I. Overall Objectives
The main objectives of the PRO Harmonization Program are:
- 1. to clarify areas of concern or confusion about PRO evaluation;
- 2. to explain the added value of PRO outcomes among all key players, i.e. academics, regulators, industry researchers, and prescribers;
- 3. to open and maintain communication between key players; and
- 4. to disseminate meeting outcomes, i.e. to publish papers, to participate in international conferences
It was the consensus of the group that the Program should succinctly address specific issues or concerns, rather than present a didactic review of the PRO field.
II. Specific Meeting-Related Objectives
1. March 31, 2000: "Comparison of Health-related Quality of Life and Regulatory Initiatives in Europe and in the USA -- selection of problematic issues and possible solutions"
- 1. to highlight problematic topics/issues;
- 2. to harmonize recommendations/suggestions (if any) proposed by each organization in their document and gathered in the comparison document;
- 3. to discuss about solutions when no recommendations have been suggested;
- 4. to propose future steps/collaboration to achieve consensus on problematic issues/topics.
2. September 14, 2000: "The Added-Value of HRQL Outcomes: Preliminary Conclusions"
Objectives: to clarify areas of concern or confusion about HRQL evaluation: 4 issues were identified
- 1. Conceptual Issues
- 2. The Issue of Added Value – Specific Situations in Which HRQL is Useful
- 3. Methodological Challenges in HRQL research
- 4. Interest/Demand for HRQL Information
3. February 16th, 2001: “Important Issues in Patient Reported Outcomes Research”
Objectives: to answer FDA's concerns. Four key issues were addressed.
- 1. Conceptual and Definitional Issues
- 2. The Value of Patient Reported Outcomes
- 3. Methodological considerations in obtaining Patient Reported Outcomes in clinical trials
- 4. Interest in and Demand for Patient Reported Outcomes
4. September 21st, 2001: “Important Issues in Patient Reported Outcomes Research: Continued Discussion”
Meeting postponed in March 1st 2002
Objectives: to answer FDA's concerns. 4 issues/concerns have been identified.
- 1. Instrument development: what are the standards?
- 2. Instrument selection: demonstrating hypothesis, relationships to measurement
- 3. Statistical Issues: focus on handling missing data
- 4. Interpretation: interpreting changes that are not consistent between outcomes