Barriers to Clinical Trials
If you have been diagnosed with lupus, you are likely concerned about treatment options. Currently, a limited number of drugs are used to treat lupus. However, doctors have found at least 20 more chemicals they believe may treat the disease.1
The problem is, creating and testing new treatments takes time and money. Plus, there are many barriers that can hold up the process.
Doctors who study human diseases must get approval from their organization’s institutional review board and the U.S. Food and Drug Administration to conduct a clinical trial. They also need money for staff, supplies, and tools. This money may come from donors, the government, companies, a university, or a hospital. Then, they must find patients willing to try their new drug, surgery, or treatment plan.
People who want to help advance medicine are a vital part of clinical research. Many volunteers are needed to participate in clinical trials. Each trial has special requirements to join. Depending on the trial, the doctors may be looking for people of a certain age, gender, weight, who are treated at a certain hospital, or who have taken particular drugs.
Barriers for people with lupus
People may know research is important to improve medical care, but they may not know they can be involved. For patients, the topic may not have come up at health care appointments. Even if some are aware of clinical trials, they may not know how to ask their doctor about the next steps.
Personal beliefs can stop some people from joining clinical trials. Other people may not realize or value the benefits of such studies. Learning of potential risks and side effects may scare off some. A few people may worry about what others will think of them.2
Not everyone who decides to try a clinical trial completes the process. Some find it hard to follow the rules that come with a trial. A study published in 2020 found that logistics such as transportation and time were the biggest barriers to people with lupus sticking with a clinical trial. Common barriers included the need to arrange childcare, complete lengthy paperwork, take time off from work, and travel.2
Even if people agree to a trial, there may not be enough volunteers to represent the population under study. Lupus, for example, affects more African Americans and Latinos and is often more severe in these groups. However, not enough people of color are recruited to join lupus trials. To get the most useful results from lupus clinical trials, ethnically diverse volunteers are needed.1,2,3
Barriers for doctors
A 2019 study on lupus clinical trials shows that knowledge, logistics, and personal views are major barriers for doctors too.3 Some doctors work in private practices where research is not conducted. Others work in large hospitals and universities where lots of trials take place.
Doctors may not be aware of all the clinical trials available for lupus. ClinicalTrials.gov, a government website, lists over 300 clinical trials related to lupus.4 This can make it time-consuming for a doctor to research which trials are right for each patient.
Some doctors may not have enough time to promote clinical trials. They would have to first spend hours learning about the different trials. Then, they would need to connect with the people leading the trials to get referral information. Finally, doctors would have to talk to their patients about the clinical trial.3
What doctors believe about clinical trials can be a hindrance as well. They may feel that the risks of clinical trials are greater than the benefits to patients. They also may not share information about clinical trials if they think it will hurt their bond with their patients.3
Benefits of clinical trials for lupus
Despite these barriers, many people with lupus and their doctors choose to play a part in clinical trials. Many patients value the extra care they get and access to new, promising therapies. Patients and doctors both want to make a difference and contribute to better treatments.1,2
Joining a clinical trial may be a great way for you to improve what we know about lupus. If clinical trials interest you, talk to your doctor about finding one that is right for you.
Does your employer provide workplace accommodations due to your lupus?