Clinical Decision Support Systems: useful for what and for whom?
In his introduction, Eivind Hovig, Professor at the Centre for Bioinformatics, University of Oslo, and Group leader, Institute for Cancer Research, Oslo University Hospital addressed key questions including "What is a good clinical decision support system (CDSS)?" and "Is there any consensus?" He provided an overview of the variety of academic tools and commercial alternatives currently being used and pointed out that
"Clinical decision support systems for the molecular tumor board will have increasing importance, yet they are difficult to evaluate for performance."
The next speaker was Sigve Nakken, researcher at the department of tumor biology at the Institute for Cancer Research. He has developed the open source Personal Cancer Genome Reporter (PCGR) as a reporting engine for clinical interpretation of tumor genomes and the Cancer Predisposition Sequencing Reporter (CPSR). Their purpose is for clinical interpretation of cancer-predisposing variants (being used in ongoing precision medicine trials). In his talk, he gave a comprehensive overview of key precision therapy measures harvested from molecular profiling. He also pointed to challenges, such as the lack of harmonization between knowledge databases.
David Tamborero, senior research scientist at Karolinska Institutet, presented his experience in deploying an in-house clinical decision support system. This system is deployed across a network of European cancer centers. Creating the system posed several technical, scientific, and legal challenges. It also created opportunities to support accurate and consistent decision making, more efficient inclusion of patients to clinical trials, and the use of emerging biomarkers in the precision oncology setting.
The final speaker was Courtney Nadeau, senior researcher in precision medicine at DNV GL. He explained the regulatory considerations for CDSS in light of the new EU Medical Device Regulations (also see previous CONNECT Seminar on the new EU Regulations on IVDR). As he stated,
“IVDR compliance looks like a big task because it is a big task, especially for clinical decision support systems, but there are resources out there to help you get started.”
Detailed information and helpful links to these resources are introduced in his presentation where he specifically highlighted the MDCG (Medical Device Coordination Group), which works as an interpreter for the guidelines.
A big thank you to all the speakers for sharing valuable pieces of their knowledge and insight with us. The full seminar can be seen below.
Comentarios