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Sir, We read with interest the article by Bell et al (2006) that reviewed the quality of the methodology in cancer pain clinical trials. It has also been our experience that the methodology employed in these trials has frequently been less than optimal. To further quantify this problem, we undertook a systematic qualitative review that specifically explored the pain assessment methods used in oncological clinical trials (Caraceni et al, 2005) and reached similar conclusions to those of Bell and colleagues. For our review, we examined 68 journal articles published between 1999 and 2002 that had chronic cancer pain as the primary or secondary objective of a controlled clinical trial. Only 57% of these studies reported on the clinical characteristics of the cancer pain, and in 81% pain pathophysiology was not mentioned. More specifically, regarding the use of pain assessment methods, we observed that:  Our review concluded with a number of recommendations that we believe will enable researchers and clinicians to approach this field of study with more consistency and rigor – through an enhanced understanding of how to choose, implement, analyse and report pain measurement methods and data in oncology clinical trials.

Enhancing the quality of clinical trials in cancer pain first requires that pain assessment methods are appropriately understood and used