Q: What is a clinical trial?
A: Clinical trials are research studies that involve people. According to the National Cancer Institute, “Through clinical trials, doctors find new ways to improve treatments and the quality of life for people with disease. Researchers design cancer clinical trials to test new ways to: treat cancer, find and diagnose cancer, prevent cancer; and manage symptoms of cancer and side effects from its treatment. They are the final step in a long process that begins with research in a lab. Before any new treatment is used with people in clinical trials, researchers work for many years to understand its effects on cancer cells in the lab and in animals. They also try to figure out the side effects it may cause.”
Q: Why and when did clinical trials come into being?
A: The need for clinical trials protections resulted from previous abuses of human subjects. For example, the Nuremberg Code (1948) states that “the voluntary consent of the human subject is absolutely essential,” particularly, subjects must give consent and the benefits of the research must outweigh its risks. The code was a response to the actions of 23 German physicians and administrators for their willing took part in war crimes against humanity, according to The University of Missouri Kansas City. (Most of the subjects of medical experiments conducted on prisoners of war died or were permanently disabled as a result.)
The first clinical trial sponsored by the National Cancer Institute, for patients with acute leukemia, took place in 1955.
Q: How are human subjects protected today?
A: Stringent standards and the ongoing assurance of adherence to those standards are in place, from the governmental (federal) level all the way down to the institutional level. “All UIC clinical research investigators and staff are required to take regularly-scheduled trainings to remain abreast of the latest standards and practices,” says Angie Allred, Interim Director of the Oncology Clinical Trials Office at the UI Health Cancer Center. Training modules include what’s known as “Good Clinical Practice” standards. As part of training, federal guidelines, and regulations are applied to the real life practice of clinical research.
Q: Define “informed consent?”
A: Except for certain emergency situations, informed consent must be given by every participant entering a clinical trial. It features several key components, including (but not limited to): information on how the trial will be carried out, including all procedures and treatment involved; which part or parts of the study are considered research (“investigational”), any physical or emotional risks associated with procedures or treatment; confidentiality of records, information about what will happen to any research specimens after testing is complete; and acknowledgement that the person participating in the research study has had the opportunity to discuss the study with a healthcare professional.
One of the most important aspects: Participation always is voluntary and the decision to participate will not affect the quality of care received.
Q: How does an Institutional Review Board (IRB) promote high ethical standards in clinical trials?
A: An IRB ensures compliance with relevant laws and regulations; ensures participants are respected and protected; makes efforts to secure the well-being of clinical trial participants; verifies that each study selects participants equitably; provides guidance in research design and scientific integrity; determines if the research contributes to generalizable knowledge
and is worth exposing subjects to risk and; ensures the clinical trial maximizes possible benefits and minimizes possible harms.
Importantly, IRBs were developed as a response to the Tuskegee Study, begun in 1932. According to the Centers for Disease Control and Prevention, “The study initially involved 600 black men – 399 with syphilis, 201 who did not have the disease. It was conducted without the benefit of patients’ informed consent. In truth, they did not receive the proper treatment needed to cure their illness. In exchange for taking part in the study, the men received free medical exams, free meals, and burial insurance. Although originally projected to last 6 months, the study actually went on for 40 years.”
The establishment of IRBs helps demonstrate the intention to conduct research responsibly.
Q: What is the role of trust in an individual’s decision to participate in a clinical trial? How can the medical community advance trust, particularly with minority populations?
A: Community and patient mistrust in research is rooted in the historical experiences of certain populations. However the situation has improved over the years and continuing progress is evident. At UI Health Cancer Center, for example, the Office of Community-Engaged Research and Implementation Science (OCERIS) is laser-focused on community outreach. “We’re working on a simple goal,” says Karriem S. Watson, DHSc, MPH, MS, and Director of OCERIS. “Be better. Educate more people. Navigate more patients. Serve more communities. OCERIS supports the engagement of underserved communities to improve cancer outcomes, research, education and training.”
Milestones such as the Nuremberg Code and the 1952 Kefauver Harris Amendment (a requirement for drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval) were turning points in ensuring great patient safety, but inequity in the system continued over many years. For example, not until 1993 did Congress pass a law a based on the NIH policy that women and minorities must be adequately represented in clinical trials.
Q: Why is it so essential that minorities participate in clinical trials at a much higher level?
A: An article published by the Association of American Medical Colleges, titled “More Minorities Needed to Make Research Relevant,” reports that minorities account for fewer than 10 percent of patients enrolled in clinical trials, according to the NIH National Institute on Minority Health and Health Disparities. Unless and until a growing number of people in minority populations participate, the medical community cannot ensure that new research, treatments, interventions, and prevention strategies will be relevant to these populations.
A case in point from the NIH Cancer Genome Atlas: African-American women have a 40 percent higher breast cancer mortality than other women, and studies have shown that these women have biological risk factors including certain genetic mutations that make their breast cancers more aggressive. These studies underscore the critical need to involve higher numbers of African-American patients in precision medicine research to find out why these differences lead to worse clinical outcomes. By gaining a greater understanding of the genetics of breast cancers that disproportionately affect African-Americans, researchers and others can develop novel targeted therapies that may reduce racial disparities in breast cancer outcomes.
Q: In what other ways can greater trust be developed?
A: It’s human nature for individuals to identify and communicate more easily in a setting that reflects their community. Having some members of a clinical research staff who are culturally congruent helps ease the way; for instance, an African American patient navigator or a Latino physician.The importance of maintaining a physical presence in the minority communities a health care organization serves is also essential. For example, UI Health’s Mile Square Health Center treats patients in their own neighborhoods – Englewood, Back of the Yards, Cicero, Humboldt Park, South Shore, and many more locales (as well as at school-based clinics).
UI Health Cancer Center’s recently launched Patient Brigade consists of a group of cancer patients and survivors who communicate directly with cancer center staff about their experiences as cancer patients – what works, what doesn’t, and more. These individuals will soon have some direct contact with UI Health Cancer Center researchers.