You’re Not a Guinea Pig: The Importance of Clinical Research

• Though negative clinical research trials like the Tuskegee Syphilis study have gained prominence over the years, a former clinical research nurse shares the value of research and how to relay that to patients. 
• Clinical trials advance medicine, nursing, and healthcare. Without them, we would have never discovered some of the novel targeted medications for cancer, asthma, and diabetes. 
• Only through hard work, transparent communication, diligent instruction, and an empathetic, compassionate attitude can trust be built in the idea of participating in clinical trials. 

 “I don’t want to be a guinea pig.” This statement is often heard in clinical research or the clinical trials setting. In fact, I heard this several times throughout my five years as a clinical research nurse. This sentiment, echoed sometimes as a simple phrase and other times as an exclamatory negative, often comes from a state of misunderstanding and fear. 

To address these concerns, there are certain methods and approaches a clinical research professional can use to encourage the individual to thoroughly consider, and possibly enroll, in a clinical trial. 

The History of Clinical Research

Clinical research has a long and storied history. However, for many outside the fields of research, medicine, or nursing, their understanding may be based solely on the most notorious events, such as the research conducted in Nazi Germany and later examined in the Nuremberg trials. But there are other stories. Some are equally as terrible, such as the Tuskegee syphilis study or the use of Henrietta Lacks’ cells after her death without her family’s consent. 

However, additional examples showcase the true intent of clinical research. 

These shining stars and the individuals working in clinical research are celebrated each year on May 20, which is formally known as Clinical Trials Day. This is done in remembrance of the first controlled clinical trial by James Lind in 1747.

During this “trial,” he realized that scurvy, often present in sailors, was caused by a vitamin C deficiency and that supplementing this key nutrient could prevent this debilitating disease. However, the earliest clinical trial, according to the Orlando Clinical Research Center, was documented in the biblical book of Daniel. In this account, Daniel and his three fellow captive Israelites opted to continue their native diet of vegetables when offered the kingdom’s more animal-rich diet. Their “trial” was conducted over 10 days, and, in the end, revealed that they “looked healthier and better nourished than any of the young men who ate the royal food,” according to Bible Gateway.

There are so many other stories about great developments in medicine because of clinical trials. Clearly, there is importance here. The events mentioned, and the myriad that weren’t, make for fantastic reading; however, our knowledge should not stop there. While many individuals in healthcare may never take part in clinical research, either as a participant or as a research professional, a high level of awareness is critical. 

My Experience as a Clinical Research Nurse

Having spent five years as a clinical research nurse in adult oncology, I usually saw patients and families at one of the worst moments of their lives. While there were studies looking specifically at preventative interventions (for instance, breast MRI versus a 3-D mammogram for early cancer detection), most trials that I worked on were specifically for cancer-related treatments. At that point, individuals needed compassion, empathy, and a gentle hand to guide them.

As soon as the words “clinical trial” were mentioned, fear frequently became the top-most emotion. At that moment, it was most important to remember that the people in front of you were just that — people, not research subjects.

Clinical trials, as noted by the National Insitute on Aging, are used to develop and determine the safety and efficacy of new medical, surgical, or behavioral intervention in people. From that definition, it is easy to see why we need clinical trials. However, we need participants to gain the necessary data from those trials. The National Institute of Health has acknowledged several approaches that can be used when speaking with potential participants. They focus on being caring yet informative: 

• First, consent forms and informed consent discussions should be done using standard verbiage in the patient’s native language. 
• Secondly, the potential participant and their family or caregivers should be empowered to participate in the discussion and not feel coerced into any specific decision. The research professional should also acknowledge the trauma and emotional turmoil that the participant and family are likely feeling.

Now, for the more logistical considerations:

• Medical jargon should be avoided.  
• It can be helpful to provide frequent summaries and assess the patient and family’s understanding by reviewing the material in a question-and-answer format.  
• Full disclosure of risks and benefits, with the caveat that some risks may not yet be known, and no difference in the ability to pursue legal advice should something happen can help assuage patient fears also.  
• Finally, the individual must never feel coerced to consent. If they ask for the research professional’s opinion, it should be honest but given in a way that does not pressure the potential participant one way or another.

Clinical trials continue to advance medicine, nursing, and healthcare. Without them, we would have never discovered some of the novel targeted medications for cancer, asthma, diabetes, and other prevalent conditions. We wouldn’t have HeLa cells to conduct the massive amount of cellular research for the earliest phase of clinical research. From dietary interventions that promote health, to the cure for scurvy, to continued innovations in cancer treatments, clinical research is paving the way. 

The Bottom Line

Only through hard work, transparent communication, diligent instruction, and an empathetic, compassionate attitude can we build trust in the idea of participating in clinical trials. Before individuals can make an informed decision, they must know that their team cares about them and their well-being. 

Without trust in their team, there cannot possibly be trust in clinical research, which is already stigmatized and under suspicion. The adage is true: “People do not care how much you know until they know how much you care.” In clinical research, “There is no medicine like hope, no incentive so great and no tonic so powerful as expectations of something better than tomorrow” (Orioson Swett Marden) (Changing the Present, 2024). 

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