Quality of life terminology included in package inserts for US approved medications.

Objectives: To identify and review prescription drugs approved in the US containing quality of life (QoL) terminology within the package inserts (PIs).

Methods: The electronic Physician Desk Reference (PDR) was searched for the terminology 'Quality of Life' or 'QoL' as of December 2000. Summary basis of approvals (SBAs) served as the primary data sources were retrieved. The two categories evaluated within the SBAs were QoL components (year submitted, trials, efficacy, statistics, type of submission) and QoL instruments utilized within clinical studies.

Results: Eighteen medications comprising 20 indications with QoL claims were documented in the PIs. The first approved QoL claim was submitted in 1989 and the most recent was in 1998. Eight (40%) of the drug indications had QoL measures included in two trials. One quarter of the PI listings used QoL measures as primary efficacy endpoints. Many sponsors provided detailed information on the types or categories of QoL data collected.

Conclusion: Many drug development programs incorporate QoL measures into clinical studies however only a few are accepted into the PI. Despite this study finding, the increased interest in assessing the value and full impact of new therapies has led to greater inclusion of all types of patient assessments in clinical trials.