QUALITY-OF-LIFE ASSESSMENT IN CLINICAL-TRIALS - GUIDELINES AND A CHECKLIST FOR PROTOCOL WRITERS - THE UK MEDICAL-RESEARCH-COUNCIL EXPERIENCE

Many clinical trials groups now routinely consider including Quality o f Life (QoL) assessment in trials. Indeed, several have policies stati ng that QoL should be considered as a potential endpoint in all new tr ials and that if it is not to be evaluated the applicants should justi fy not doing so. However, inclusion of QoL in clinical trials presents a number of difficult organisational issues, and serious problems in compliance have frequently been reported. Thus, in multicentre clinica l trials many of the expected QoL questionnaires fail to be successful ly completed and returned, although a few groups have claimed high suc cess rates. However, it is well. recognised that if questionnaires are missing, there may be bias in the interpretation of trial results, an d the estimates of treatment differences and the overall level of QoL may be inaccurate and misleading. Hence it is important to seek method s of improving compliance, at the level of both the participating inst itution and the patient. We describe a number of methods for addressin g these issues, which we suggest should be considered by all those wri ting clinical trial protocols involving QoL assessment. These are base d upon over a decade of experience with assessing QoL in Medical Resea rch Council (MRC) cancer clinical trials. In particular, we provide a checklist for points that should be covered in protocols. Examples are given from a range of current MRC Cancer Trials Office protocols, whi ch it is proposed might act as templates when writing new protocols. ( C) 1997 Elsevier Science Ltd.