The Lack of Uniformity in Recording Race and Ethnicity in Pharmacological Studies

S Punnialingam, T Mant. 1Guys' and St Thomas' Hospital, London, UK, 2Imperial College, London, UK

Introduction: Studies have shown that there is a race-dependent variability in response to certain drugs such as anti-hypertensive drugs. In drug development, it is important to predict factors that can alter the dose-response relationship. Although data on race and ethnicity has been collected in numerous drug trials using this data can be misleading because of inconsistency of classification. The aims of our study were to identify how members of the pharmaceutical industry perceive race and ethnicity, to analyse how we report this information and whether race/ethnicity influence event reporting in pharmaceutical research.

Methods: Part A: An observational study was conducted over two Phase 1 trial sites: London and Kansas. Allied professionals from both sites were approached and they filled a questionnaire anonymously. The questionnaire included ten open questions in which covered how they would categorise race/ethnicity, how would they report an individual’s race and how would they self-report their own race/ethnicity.

Part B: Twelve Phase 1 studies conducted in 2008-2010 were randomly chosen and comparisons were made between the original self-reported race data with resultant published data. This was done to identify any evidence of bias in collecting data on race.

Part C: A bridging study’s reported adverse events were analysed to assess whether racial differences affect the reporting and rate of adverse events.

Results: Part A: Sixty replies from London and 50 replies from Kansas were received with a response rate of 86% and 63% respectively. There were discrepancies two sites. Only 50-60% were able to allocate people to categories set up by FDA guidelines. Sixty respondents in London were asked to self-report their own race which had resulted in 28 different racial categories.

Part B: Four out of twelve Phase 1 studies which recorded volunteer’s races had potential of misclassification bias.

Part C: All 15 Japanese volunteers complained of some pain after receiving drug i.e. abdominal pain or myalgia whereas only 2 volunteers from Caucasian group complained of pain. Consistently, 30% of all adverse events reported by both populations were related to the drug administered.

Discussion: Our results show individuals classify race differently and self-classification is influenced by the individual’s education, cultural and social background. This can translate into poor or varied documentation of how data on race is recorded and published. There is also the issue of how cultural and social modalities of an individual can affect how they exhibit side effects and this is important particularly in having a varied population in early Phase 1 trials.

We propose a simple questionnaire that should be used globally. This questionnaire should identify the individual’s current environment, their own and their parents’ birthplace with their self-identified phenotype. This will give standardised information on the individual’s environmental, social, geographical background which will contribute to the progress of personalised medicine.