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

• European Regulatory Issues on Quality of Life Assessment ( ERIQA ) Group
• International Society for Quality of Life Research ( ISOQOL ),
• International Society for Pharmacoeconomics and Outcomes Research ( ISPOR ),
• Health Outcomes Committee of PhRMA ( PhRMA HOC )
  
  These documents provided suggestions/recommendations/opinions on important topics and issues. At the initiative of PhRMA HOC, and Mapi Research Institute , a comparison of the four documents was undertaken. The idea was to compare all recommendations and explore the differences, and points of controversy. A first meeting, called HRQL Harmonization meeting, was scheduled in March 2000, and gathered representatives from the four organizations above mentioned, and observers from the FDA. One of the conclusion of this meeting was to follow up on this initiative, and set up other Harmonization meetings , under the coordination of a Committee gathering representatives from each organization, and the advise of Laurie Burke (CDER, DDMAC, FDA). At the occasion of the second meeting, (09/2000), the scope was broadened to the notion of Patient-Reported Outcomes (PROs).

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