By Ruthie Barreau
Historically, scientists have made immense strides in understanding how different diseases affect the human body. Many of these insights point toward promising new strategies for the treatment, prevention, and diagnosis of countless diseases. Every clinical study contributes valuable knowledge, whether or not the treatment works as hoped, but because of the importance of clinical research trials, they are often referred to as the engine that powers medical progress.
Today, the general population has come to expect and demand a continuous production of new drugs that are safe and effective. Improved medical treatments can never become a reality without testing in human volunteers. However, the participation rate in clinical research trials remains low. This problem is one of the main challenges faced by clinicians, researchers, and clinical trial recruitment professionals. In recent years, the fraction of eligible subjects recruited to clinical research trials has decreased worldwide, resulting in the postponement of trial completion and making the projective universality of trial results unpredictable.
Low participation rates in clinical research trials are an even greater problem when it comes to minorities. The scale of the problem is largely unknown, undoubtedly multifactorial, and not welldocumented. According to the Centers for Disease Control and Prevention (CDC), in 2009, minority participation in clinical research trials has traditionally remained lower than that of the Caucasian race in clinical research trials. Because clinical research trials provide the dataset that informs physicians of the judicious use of new drugs, exclusion or minimal involvement of minorities means that important information on the proper use of drugs will not be available for various ethnic minority groups, adversely affecting their health. Health statistics concerning minorities suggest that the health status of groups such as African-Americans or blacks, Hispanics, American Indians, Asians, Pacific-Islanders, and other ethnic minorities have not kept pace with those of nonminorities.
Unfortunately, these same populations also bear a disproportionate burden of disease morbidity and mortality. For example, according to the CDC, death due to heart disease is more than 40% higher for African-Americans, American Indians, and Alaska natives than that of whites. Hispanics living in the United States are almost twice as likely to die from diabetes. Asians and Pacific Islanders experience more cases of hepatitis and tuberculosis (while on average, considered the healthiest population groups living in the United States) than do whites. Women of Vietnamese origin suffer from cervical cancer at nearly five times the rate for white women. Without adequate representation of these populations in clinical research trials, researchers cannot learn about the potential differences among groups nor ensure all medical treatments and therapies are reliable, valid, and generalizable across various ages, genders, and ethnicities.
What Causes Someone To participate In A Study?
Determining what contributes to a potential participant’s decision to partake in a clinical research trial has been an elusive challenge. This decision is alleged to be based on a potential participant’s perceived threat to their health and the degree to which a potential participant believes that trial participation will be effective in reducing that threat, given the perceived effectiveness of the existing standard treatments/therapies. Accordingly, it is important to consider potential participants’ perceived barriers and benefits to changing versus maintaining usual healthcare behaviors in order to understand how to increase positive change and results.
In reviewing research studies conducted on the subject matter of clinical research trial participation and ethnic minorities, three key themes emerge from empirical literature between 1992 and 2009. Scholars have documented how research abuse and misuse, such as the legendary Tuskegee syphilis study, have contributed to a culture of distrust concerning minority participation in clinical research trials. In 1992, James H. Jones mentioned that no scientific experiment inflicted more damage on the collective psyche of black Americans than the Tuskegee syphilis study, but studies that solely reference the Tuskegee syphilis study represent a disproportionate view of what factors completely contribute to low participation in clinical research trials across various age groups, genders, and ethnicities. While ethnic minorities manifest experiences differently — in other words, they are not homogeneous — there are also differences among each minority group. A closer look at the Tuskegee syphilis study provides valuable information, particularly to the theme that allays concerns about “another Tuskegee.”
A second theme that emerges from the literature concerning ethnic minority participation in clinical research trials is fear. For example, a study examining attitudes toward clinical research trials (with 41 participants and 47 nonparticipants of past cancer clinical trials) found that fear of the unknown and unease with the randomization process of clinical research trials are primary reasons for choosing not to participate. The importance of a trusting relationship between the patient and clinician, researcher, or scientist should not be underestimated because patients fear that the information they receive concerning a study does not always accurately describe the benefits and risks of clinical research trials participation.
Having sufficient information about a study and understanding that lack of information is the third key theme that emerges from the literature related to ethnic minority participation in clinical research trials. Several researchers found that ethnic minorities such as African-Americans have limited knowledge about research and a lack of understanding and trust of the informed consent process. Corbie-Smith et al. in 1999 found that participants did not understand the concept of informed consent; participants perceived consent as an agreement to relinquish their autonomy as a legal protection for researchers and funding institutions to abuse participants. Ten years later, Sood et al. also found that the language of consent documents and protocols may be too technical for many to understand, and this contributed to further distrust and fear of participating in clinical research trials.
Not Your Standard Recruiting Strategies
Recruitment of varying age groups and genders in the different ethnic minority groups calls for more than the standard recruitment efforts and strategies. Standard recruitment strategies usually involve advertisement campaigns, creative educational materials, direct-mail outreach, referral management, and various research center-specific supports, but these may not be culturally acceptable or appealing to various age groups and genders in ethnic minority groups. It is chiefly essential for the clinicians, researchers, and clinical recruitment professionals to be mindful of ethical issues, cultures, beliefs, behaviors, and personal experiences with past participation that arise when conducting clinical trials with ethnic minorities. Tailoring a recruitment strategy to a targeted patient population is important, especially, when the targeted population includes ethnic minorities. Tailoring the clinical trial recruitment strategies includes individualizing health communication content based on participant demographics such as gender, age, and ethnic background. Understanding the different attitudes and factors that primarily influence decision making in various ethnic minority groups across different age groups and genders related to clinical research trial participation may help clinicians, researchers, and clinical trial recruitment professionals to better design recruitment strategies that improve minority participation.
About the Author
Ruthie Barreau is a global trial optimization manager at Merck. She is currently working toward completing her doctorate in health science Seton Hall University. She has a B.S. in biochemistry, an MBA, and a master’s of science in clinical research science-epidemiology. She has also worked for Pfizer, Novartis, and Schering-Plough.
Used with permission from Life Science Leader magazine.