Mini Educational Series: Planning a benefit-risk assessment using frameworks

Foreword

Frameworks are needed to plan a benefit-risk assessment. Although it may be clear to some people that certain framework has been used when conducting a BRA, it may not be clear to others. In particular, when non-standardised frameworks such as internal (company-specific) frameworks are used.

It is not that these frameworks are not acceptable, but they are more difficult to follow by individuals who do not have access to the detail of the process. Therefore, the use of such frameworks may be seen as a black box to those in the unknown.