Essential learnings: How do I begin…?

As a statistician, you can – or maybe you should? – play a major role in benefit-risk assessment…

As a statistician, you can – or maybe you should? – play a major role in benefit-risk assessment of medicinal and healthcare products within (and beyond) your organisation. Many asked us, “where do we start?”. Fortunately, there is a vast amount of research and numerous initiatives developing, applying, discussing and championing the use of more structured benefit-risk assessment. The unfortunate part is back to the said question, “where do we start?”.

pst1690Let us first respond to this question by pointing readers to an article published in late 2015 in the journal Pharmaceutical Statistics. The authors presented a starting point to learning about BRA with many references, especially if you are new to the field.

Why should (nearly) every statistician know about benefit-risk assessment?

 

Benefit-risk assessment is at the heart of what our industry is all about.

A physician will only prescribe a treatment, if he is convinced that the benefits outweigh the safety concerns. A patient will only take a medication, where he trusts, that the treatment works and the side effects are less important than the anticipated help. And finally, of course a treatment will only be approved if the regulatory body determines that there is more to gain for the patients than to loose.

These things are really clear to everybody, but