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FDA Calls for More Participation and Diversity in Clinical Trials

The US Food and Drug Administration (FDA) has released a consumer update encouraging participation as well as diversity within clinical trials.

In order for researchers to develop new ways to treat individuals in need, clinical trials are essential. The US Food and Drug Administration (FDA) has issued a Consumer Update that includes education material on the importance of these trials and also encourages individuals to sign up.

Clinical trials, as defined by the FDA, are “voluntary human research studies designed to answer specific questions about the safety and effectiveness of drugs, vaccines, devices, and other therapies—or to study new ways of using existing treatments.” These trials are vital for the FDA, because the data that they yield will help them reach a decision and that decision can change lives.

However, the unfortunate truth is that not many individuals are signing up to participate in clinical trials. According to the FDA, there are a number of reasons as to why participation is so low. For one, doctors who conduct these trials do not often also see patients and so that avenue to create awareness and solicit participation is not there. In addition, lack of time or insufficient resources to actually get to a site where a trial can be held may also contribute to the lack of participation. For example, if some trials are conducted out of the United States (and many of them are), those living in the United States who don’t have a way to reach the trial site will not enroll in the trial.

Perhaps the biggest reason of all, though, is that many patients are afraid. Because of the effects of studies that have been conducted in the past—such as the disturbing Tuskegee Study—individuals may be more reluctant to volunteer. The Tuskegee Study, although initially estimated to last for just 6 months, actually continued for 40 years, without the patients’ informed consent. Furthermore, those running the trial reportedly prevented enlisted subjects from receiving needed treatment, and they were not even provided with the choice to opt-out. What many volunteers may not know is that it is because of this trial that significant changes have been made to how clinical trials are conducted.

In order to ensure that trials are conducted the “right” way, or “in order to protect the rights, safety, and welfare of patients” enlisted, there are ethics committees—known as institutional review boards, or IRBs—that are involved in the process. These individuals, who are not associated with those running the trial, are responsible for looking over research plans prior to the start of the study and following up while the research is being conducted.

By making individuals more aware of these measures to protect their rights, perhaps the stigma associated with clinical trials can be defeated. That doesn’t mean that there aren’t a number of possible risks that come with enrolling in clinical trials, but at least individuals will be given this information up front. Participants will be made aware of known risks during the consent process of enrollment. There is also a chance that participants will be put in a group that receives a placebo, therefore not receiving the desired therapy in the study at all.

As with anything new, there may be additional risks that will not be known until after the trial has started, but, it is important to remember that although there are risks, there are potential benefits as well. Although there are “no guarantees” when it comes to a “promising therapy”—it may work; it may not—participants are not only advancing scientific knowledge, but they have the opportunity to help others. Their participation can further the research and development of new medical products, drugs, or vaccines that can potentially save a number of lives.

In addition to addressing the issue of decreased participation, the FDA also stressed the fact that diversity is needed in these trials in order to offer the “full picture.” This means that the group of participants should include individuals of all ages, races, ethnicities, as well as genders—unless the products are meant for a specific population, such as gynecological products for women or potential prostate cancer treatment for men.

If the trial is on a potential medical product, the participants should represent “the types of patients who are likely to use the medical product” if it were to receive approval in the future. Also, due to the fact that some individuals are at higher risk than others when it comes to different diseases, patients who have an increased likelihood of being treated for those conditions should be included in that trial. Lastly, the FDA noted that response to medical products is known to differ among diverse groups. Therefore, “information on those differences can then be included in the product labeling to help doctors and patients make treatment decisions.”

By working collaboratively with a number of stakeholders—medical product manufacturers and healthcare professionals among them—the FDA is channeling their efforts into encouraging diversity within clinical trials. They have also provided the public with resources that work to both encourage individuals to enroll in these trials and inform them on “what they need to know.”

For those interested in enrolling in a clinical trial, the FDA encourages you to contact your healthcare provider. The National Institutes of Health also keeps a list of trials that are ongoing, so you can find a trial that works best for you.