Health-related quality of life assessment in EORTC cancer clinical trials.

6090 Background: Over the last three decades health-related quality of life (HRQOL) has become an important part of the randomised controlled trials (RCTs) conducted by the European Organisation for Research and Treatment of Cancer (EORTC). This review aims to undertake a descriptive database evaluation of all the HRQOL studies conducted in EORTC since 1980. Methods: The EORTC protocol database (n=785) was reviewed, restricting the search to between 1980 and 2011 (n=735). We investigated the number of HRQOL studies conducted in EORTC trials, the RCTs’ status and the use of HRQOL tools since 1980. Results: 157 protocols with HRQOL assessment were identified involving 70,903 patients. 73 studies ended as defined in the protocol; 27 studies closed early due to poor accrual; 17 are at the final analysis of the primary end point stage; 14 studies are still open to recruitment; 11 are closed to patient entry; and 15 new RCTs are pending activation with HRQOL. The majority of phase III (n=135) and phase II/III (n=9) RCTs have HRQOL as secondary endpoint. EORTC also conducted a number of large scale field studies (n=11), where HRQOL was the primary endpoint. During the early period of 1980 to 1989 HRQOL was assessed in 12 EORTC RCTs by using a small number of HRQOL items, but from 1990 to 2000, HRQOL was assessed in 97 RCTs using more comprehensive HRQOL tools. Between 2001 and 2011 the number of RCTs with HRQOL was 48. The EORTC clinical groups with the most RCTs containing HRQOL were Radiation Oncology (n=22), Genito-Urinary (n=20), Gynaecological (n=16), Breast Cancer (n=16), Lung (n=13), Gastrointestinal, (n=13) and Brain (n=10). The EORTC HRQOL tools were used in 90% of the trials, with other validated tools being used when required. Conclusions: Our review of EORTC RCTs has shown how patient perspective has been constantly considered of major importance in oncology during the last three decades. The inclusion of patient perspective in drug development shows that a more comprehensive HRQOL assessment has taken place over time as better instruments have become available. As the positive value of patient perspective grows to clinicians, regulatory bodies and industry, we expect that EORTC will continue its support by including HRQOL endpoints where appropriate.