transparency of clinical trials and reproducible research practices; the technical and legal requirements for data sharing; the quality of data and how to securely handle it. In the first instance, eleven doctoral candidates from across the participating institutions will receive this training.