• Sven Jungmann

Clinical study design

Clinical study design is the creation and development of medical experiments or trials for research involving humans. This also includes observational studies of humans in a medical context. Generally, the purpose of clinical study design is to prove safety and effectiveness of a new product or device for regulatory compliance. In a clinical trial setting, this term is used almost interchangeably with clinical trial design.

What innovators need to know about clinical study design:

A medical device or solutions can be a high-risk product, either improving or harming patient health. Studies need to provide accurate, credible, and unambiguous conclusions that can translate to safe use in clinical settings. Thus, design of studies needs to be carefully formulated using appropriate methods to arrive at actionable and persuasive conclusions.

Read more about clinical study design here: https://onlinelibrary.wiley.com/doi/10.1002/ped4.12166

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