Recommendations for safety planning, data collection, evaluation and reporting during drug, biologic and vaccine development: a report of the safety planning, evaluation, and reporting team.
BACKGROUND
The Safety Planning, Evaluation and Reporting Team (SPERT) was formed in 2006 by the Pharmaceutical Research and Manufacturers of America.


OBJECTIVE
SPERT's goal was to propose a pharmaceutical industry standard for safety planning, data collection, evaluation, and reporting, beginning with planning first-in-human studies and continuing through the planning of the post-product-approval period.


METHODS
SPERT's recommendations are based on our review of relevant literature and on consensus reached in our discussions.


RESULTS
An important recommendation is that sponsors create a Program Safety Analysis Plan early in development. We also give recommendations for the planning of repeated, cumulative meta-analyses of the safety data obtained from the studies conducted within the development program. These include clear definitions of adverse events of special interest and standardization of many aspects of data collection and study design. We describe a 3-tier system for signal detection and analysis of adverse events and highlight proposals for reducing "false positive" safety findings. We recommend that sponsors review the aggregated safety data on a regular and ongoing basis throughout the development program, rather than waiting until the time of submission.


CONCLUSIONS
We recognize that there may be other valid approaches.


CONCLUSIONS
The proactive approach we advocate has the potential to benefit patients and health care providers by providing more comprehensive safety information at the time of new product marketing and beyond.
Crowe
Brenda J
BJ
Eli Lilly and Company, Indianapolis, IN, USA. crowe_brenda_j@lilly.com
Xia
H Amy
HA
Berlin
Jesse A
JA
Watson
Douglas J
DJ
Shi
Hongliang
H
Lin
Stephen L
SL
Kuebler
Juergen
J
Schriver
Robert C
RC
Santanello
Nancy C
NC
Rochester
George
G
Porter
Jane B
JB
Oster
Manfred
M
Mehrotra
Devan V
DV
Li
Zhengqing
Z
King
Eileen C
EC
Harpur
Ernest S
ES
Hall
David B
DB
D001688:Biological Products / Q000009:adverse effects; D035843:Biomedical Research / Q000458:organization & administration* / Q000592:standards; D002985:Clinical Protocols; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards; D003625:Data Collection / Q000379:methods*; D055808:Drug Discovery / Q000458:organization & administration; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control*; D006801:Humans; D015201:Meta-Analysis as Topic; D012107:Research Design / Q000592:standards*; D017751:Safety Management / Q000458:organization & administration* / Q000592:standards; D014612:Vaccines / Q000009:adverse effects
D001688:Biological Products; D014612:Vaccines