FDA calls for more patient enrollmentsJanuary 11, 2017
The U.S. Food and Drug Administration (FDA) has noticed that lately for certain reason, there are fewer number of people willing to participate in clinical trials for different medications. Therefore, it has decided to encourage patients to take a part in helping researching companies to develop new drugs.
Clinical trials are voluntary studies on humans that test the safety and effectiveness of drugs and therapies, or to check out new ways to treat certain drugs approved for different problems
Even though the FDA doesn’t conduct clinical trials itself, it does rely on data from such trials to decide if the medical products are safe and effective, and should they be cleared for public use.
Generally, few people sign up for participation in trials, and many of them are not U.S. residents. Also, people older than 75 are also hard to find to sign up. US FDA points out that certain racial and ethnic groups are also not represented well in such trials. This all is the reason for the U.S. food and drug watchdog to encourage more people to take a part, especially of different ages, races, genders, and ethnic groups.
Overall, few people actually sign up for and participate in trials, and those who do participate don’t always represent the U.S. population. Participation is especially low for certain populations, including adults age 75 or older and people from certain racial and ethnic groups. That’s why the FDA is encouraging more patients to participate in clinical trials, especially people of different ages, races, ethnic groups, and genders.
The FDA wants to have a full picture of the risk or benefit of a medical product, patients enrolled in a trial should be representative of the types of patients who are likely to use the medical product if it is approved or cleared by the FDA.
Certain populations can be more at risk for certain diseases—such as diabetes and heart disease—than others. That’s why it’s imporant that researchers should test medical products in all groups of people to help ensure medical products are safe and effective in everyone who will use them. That’s why diversity in clinical trials is essential.
Risks and benefits of clinical trials?
Sometimes patients enroll in a clinical trial to get early access to what they believe is a promising therapy. However, there are no guarantees that the therapy will work. They could also be assigned to a group that receives another approved treatment or placebo, for comparison.
But clinical trials also can carry serious risks—an important fact to consider. Participants learn about known risks during before the process, but sometimes risks are not known until clinical trials are under way or completed.
What are some related FDA regulations?
FDA regulations require product developers who submit applications for medical products to analyze clinical trial data by sex, age, and race. The FDA expects medical product research to reflect the relevant science.
FDA encourages diversity
The FDA is working with a variety of stakeholders, including federal partners, medical product manufacturers, medical professionals, and health advocates.
The FDA’s Office of Women’s Health, along with the National Institutes of Health (NIH) Office for Research on Women’s Health, launched an initiative to raise awareness among women and share best practices for clinical trials.
The FDA’s Office of Minority Health also has tools to encourage people and their health care providers to learn about trials, including public service announcements (PSAs).
Many people volunteer for clinical trials to help others. So, although you may not directly benefit during a clinical trial, the information collected can add to scientific knowledge and help with future research and product development, considering all the risks.