A new study reports on how patients’ ethnicities can affect their response to certain pharmaceuticals, which can have an important effect on the results and success of clinical trials.
Patients of different ethnicity have different pharmacokinetics and pharmacodynamics parameters, which alter the way drugs are distributed and used throughout the body.
To manage these differences, the FDA issued International Conference on Harmonization E5 guidance that gives recommendations for appropriately regulating clinical trials that consider a range of ethnicity. Largely, the recommendations emphasize that any investigated drug should be classified as sensitive or insensitive to ethnic factors to accordingly design and interpret trials.
However, these guidelines can be particularly difficult to follow when dealing with rare lung diseases such as IPF that remain somewhat poorly understood or defined. “There is considerable variability in diagnosis and management of rare lung diseases,” stated the article. “This may translate into difficulties in designing appropriate study protocols and standardizing all relevant elements of the study, including well-defined diagnostic, inclusion, and exclusion criteria, and suitable endpoints. This variability also poses major challenges to the study?s execution.”