Training

Comprehensive training and peer-based guidance are indispensable to develop and maintain capable risk assessment competences.

Clinical risk assessments and benefit-risk appraisals should contain the following essential elements:

• Consistency—Issues having similar facts should produce generally similar conclusions.

• Objectivity—Reasonable people can differ. It is critical that risk assessment processes support the development of professional medical and toxicological opinions that tolerate the scrutiny of outside reviewers. While the reviewer might disagree with the professional judgment expressed, the assessment should be seen as appropriately incorporating the relevant questions.

• Non-conclusory approach—The professional opinion must be one that arises from the totality of the available information. Stating a conclusion and cobbling together facts to support that opinion is a process that can never be objective or consistently applied.

We can help: Developing processes and procedures; identifying the critical clinical issues; and furthering critical analytical thinking and writing skills are essential to creating internal capabilities in clinical risk assessment and benefit-risk analyses. With today’s therapeutic modalities it is crucial to link a priori the drug product and device delivery system attributes with patient outcomes.