Good Epidemiology Practice Guidelines Committee*

The Committee on Good Pharmacoepidemiology has been active on two high priority tasks charged by the Board: Updating the Good Pharmacoepidemiology Practice Guidelines, and launching the development of Risk Management Guidelines.

Good Pharmacoepidemiology Practice Guidelines — Your opportunity to comment

Revisions have been made to expand the scope of the guidelines and tailor them more to the field of pharmacoepidemiology. As members may recall, the prior version was written explicitly in response to a challenge issued by Dr. Bob Temple of the FDA at the ISPE annual meeting in Washington in 1993. When questioned by the epidemiology audience about why results of pharmacoepidemiology studies were not perceived to be credible by the FDA, Dr. Temple mentioned that other areas of importance in the regulation of therapeutics had long-standing practice guidelines which helped assure quality and accountability (e.g., Good Manufacturing Practice Guidelines and Good Clinical Practice Guidelines), which he pointed out were lacking in our field. Hence, the rapid development and US scope of the original guidelines. The new guidelines are international, with links to other relevant documents (e.g., ICH, CIOMS, ICMJE and CONSORT) and they explicitly embrace risk management and pharmacoeconomics in addition to the traditional area of pharmacoepidemiology. A new section addresses regulatory reporting of potential adverse events associated with therapeutics arising from epidemiology studies, an issue faced frequently by pharmacoepidemiologists.

So — now is your turn to review and make suggestions for revisions to the draft guidelines. The guidelines are posted on the Members Only section of the ISPE website. Comments will be received by the committee chair, Stephan Lanes (slanes@rdg.boehringer-ingelheim.com), through June 30. The Committee will address comments and propose a final version for adoption at the Board meeting in August.

ISPE Risk Management Guidelines — A leadership opportunity for ISPE

At the mid-year meeting in Baltimore, the Committee launched the development of ISPE Guidelines for Risk Management. Elizabeth Andrews chaired the committee meeting attended by over twenty individuals in which the aims of the guidelines were discussed and agreed. To quote Steve Lane’s charge to the group, "ISPE has an opportunity to assume a leadership role in charting the future course of risk management and in describing the role that pharmacoepidemiology can play in this endeavor. To meet this challenge requires that ISPE put forth bold recommendations in support of pharmacoepidemiologic research in the interest of serving the public health. In drafting the risk management guidelines, we should create our vision for the future, and not be constrained by the inertia of the past." Attendees at the meeting in Baltimore embraced these aims, agreed on the specific topics to be addressed, and volunteered to author sections of the first draft by June 15. The ambitious goal of our committee is to present a draft of the ISPE Risk Management Guidelines for discussion among the membership in Bordeaux, with final guidelines anticipated by the end of 2004.

* Paco Abajo, Elizabeth Andrews, Felix Arellano, Susana Perez-Gutthann, Judy Jones, Xavier Kurtz, Steve Lanes, Allen Mitchell, Paul Stang, Anne Trontell, Patrick Waller, and Sue West.

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