Clinical trials to real life: the relevance of quality of life

Over the past decade, the assessment of quality of life (QOL) has become an almost mandatory requirement in clinical trials for cancer therapy. However, many clinicians still remain sceptical about the value of QOL and few routinely use the instruments outside a trial setting. QOL assessment has been hampered due to numerous factors including the lack of a clear definition of QOL, an inability to select tools that are valid and reliable, and misunderstandings about appropriate methodology and statistical tests with which to analyse the data. Failure to employ QOL measures in the clinic can lead to undiagnosed and untreated psychiatric morbidity associated with cancer, which can adversely affect patients‘ QOL, adherence to therapy, and future choice of therapy. Benefits of regular and systematic QOL assessment include more appropriate decision-making about treatments and optimal timing of supportive interventions. Methods for the proper assessment of QOL and for handling missing data in clinical trials and routine clinical practice, will be discussed in this paper. Automated data collection systems may considerably reduce the effort needed to collect QOL that may encourage clinicians to introduce QOL assessment in their clinics.