The Search for Safety: A Proposed Framework Based upon Insights from Clinical Research

Abstract

Despite extensive investments of time, money, and work by regulatory bodies and the pharmaceutical
industry, there is no widely accepted framework for the evaluation of the benefits and risks of
medications. Not surprisingly, the current frameworks proposed by those two stakeholders are
quite complicated and not readily accessible or understandable by one of the primary, intended
beneficiaries of such information – the patient.
What is desperately needed is a relatively simple tool that can be improved over time and that can be
easily wielded by healthcare professionals and patients alike.
By drawing upon several concepts from clinical research it may be possible to express the benefitrisk
evaluation as a mathematical model, a ratio of four derivable variables.
Frequency x Weight of Benefit (Variable 3) x Disease Severity (Variable 4)
Frequency of Adverse Reaction (AR (Variable 1) x Severity of AR (Variable 2)