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Mikkel Lindskov Sachs

Mikkel Lindskov Sachs

PhD Student

Current research

Regulatory Science:

My work aim to include patient risk perception in the approval process of new drugs.

My work focus on rare severe cardiovascular events detected in clinical trials. How to consistently and transparently interpret and assess patient perception of these rare, high impact events is not part of current regulatory practice.

The project has three consecutive domains:

i)  presentation of safety data, accompanied by current expert knowledge, to patients.

ii) documentation of patient risk perception in relation to specific rare adverse events.

iii) communication of patient risk perception to the approving agency.

 

Each domain comes with its own repertoire of challenges - emphasizing the multidisciplinary nature of the project.

Statistics, psychology, pathophysiology, communication and decision making related to both individuals and society are the components of this very first PhD project within the field of Regulatory Science.

ID: 122268675