Abstract

Early-phase clinical trials regarding the analgesic effects of a novel study drug necessitate the induction of pain in healthy volunteers to evaluate the drug. The Centre for Human Drug Research (CHDR) has developed PainCart, a comprehensive battery of tests to assess the efficacy of analgesic compounds by administering a wide variety of pain stimuli including thermal, electrical, chemical and mechanical pain.

As this test battery is used in clinical trials that may later be submitted to the FDA, the results of PainCart tests need to be converted into SDTM and ADaM datasets. However, due to the distinct nature of the pain stimuli, there are no known SDTM domains to store this information. Furthermore, the existing therapeutic area user guides (TAUG) regarding pain are related to patients suffering from chronic pain, which is not relevant for these studies, where pain is induced in healthy volunteers.

To overcome this challenge, we created a custom SDTM domain, called XP. This presentation highlights the process and challenges involved in creating a custom PainCart SDTM domain, and shows the conversion from SDTM XP to ADaM XP.