Rose Holub - Nov 15, 2018

Debunk Clinical Trial Comics with Your Ratings!

With each day that passes there is no denying that the art of reading the newspaper has dwindled. “In 1960, there were 1,763 total daily newspapers (morning and evening) with a total circulation of 58,882,000; in 2014, there were 1,331 with a total circulation of 40,420,000. Meanwhile, average daily newspaper readers are now in their mid-50s and getting older. And reading the newspaper is not a habit with younger generations, who prefer to get their news online (ironically, often at newspaper websites) or via social media like Facebook or Twitter.” But what hasn’t dwindled is the readers desire to get their daily fill of laughter by reading comic strips- “The Funnies”.

Comic strips have been a part of our culture for decades and continue to be an integral part of life. Why? It could be said it is because in so many ways comic strips reflect our society and culture, as evidenced by the re-establishment of characters to better reflect today’s sensibilities and America’s diverse population. Or maybe it’s because at the end of the day we are all just looking for a good laugh. Either way, these little drawings with characters and speech balloons stick with us.

Unfortunately, there are some comic strips out there that we might not want to stick with us. Some comics are derogatory, offensive, or in general create a mockery of whatever the comic is depicting. I’ve found several comics that support common, negative, stereotypical myths of participating in clinical trials.

 Myth:_Clinical_trials_include_painful_parts

Myth #1: Clinical trials may include painful or unpleasant parts.

Sometimes, this is all potential study volunteer can imagine participating in a clinical trial is like: pain. It is true, like all medical interventions, clinical trials have potential benefits and risks, such as side effects or pain, but each clinical trial is unique. Some clinical trials may involve giving a blood sample, just like you would when your own doctor asks that you have some blood work done to ensure you are healthy. Other clinical trials may simply require a standard set of vital signs be taken: blood pressure, body temperature, and heart rate, all barely invasive procedures that cause no pain. No matter what procedures occur in the clinical trial, you always have the opportunity to talk to the doctor and discuss expectations and any questions or concerns you might have.

 Myth:_Clinical_trials_are_dangerous_because_they_use_experimental_medicines

Myth #2: Clinical trials are dangerous because they use experimental practices and medicines.

The very nature of clinical research is research. Research is how we find answers to questions that previously did not have an answer. As a result, it is impossible to conduct any kind of research without some level of risk because we simply do not know what we do not know. There is always the risk of experiencing a negative (or adverse) event to the medication being researched.

I’d like to try to take the “scary” out of the word research and show you that throughout life we are constantly researching, it’s not something that happens just in laboratories. For example, as a child, we learn through the research process. It’s interesting to think about it from this perspective, but it is, in fact, a way in which we learn. When I was about 6 years old, I had this silver Goofy fork that I just loved. I knew that its intended purpose was to help me eat food, but what else could this awesome utensil do? Much like clinical research, scientists create new medications and then try to determine how these medications could best be used. Now, I didn’t know of any risk associated with my Goofy fork, I just knew I could eat with it. Through research, I also found that it made a great tool to keep a beat alive by tapping it on the table (no harm with that except maybe the annoying noises I made that tortured those around me). Then one day when I was sitting at the table with my Goofy fork, I looked down at the wall and saw an electrical outlet. It had two, long, narrow slots that looked like something my Goofy fork would fit right into, and who knows, maybe it was the key to unlock something special! I think you can already guess where this is going. Yes, I shoved my Goofy fork into the electrical outlet, and Ladies and Gentlemen, did I learn!

While I had not previously known there to be any adverse events associated with my Goofy fork, I did now. The same applies to clinical research. Risk and potential adverse events are part of the clinical research process; it’s how we learn and how we improve. I learned that shoving metal objects into an electrical outlet is going to temporarily hurt and is not what a fork is used for. In a clinical trial, an adverse event provides researchers with tons of critical data that allows them to further modify the medication to make it better!

It’s also important for you to know that while there is always risk involved, the risk is assessed by people (including the doctor and study staff) that have only your best interests in mind. For example, all clinical trials are reviewed before they start by an institutional review board (IRB), a committee made up of doctors, scientists and community members who have the responsibility to protect clinical trial participants. The purpose of IRB review is to ensure both before and during the clinical trial that appropriate steps are taken to protect your rights and safety. During the clinical trial, researchers frequently and rigorously assess and monitor the study volunteer’s safety status. In addition, the IRB also ensures that the benefits and risks are carefully weighed and that the clinical trial is reviewed for unnecessary harm or discomfort before it starts.

 Myth:_In_Clinical_trials_humans_are_guinea_pigs

Myth #3: When you’re in a clinical trial you’re just a human guinea pig.

You may be hesitant to participate in a clinical trial because you are concerned that you will be treated as a set of symptoms rather than as a human being with a medical need. Or, you might worry that you will be given completely untested medication without fully understanding the clinical trial or providing consent. However, the truth is, strict guidelines are in place to ensure that you and all other clinical trial volunteers are treated fairly and ethically. Before any medication being researched can be given to a study volunteer, scientists must complete a rigorous screening and preclinical testing process, which can take up to six years to complete. Additionally, as previously mentioned, the clinical trial is reviewed by the IRB, ensuring it is ethical and not placing the rights and welfare of patients in harm’s way. Finally, every clinical trial has a thorough informed consent process, which provides you with all the necessary information to ensure you are fully informed of all aspects of the clinical trial as it pertains to you. Even after signing informed consent, you always have the right to end your participation at any time for any reason!

Myth:_In_clinical_trials_patients_might_get_placebo

Myth #4: If I join a clinical trial, I might get a "sugar pill" or placebo instead of the real medication.

It is true that in clinical trials, there is often a placebo component. A placebo is a product that looks exactly like the medication being researched but does not cause harm or good. The decision about whether to use a placebo in a clinical trial is based on how serious the illness is, whether an existing, FDA approved treatment is available and other considerations that ensure a high standard of ethics. For example, if you decide to participate in a clinical trial and have a serious or life-threatening disease, the best available treatment (called “standard of care”) will be used instead of a placebo.

However, there are clinical trials where study volunteers may get just the placebo. Even though the placebo may have no direct impact on you, the data gathered from your participation is critical in supporting the medication being researched. Even by receiving a placebo, you are greatly contributing to the advancement of medicine.

The library of congress has a section dedicated to comics; yes, you read that right. Megan Halsband, a librarian who also curates the library of congress’ comic collection states: “people who are reading comics want to see characters and a story that reflect their experience.” If you’ve participated in a clinical trial you know that these comics are not accurate. Unfortunately, for those who have never participated in a clinical trial, these images and concepts are the ones that stick with them. Rating your clinical trial experience allows others to learn more about the truths of participating in clinical trials. Rate your experience today, debunk these comics, and pave the way for new comics to reflect the true clinical trial experience!

Written by Rose Holub

Rose Holub is the Regulatory Compliance Manager at Circuit Clinical. When she is not blogging, Rose oversees all regulatory and compliance aspects of the company as related to clinical research. After graduating from Arizona State University, where she earned her master’s degree in Clinical Research Management, her career flourished as she created the compliance department at Circuit. In her free time, she enjoys putting together 1,000-piece puzzles, spending time with friends and family, and experiencing new craft beers and cider.