Within any clinical trial, the use of scientific burdens of proof is a very important theme. Through elements like blind- and double-blind studies, placebos, control groups and others, the goal is to arrive at scientifically and statistically significant results that can be proven using real, tangible evidence.
At AGA Clinical Trials, all of our medical research studies are carried out using proper scientific method and evidence-gathering formats. One theme that’s vital for ensuring research on a given drug is done properly and will allow that drug to reach the market safely and provide positive results to patients? Diversity in the study, which is important not only from a fairness and representation standpoint – it’s also vital to ensuring accurate data across groups of people who might respond differently to a given drug or treatment. Here are a few areas of diversity that we work hard to promote during our medical trials.
Ethnic or Racial Groups
Unfortunately, ethnic and racial minorities have historically been underrepresented in clinical studies across the United States. While these groups make up nearly 40 percent of the American population, their presence in clinical studies tends to range between 10 and 20 percent for most groups.
This is something trial organizers across the country have been working hard to correct over recent years. Without proper representation from these groups, several conditions such as cancer, heart disease, diabetes and others may go badly under-studied for them – and treatment factors may differ somewhat widely for these conditions between various racial or ethnic groups. This means that without enough participants from these groups, any treatments or procedures developed for these conditions may not necessarily be effective for the underrepresented groups, and could lead to side effects or other concerns.
Another area where medications and other treatments affect different groups in widely varying ways is within the realm of age. Many treatments that are perfectly safe for healthy adults, for instance, are not safe at all for young children or older adults with compromised immune systems. There are numerous other potential differences in age here, and gender may also play a role.
Once again, you can see why it’s vital to test a variety of age ranges for a given drug or treatment if applicable. This means children or seniors are often included in studies, sometimes during the later stages of testing.
Finally, you may have heard about healthy volunteer participation in clinical trials – this is actually another form of introducing diversity into the study. By first testing many products on healthy volunteers, trial organizers can get an idea of basic effectiveness or side effects before studying it on less healthy people. This kind of control group is exactly why diversity is important in any clinical trial.
For more on how we promote diversity in our research studies, or to learn more about any of our trials or healthy volunteer programs, speak to the staff at AGA Clinical Trials today.