Standardization of pain measurements in clinical trials

Standardization of the measurement of pain in clinical trials will reduce variability, thus improving the quality of the data and reducing the number of patients needed to conduct pain trials. Standardization applies to the physical and psychosocial environment surrounding the patient, and there are many elements within this environment that can be effectively controlled. For example, the appearance of the examination room can be selected for neutrality and influences from visitors and staff can be minimized. Training is an important aspect of the standardization process and should be provided to all study staff. Staff training should first provide orientation on the protocol objectives and procedures and then a thorough discussion of the pain measures being used and how assessments will be conducted. Furthermore, as the patient is ultimately responsible for assessing his or her level of pain, it is important to train the patient to make reliable and accurate assessments of pain.