We all know the importance of clinical trials in general. Without them, there would be no new treatment options available, or at least no new safe and effective treatment options. Who knows what could be readily available to the public without the extensive research that goes into putting a new drug onto the market!
The same could be said about diversity in clinical trials. Medications can affect people of different ethnicity, race, gender, age or lifestyle in very different ways. Without representation from all groups, there is no way to ensure that the data gathered is totally accurate. Historically minorities have been underrepresented in clinical trials, but we’re striving to change that![1]
Ethnic/Racial Groups
Ethnic and racial groups make up about 40% of the American population, but their representation in clinical trials typically falls somewhere between 10-20%. Contributing factors of conditions such as heart disease, cancer and diabetes can vary between different ethnic and racial groups. Without accurate representation, there is no way to know if a medication is effective in all groups or if any side effects pop up within one group or another.[2]
Age
The way medications affect different age groups is even more apparent than ethnic/racial groups. Something that is safe for a fully grown adult, may not be safe for a developing child or an elderly person. The way the body metabolizes is different; our bodies are at different levels of development, so it is not feasible to approve something for age groups the drug has not been tested on. The inclusion of children and elderly, in the later phases of testing, of course, is a must for the most accurate data.[3]
Lifestyle
The inclusion of unhealthy and healthy volunteers in a study is a vital step in the drug approval process. For instance, if you are a testing flu vaccine, you would first want to test on healthy volunteers. This way, if there were any negative side effects, or if the drug is ineffective, it would be easier to see. Once it is proven safe and effective for healthy volunteers, you would then go on to test in unhealthy volunteers, such as those with heart disease, cancer or diabetes. If negative side effects show up here, it could be contributed to the underlying disease. We would then know the drug is not safe for those with that condition.[4]
Having diversity in clinical trials means having representation from all ethnic/racial backgrounds, age groups, genders, and lifestyles. Now that you know how important it is, it’s time to represent! Get out there and contribute to research. Click here to search for enrolling studies near you!
[1] https://www.lilly.com/who-we-are/diversity-and-inclusion/diversity-in-clinical-trials
[2] https://www.scientificamerican.com/article/clinical-trials-have-far-too-little-racial-and-ethnic-diversity/
[3] http://www.appliedclinicaltrialsonline.com/importance-age-diversity-clinical-trials
[4] https://clinicalcenter.nih.gov/recruit/volunteers.html
