FDA updates Guidance on Race and Ethnicity Data Collection in Clinical Trials
On October 26, 2016, the US Food and Drug Administration issued an update to its Guidance on the collection of Race and Ethnicity Data as part of Clinical Trials. While the Guidance is fairly straightforward, it is important to consider the FDAs reasoning behind it, both with the update and initially.
One of the main reasons that the FDA has taken this route is that in the past most clinical trials consisted of homogeneous populations, largely male and white. This may be a great way to figure out if your drug product is going to work, but in the end, it only tells you how your drug will function in that population. You may get some signals through pharmacokinetics which can give you clues as to how they will behave, but the FDA realizes that nothing beats actual data.
In the Guidance, the FDA notes that there are three main factors that influence how pharmaceutical products behave in different populations. These are intrinsic, such as genetics or metabolic, extrinsic, such as environment and sociological, and finally a combination of the two.
Companies will need to be familiar with this updated Guidance, and understand its implications on your Clinical Trials Program. As therapies get more and more specialized, this brings an understanding of Race and Ethnic differences into the forefront of what companies need to consider for their Clinical Trials, and a good consultant can always help you in being prepared for these eventualities.