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    Debunking 5 Clinical Trial Myths You May Have Heard

    There’s a good chance you’ve heard the term “clinical trial” before, whether it came up in your doctor’s office, in an advertisement, or even on this very website. But as common as this phrase is within the medical field, its meaning may not be entirely clear to someone who is not a health care professional or who works in the health care industry. So, what is a clinical trial? Let’s start at the beginning: At its core, a clinical trial is a study that answers specific research questions related to an investigational medicine or treatment. Clinical trials are integral to health care, as they allow scientists to better understand health conditions and determine whether new drugs, diagnostics, medical implants, or other treatments are safe and effective. Even if you’re new to clinical research, it is not uncommon to find that your initial perception of them is shaded with uncertainty. That’s because, despite the importance of clinical trials, there is an alarming amount of misconceptions surrounding them. The best way to determine whether clinical trials make sense as part of your health story is by demystifying them. For Blood Cancer Awareness Month, we discussed clinical trials with Brandon Blue, MD, an expert in health disparities and multiple myeloma, to look at a few common myths and learn the facts, as well as the role these trials play in the future of Oncology—and across medicine in general. Myth #1: Clinical trials are not safe. Researchers, along with the pharmaceutical companies, academic organizations, and research hospitals that sponsor clinical trials, must follow strict rules and ethical guidelines. In the United States, these guidelines are set by the Food and Drug Administration (FDA), a government agency charged with regulating trials and approving therapies or diagnostics before they become available to the public. Additionally, each clinical trial is reviewed and monitored by an Institutional Review Board (IRB), which is an independent panel of qualified, unbiased health care providers and researchers. The purpose of an IRB is to help ensure that trials are conducted ethically and that the rights, safety, and welfare of trial participants are protected throughout the process.¹ It’s also important to note that all treatments available to the public today started out in clinical trials. Dr. Blue emphasized that even when the pace of drug development is particularly fast, as it is in his area of specialty, Oncology — “every day a new cancer drug is either getting developed or approved,” he noted—the clinical trial process helps ensure that safety is prioritized. Dr. Blue emphasizes “all [approved] medications needed to be tested in order to know that they are safe and that they work.” Speaking specifically to someone who believes that clinical trials are not safe, Dr. Blue would note that “it is important for patients from diverse backgrounds to participate in clinical trials, so we know how these investigational medicines may work for the patients that will use them, especially those of color.” Taking part in a clinical trial may be the right choice for some cancer patients. If you choose to participate in a clinical trial, you should be informed of what to expect, the potential benefits and risks of participating, and why the research is being conducted. If you enroll in a trial, you can change your mind and withdraw at any time. Myth #2: Diversity in clinical trials is not important. Over the years, we’ve learned how important it is for cancer clinical trials to include people of different sexes, ages, races, and ethnicities. This is because our bodies may react differently based on these factors. In the United States, research has shown that racial and ethnic minorities, particularly Black Americans, have worse outcomes in multiple types of blood cancer.² As Dr. Blue points out, “Many times this is due to the fact that, for many cancers, minorities get diagnosed at younger ages and at more, advanced stages than others. 3,4 However, minority groups have the lowest clinical trial enrollment numbers.” It’s imperative that clinical trials reflect the diverse population of people with the health conditions they’re studying in order to help researchers understand how effective and safe a treatment is for those who need it. It must be acknowledged that historical failings in the clinical research field, including the infamous Tuskegee Study run by the U.S. government from 1932 to 1972, have contributed to continued public mistrust in the research process. Though the ethical standards lacking in the past have seen tremendous overhauls over the past decades, including stronger regulations and the creation of the Office for Human Research Protections , the medical community and pharmaceutical industry are committed to continuing to rebuild meaningful trust with patient communities. 