Patient Reported Outcomes Harmonization Group

"Harmonizing Patient Reported Outcomes issues used in Drug Development and Evaluation"



In 1999, four organizations/societies produced supporting guidance documents on the use of HRQL evaluation in drug development:

Following the third meeting, (02/2001), the four organizations agreed to create a PRO Harmonization Group and to meet at regular periods with observers from the FDA and other agencies if possible (e.g. EMEA), and set up a program of meetings with overall and specific objectives (meeting-related).

Representatives from the four organizations worked together in subgroups order to meet a set of prescribed objectives.

PRO Harmonization Meetings Coordination Committee: Bernard Jambon, Patrick Marquis (ERIQA) Paul Kind; Nancy Kline Leidy (ISPOR) Ivan Barofsky, Dennis Revicki (ISOQOL) Margaret Rothman, Nancy Santanello (PhRMA HOC)

With the support of: Laurie Beth Burke (FDA Advisor); Catherine Acquadro (Coordinator); Jean-Paul Gagnon (Moderator)

Contact Persons:

ERIQA: Dr Catherine Acquadro, Mapi Research Institute
ISPOR : Dr Nancy Kline Leidy, MEDTAP
ISOQOL: Dr Dennis Revicki, MEDTAP
PhRMA HOC : Dr Margaret Rothman, Janssen Research Institute