As seen in the August 2011 edition of Life Science Leader magazine.
By Ruthie Barreau
The field of clinical research starts and ends with the patient volunteer. Unfortunately, there is a paucity of research volunteers for participation in clinical trials. Because of the valuable and innovative products intended to fill unmet medical needs, you would think patients would line up around every hospital block to enter clinical research trials and possibly receive potentially life-saving treatments.
The reality is not that simple. Patient volunteers are increasingly scarce and even more limited when it comes to minority patient participation in clinical research trials. According to the Centers for Disease Control and Prevention in 2009, ethnic-minority participation in clinical research trials has traditionally remained lower than that of Caucasians in clinical research trials. Lack of ethnic minority participation in clinical research trials is of particular concern in light of the fact that health statistics concerning minorities suggest that the health status of groups such as African-Americans, Hispanics, Indians, Asians, Pacific-Islanders, and other ethnic minorities have not kept pace with those of Caucasians. There is, obviously, a problem. The problem in this case is understanding how to continually improve recruitment efforts that serve as a pedestal specific to successful recruitment, especially that of the minority population.
How can we improve our current processes of minority recruitment? Are we recruiting in a vacuum? Is there a need to reinvent? Designing recruitment strategies with the goal of improving minority participation continues to include the understanding of different key factors that primarily contribute to and influences a person’s decision to participate in a clinical research trial. Three foremost conceptual frameworks are imperative to review if one is to understand the decision-making process of clinical trial participation. The following section describes three theories that attempt to explain the decision-making process of potential patient volunteers.
Recruiting Patient Volunteers: An Attempt To Theoretically Explain The Decision Toward Participation
In 1998, Verheggen et al. presented an extended version of the Health Belief Model (HBM) that attempts to explain the decision-making process for clinical research trial participation. This model describes three primary considerations that influence how patients process information regarding health and their expectation of health status. This model suggests that an individual’s background and social context influences his/her belief toward 1) general health, 2) healthcare, and 3) the ability to minimize health problems. Verheggen’s extended version of the HBM also suggests that behavior toward participation depends mainly on a patient’s belief of a value proposition and outcome expectancy; in particular, subjective health considerations determine whether people perform a specific-health related action. If an individual believes that a specific-health related action will treat a condition or a disease, and there is some beneficial value, then there is a higher likelihood of partaking in a clinical trial. But, if that belief does not exist, then the odds of participating in a trial decrease.
In 2003, Brown & Topcu combined aspects of the Theory of Reason Action and the Health Behavior Model to attempt to capture the decision-making phenomenon of trial participants. According to their model, the extended form of the Health Services Utilization Framework, some individuals will have a greater propensity to participate in a clinical treatment study than others will, and this propensity is likely to vary by demographic, social structural factors, and sociocultural factors, as well as a person’s previous experiences within the healthcare system. The extended form of the Health Services Utilization Framework integrates the characteristics of a population that independently predicts a person’s willingness and behavioral intention to participate in a clinical trial. This framework depicts the healthcare system and external environment as a combined factor that independently impacts one’s predisposing characteristic, enabling resources and illness need, which ultimately establish behavioral intention toward participation. Notably, the extended form of the Health Services Utilization Framework recognizes that the external environment, including its physical, political, and economic aspects, specifically affects the way in which an individual utilizes healthcare services. Predisposing characteristics would include those that contribute to the foundation of personal beliefs, attitudes, and knowledge. Brown & Topcu’s extended form of the Health Services Utilization Framework describes enabling resources as all-inclusive factors associated with making an informed decision to participate, including feedback, approval, and support from peers or others. This framework also proposes that individuals with greater illnesses would be more likely to take part in a clinical treatment research trial than those with fewer or no symptoms, which includes a person’s analysis of the perceived need and benefit in participating in a clinical trial. Illness need not only encompass disease diagnosis, but also the person’s beliefs about the disease and perceptions of severity.
A third possible theory of explanation is the Precede-Proceed Health-Education model by Green & Kreuter in 2005, which is a widely used conceptual underpinning to train informed consent administrators. This conceptual theory suggests there are three initial components, which are mediators and moderators necessary for changing a person’s perception toward the informed consent process of trial participation. The initial key components of the Precede-Proceed Health-Education model suggest that strategies and activities to change perception toward the informed consent process of trial participation should include an assessment of 1) predisposing, 2) enabling, and 3) reinforcing factors that are relevant to the specific group of interest. According to Green & Kreuter, these three connecting factors are necessary when seeking to explain or understand what influences, what allows, and what strengthens/supports the decision to participate. Similar to the extended version of the Health Services Utilization Framework, Green & Kreuter note predisposing factors to include those that contribute to the foundation of a person’s personal beliefs, attitudes, and knowledge. Enabling factors are those relating to the skills necessary to perform a function or skills that allow the ability to make an informed decision toward participation. Reinforcing factors are associated with feedback, interaction, and approval from peers or other important people (in this case- potential research participants like themselves, family members, caregivers, primary-care physicians, and other members of the research staff/team) that strengthen and support patient understanding of trial participation. The Precede-Proceed model summarizes that there are primary preceding factors that serve as constituents for understanding participants’ perceptions of trial participation based on the informed consent process.
These theories provides alternative lenses through which to explain factors and hypotheses related to the decision-making process of a patient volunteer toward clinical trials among various populations. Thus, no one theory alone sufficiently explains all factors that contribute specifically toward the likelihood or willingness to participate in a clinical trial, but with the foundation of these theoretical explanations we can begin to understand how to design recruitment strategies that will ultimately improve and reinvent the recruitment of the minority population.
Patient recruitment is no easy task. The success of any pharmaceutical company or any organization conducting clinical trials is contingent upon adequate patient enrollment. But remember, any recruitment strategies you strive to implement and adopt that are specific to minority populations must conform to ethics approval and oversight.
About The Author
Ruthie Barreau is currently working toward completing her doctorate in health science at Seton Hall University. She has a B.S. in biochemistry, an MBA, and a master’s of science in clincial research science-epidemiology. She has also worked for Merck, Novartis, Pfizer, and Schering-Plough.