Myths and Facts About Joining Clinical Trials

Every single one of us has taken a drug before, whether it is Advil, Tylenol, Mucinex, or a prescription. But have you ever thought how we determined their dosage, who can take them and their overall safety profile? These medications underwent years of scientific studies to discover their healing properties, side effects, and any other drug interactions. These studies are called clinical trials.

When we think about clinical trials, we often think of top-of-the-line treatments for difficult to treat diseases. While many clinical trials are focused on the earlier stages of developments for treatments against cancers, Alzheimer’s, and diabetes, for example, clinical trials look at the drug’s safety and effectiveness profile for all medications available to us. And we learn a lot from these studies! Not only do these studies show us how these drugs work, but it helps understand how new drugs can be engineered to help find even more cures for todays and future patients.

Although clinical trials are essential to us all, there are many myths and facts about what clinical trials are, how to participate in them, and what the costs and benefits are. Many clinical trials often close prematurely due to low levels of accrual. Unfortunately, it is estimated that around 50% of United State residents report knowing nothing about clinical trials. Moreover, less than 10% of United States residents have reported to even been invited to participate in clinical trials; and of that population, only roughly half decide to participate. It is important to debunk the myths of clinical trials so that we can not only increase participation in ground-breaking science but understand how important availability and accessibility to clinical trials is to our health and livelihood.

 

MYTH: You must have a terminal illness to participate in clinical trials

FACT: Many different types of people can participate in clinical trials. Some studies include healthy volunteers, while other studies include patient volunteers; some studies include both. Eligibility criteria determine who can participate in a clinical trial. These criteria ensures that new approaches are tested on a similar group of people. These criteria are not used to reject potential participants personally; instead, the criteria are used to identify appropriate participants and keep them safe.

 

MYTH: You can only join a clinical trial if all other options have been exhausted

FACT: Clinical trials are available throughout disease processes. Additionally, many clinical trials look at preventative methods to stop disease from even occurring in the first place. Clinical trials don’t just look at new drugs. They also look at different clinical interventions, new treatment or surgical techniques, different diagnostic tools, or new approaches to improving quality of life.

 

MYTH: Clinical trials are dangerous because they are using untested drugs in humans

FACT: Before any potential treatment is given to humans, they undergo extensive preclinical testing in cells and laboratory animals. It is also important to note that the institutional review board (IRB) reviews each and every study to ensure that the trial is safe and ethical for participants. The IRB is not just used at the beginning of a trial; instead, the IRB constantly reviews incoming data. If there is a safety concern, the study is stopped and examined to see if any changes must be made or if the study should stop. Furthermore, depending on the phase of the study, the drug may have already gone through additional testing in humans as well. Each phase has a different purpose and helps researchers answer different questions. Here is a brief summary of the clinical trial phases:

Phase I: A treatment is tested in a small group of people (20-80) for the first time. The purpose is to learn about the safety profile and identify side effects.

Phase II: The treatment is given to a larger group of people (100-300) to determine effectiveness and further examine its safety.

Phase III: The treatment is given to a large group of people (1000-3000) to confirm its effectiveness, continue monitoring side effects, compare it to the standard of care or similar treatments, and to continue its safety profiling.

Phase IV: After the treatment is approved by the FDA and made available to the public, the treatment is continued to be monitored to track its safety in the general population to further understand the treatment’s benefits and optimal use.

 

MYTH: Diversity in clinical trials is unimportant

FACT: Lack of representation compromises the generalizability of clinical trial findings to the greater population. Representation by self-identified race and ethnicity is important, as some genetic factors that may result in differences in drug responses may be more common in certain ancestral populations. However, some results, although seemingly due to race or ethnicity, may not be based on genetic factors; instead, they may be based on differences in lived experiences that result in differences to drug interactions. For example, it is well-known that lived experiences of racism, lower socioeconomic status, and lower education levels are associated with levels in blood pressure and increased cardiovascular risk. It is important to note that while patients with these lived experiences may in fact share self-identified race or ethnicity, it is not inherently due to their genetic factors but instead their non-genetic factors. Furthermore, lack of diversity may hinder innovation. Exploring the diversity in treatment effects are necessary to understand the variation in safety and effectiveness in different racial, ethnic, gender, and age groups. These results can identify new biological process that may, in turn, lead to new discoveries in all populations.

 

MYTH: Only adults can participate in clinical trials

FACT: People from all ages can participate in clinical trials. Although specific studies may look at certain age ranges, it is important for people of all ages to join clinical trials because responses to treatment may vary with age.

 

MYTH: It is expensive to participate in a clinical trial

FACT: Clinical trials vary in cost for medical care, but generally all research-related costs are covered by the clinical trial. Many trials are covered by the sponsor of the study, but other trails use a patient’s insurance plan, if available, or require out-of-pocket expenses. Sometimes, trials require participants to travel, which mean other costs such as travel, lodging, and meals may occur. Some trials cover these extra costs, so it is important to ask the research team what financial support is offered to participants. If you are uninsured, you can still participate in clinical trials. Some studies take place in low-income populations. If you receive care at these sites, you may still be able to take part of these studies at little to no cost. There also several organizations that help supplement funds for participants regardless of income or insurance status. It is important to ask the study coordinator which costs are covered, and which ones are not.

 

MYTH: Once I commit to a clinical trial, I cannot leave the trial

FACT: Participation in clinical trials are voluntary, and you can leave a trial at any time without penalty, even after signing a consent form. All clinical trials must have an informed consent process where participants learn the key facts about the trial to help them decide whether to participate. This guarantees that patient welfare and autonomy are prioritized. It is also important to note that withdrawing from one study does not prevent you from participating in future studies.

 

MYTH: You’ll receive a placebo (“sugar pill”) instead of a new treatment

FACT: Placebos are typically rare in treatment clinical trials. In most cases, new treatments are compared with the standard of care, meaning that if you are not to receive the new drug, your treatment plan would be the same as if you did not participate. This is important because it means that there are no compromises to your care. If placebos are used, you will be told ahead of time during the consent processes. Placebos may be used, but they are used when there is no standard treatment or in other types of trials like prevention trials. Again, your participation in a clinical trial will not compromise the care you will receive.

 

MYTH: Clinical trials are only beneficial to researchers

FACT: Although clinical trials can lead to scientific discovery, clinical research serves many benefits to patients. Joining a clinical trial gives you access to new drug or therapy options. Working with researchers also allows to be part of new prevention, diagnostic, or treatment methods that help you learn more about your condition. Additionally, joining a trial may connect you with others experiences similar health conditions. If you are a healthy participant, you may benefit by receiving additional health care that you otherwise would have not receive. Also, some participants join due to their own altruism and feel privileged to be part of scientific innovation.

 

MYTH: Once the trial ends, I will no longer be able to receive the new treatment even if it is working

FACT: Many trials will continue patients on a trial as long as the patient is benefiting from and tolerating the treatment. This is outline in the informed consent process. Each trial has an institutional review board (IRB) that is in place to protect the rights and welfare of patients. The IRB typically urges drug companies that provide the drug for a trial to continue the drug’s availability if the drug is benefiting the patient.

 

How to join a clinical trial

New clinical trials are popping up every day. Talk to your health care provider to see if you are eligible for a clinical trial. You could also search for available trials by going to clinicaltrials.gov. There you can search for conditions/diseases, treatment options, location, study status (recruiting or current studies), and other eligibility criteria.