FDA Draft Guidance on Safety Assessment Committees | Page 2

INTRODUCTION
Because the safety of a drug is of paramount
importance to public health, the systematic
identification and evaluation of unanticipated
adverse reactions, trends and safety signals is
needed for timely and appropriate action.
As a best practice, most sponsors have already
established a form of safety assessment or a method
by which to monitor adverse events and safety
signals. The challenge with analyzing signals and
trends for most companies is the ability to make
decisions based on an imperfectly understood
problem, often using incomplete information.
The FDA has recognized the importance of the
identification, analysis and monitoring of safety
signals and has initiated discussions via a recently
issued draft guidance to recommend ways to
formalize the safety assessment of clinical trials.
Here, we discuss this recent FDA draft guidance for
safety assessment, the definition and purpose of a
Safety Assessment Committee (SAC) and examples
of SAC activities related to safety signals, supported
by an integrated technology platform.
Recent FDA Guidance
The importance of detecting, reporting and acting
upon safety issues in clinical trials has long been
recognized, and the FDA has recommended risk
assessment throughout a product’s lifecycle: early
identification of a potential product, through
the premarketing development process and
after approval.
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However, the recommendations for reporting
unanticipated adverse reactions or increases in
adverse events and reactions are becoming more
formalized. In December 2015, the FDA issued a
draft guidance for safety assessments to support
safety reporting for an investigational new drug
application (IND). Since this is a draft guidance,
FDA has invited review and comment from the
public.2 According to this guidance, the systematic
approach to safety surveillance should include
the following:

ΠUSING THE ENTIRE CLINICAL

TRIAL DATABASE, THE SPONSOR
SHOULD REVIEW, EVALUATE AND
MANAGE SERIOUS ADVERSE EVENT
(SAE) DATA AS IT ACCUMULATES.

 USING UNBLINDED DATA, COMPARE
THE RATES OF EVENTS ACROSS
TREATMENT GROUPS TO DETECT:
a. Increased rates of serious and unexpected
suspected adverse reactions (SUSARs).
b. A clinically important increase in the
rates of known SAEs

Ž PROACTIVELY IDENTIFY
ANTICIPATED SAES.

To achieve these goals, the guidance recommends
that sponsors create a safety surveillance plan
and SAC.