greater risk than others. If specially planned studies
can help, then the protocols should be outlined.
The final selection should be based on a review
of the ‘pros’ and ‘cons’ and likely consequences of
each option, including the quality and quantity of
any subsequent evidence that would influence the
decision.
The CIOMS V ‘working group’ presented prag-
matic approaches to good case management and
focused on four main topic areas (Lumpkin, 2000;
CIOMS Working Group V, 2001):
Sources of individual cases
Good case management practices
Good summary reporting practices: beyond
PSURs
Determination and use of population exposure
data
The CIOMS VI ‘working group’ moved away from
the realm of post-marketing surveillance, discuss-
ing issues related to reporting of safety during the
conduct of clinical trials and described concepts
important to managing safety information from
clinical trials (CIOMS Working Group VI, 2005;
Stephenson, 2005). The final document includes
discussions of:
ethical considerations for clinical trial safety
management;
good pharmacovigilance and risk management
practices: systematic approach to managing
safety during clinical development;
collection and management of safety data during
clinical trials;
identification and evaluation of risk from clinical
trial data;
statistical analysis of safety data in clinical trials;
regulatory reporting and other communication
of safety information from clinical trials.
The CIOMS VII ‘working group’ is currently
discussing development periodic safety report-
ing recommendations.39.3 ICH initiatives
The ICH was formed in 1989 (Secard International
Conference on Harmonization, 1994; Worden,
1995). It provides a forum for discussions about
the internationally varied technical requirements
for product registration and identifies where mod-
ification and mutual acceptance of research and
development procedures could lead to more eco-
nomical use of resources. Ostensibly harmonizing
only between the United States, the European
Union and Japan, several other national regulatory
authorities send representatives to these meetings,
and the ICH lead is thus followed widely around
the globe.
ICH has various code-numbered committees
and subcommittees, which generate reports on
practical matters. One of these, the ICH E2 work-
ing group, had the goal of harmonizing adverse
event reporting requirements between manufac-
turers and regulatory agencies in the United States,
Europe and Japan; three subcommittees then took
on various parts of this large task, that is reporting
of individual adverse experience reports (ICH
E2A), electronic transmission of individual case
reports (ICH E2B) and periodic safety update
reporting (ICH E2C). In contrast to CIOMS, the
vision of ICH is to lead to the enactment of
specific local regulations; the European and US
regulatory authorities usually adopt ICH reports
verbatim when designing new regulations or gui-
dance documents.
The ICH review process proceeds through five
steps:Step 1:Preliminary discussion and draft report.Step 2: Draft is submitted to three regulatory
agencies (United States, EU, and Japan) and
industry representatives for consultation and
comment.538 CH39 DRUG SURVEILLANCE