5 Knowing the importance of transparency and building trust in achieving diversity, equity, and inclusion (DE&I) in clinical trials, the Diversity, Equity and Inclusion in Clinical Trials (DEICT) team at Janssen Pharmaceutical Companies of Johnson & Johnson strives to be a leading force in educating the public on the clinical trial process and why diversity and inclusion is important in clinical trials. Their “Research Includes Me” program focuses on reaching underrepresented and underserved communities by meeting them where they are and addressing barriers to clinical trial participation. To learn more about the clinical research process and why diversity is so important to the future of medicine, visit ResearchIncludesMe.com . Myth #3: Clinical trials are not developed with people like me in mind. The need for representation in clinical trials has become much more apparent in recent years, and there are many different efforts underway to deliver on that need. So that everyone has a seat at the table in clinical research, government agencies, including the FDA and the National Institutes of Health in the United States, have expanded their efforts to promote inclusivity in clinical trials. Included among the medical community’s DE&I efforts is placing an emphasis on ensuring that the staff administering clinical trials – including Oncology clinical trials – are more reflective of the populations they serve. Dr. Blue underscores the importance of having diverse populations develop and lead cancer clinical trials, noting that “Culture is key! You cannot teach culture in medical school; it’s something that is passed down from your family and life experiences.” As representation grows across the medical field, especially in positions of power and among medical professionals leading research projects, a patient’s sense of feeling seen and heard in the clinical trial process will grow with it. 6 Through the program, Better Trials . Made Together., Janssen is co-creating better trial experiences by facilitating deeper connections among patients, investigators, and others. By asking and listening, they’ve found there are commonalities for both patients and investigators across their trial experience, regardless of geography or disease state. And these commonalities (or voices) have helped them change how Janssen approaches, plans, and executes clinical trials for underrepresented and underserved communities. Myth #4: The only way to participate in a clinical trial is waiting to be recruited into one. It is true that many researchers actively seek out participants, and it is also true that some people enter trials on the recommendation of their doctor. However, patients are also able to seek out relevant clinical trials on their own and request information to see if the study would be a good fit for them. There are many trial search tools that are free and easy to use. If you are interested in searching for suitable clinical trials in your area, you can search ClinicalTrials.gov . At any given time, there are thousands of clinical trials actively recruiting patients across the United States alone. Available trials can vary across a wide range of health conditions, age groups, study lengths, and geographic regions, so even if there is not a clinical trial that immediately suits your circumstances, it is worth checking periodically as availability may change. If you would simply like to learn more about the clinical trial process and familiarize yourself with patient rights, more information can be found on ResearchIncludesMe.com . Learn More Myth #5: My participation in a clinical trial doesn’t really make a difference. Clinical research impacts us all, even if we aren’t immediately aware of the advancements they drive. From life-saving medical technologies and medications to products like sunscreen, you have clinical trials to thank! Given the nature of research, there are no guarantees that a trial will bring about the desired results, but each study contributes to a wider pool of medical knowledge that can benefit current and future patients across the globe. To those considering a clinical trial, Dr. Blue says, “Thank you for not only considering yourself but the future of the medical field. The only way that we will find a cure to cancer is if everyone thinks of others. I would also say the information we learn today could help one of your family members in the future, and your involvement could teach us something that could save that person’s life.” Whether you are considering a cancer clinical trial for you or your loved ones, the decision to participate in any research study is a highly personal one. That places extra importance on accurate information—participants need to be aware of everything that happens during the clinical trial process, their rights, and how to determine if a trial is a good fit for each individual, based on their own health condition and other factors. One resource that can help in this process is Janssen’s clinical trial fact sheet , designed to help patients speak with their health care professionals. Click the button below if you are interested in further information that can help educate and assist you in making decisions about clinical trials: explore more with janssen References ¹ What Are Clinical Trials and Studies? National Institutes of Health. https://www.nia.nih.gov/health/what-are-clinical-trials-and-studies . April 9, 2020. Accessed August 2022. ² Cancer Disparities. National Cancer Institute. https://www.cancer.gov/about-cancer/understanding/disparities . March 28, 2022. Accessed September 2022. ³ Age At Cancer Diagnosis For Blacks Compared With Whites In The United States. Journal of the National Cancer Institute. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4326308/ . January 29, 2015. Accessed September 14, 2022. 4 A collaborative study of differences in the survival rates of black patients and white patients with cancer. Cancer. https://pubmed.ncbi.nlm.nih.gov/1562983/ . May 1, 1992. Accessed September 14, 2022. 5 The U.S. Public Health Service Syphilis Study at Tuskegee: Research Implications. Centers for Disease Control and Prevention. https://www.cdc.gov/tuskegee/after.htm April 22, 2021. Accessed August 2022. 6 Diversity & Inclusion in Clinical Trials. National Institute on Minority Health and Health Disparities. https://www.nimhd.nih.gov/resources/understanding-health-disparities/diversity-and-inclusion-in-clinical-trials.html . February 7, 2022. Accessed August 2022.