Successfully recruiting participants for clinical trials is a challenge that crosses all medical disciplines, but is particularly difficult in the field of Alzheimer’s disease (AD) research. The nature of the disease, the need to recruit a caregiver in addition to the person with AD, the changing nature of clinical prescribing practices, and a climate of misunderstanding and misperceptions about AD all contribute to these recruitment challenges.
A growing body of published literature is focusing on consumer attitudes toward participation in clinical trials and benefits and barriers perceived by participants and the public. Articles report on the relative effectiveness of various recruitment tactics and methods. The value of the AD recruitment experiences reported in the published literature could be increased by the use of a framework for systematically planning and evaluating recruitment methods and approaches.
Social marketing is one such framework. It is a discipline introduced in the 1970s that seeks to apply marketing principles and expertise to address social and health problems. Social marketing is defined as a process for influencing human behavior, using marketing principles for the purposes of societal benefit rather than commercial profit. According to Michael Siegle and Lynn Doner, it is a “disciplined, audience-focused, research-based process to plan, develop, implement, and assess interventions designed to influence the behavior of target audiences to improve their personal welfare or that of society.” Like other science-driven disciplines, social marketing relies on thoughtful program design, careful implementation, sufficient documentation, and systematic evaluation to assess success and failure.
Five fundamental principles of social marketing make it particularly relevant for recruiting participants to AD clinical trials:
Know exactly who your audience is and look at everything from that group’s point of view. Most clinical trial recruiters can describe the audience they are attempting to reach, but may begin to have trouble when it comes to adopting the group’s point of view. Social marketing is a consumer-oriented and audience-focused approach to program planning. Marketers recognize that they are probably very different from the population they are seeking to recruit, and they seek to understand the world from their audience’s point of view. Understanding the specific internal and external factors of the target audience and how they influence an individual’s decision to participate in a clinical trial is a key to successful recruitment.
Be clear about the actions you want your audience to take. Marketing plans are designed with the end goal—behavior change—in mind. Often this end goal involves a series of steps, decisions, or actions. Commercial purchase decisions, for example, involve the following stages:
evaluation and assessment of options,
post purchase assessment.
As applied to clinical trial participation, these stages are:
Stage 1—Awareness or problem recognition. The participant or caregiver associates clinical trials with meeting a personal need and seeks information about the trial.
Stage 2—Information search and assessment of alternatives. The potential participant or caregiver searches for information about trials and begins to weigh the alternatives. Alternatives for AD families include continuing with current care or participating in a competing trial.
Stage 3—Enrollment. The third stage represents the actual decision to enroll and the enrollment process. It is closely linked to Stage 2 and it may occur at the same time as Stage 2 or many weeks and months later if the participant and caregiver need time to weigh the options.
Stage 4—Marketers recognize that their job does not end at the initial purchase. The same is true for clinical trials, where patient and caregiver satisfaction with the care and services provided influence retention in the current trial. Participant satisfaction may also affect the institution’s reputation, which may influence future recruitment efforts.
Participating in an AD clinical trial will almost always be a high-involvement decision with multiple consequences. For example, participating may require inconvenient and difficult hospital or clinic visits and increased time or transportation demands for a caregiver. Participants may have to stop taking current medications and switch to new drugs. Understanding the basis of high-involvement decisions can help trial planners develop recruitment strategies that are tailored to groups of participants and specific to each stage.
To succeed in getting people to do something you want them to do, you must offer them something they value in return. In a commercial transaction an exchange of value is easy to identify—a consumer gives money in exchange for a product. Social marketers must make a special effort to design and position their service so that it provides benefits that are valued by the target audience. This is particularly true in the field of clinical trial recruitment, where although most people endorse the need for clinical trials, they remain suspicious about the safety and value of the personal care offered. Marketing efforts should stress quality of care, support for caregivers, and feelings of contributing to scientific advancements as the value participants will receive.
Be aware of and plan for the competition. People with AD and their caregivers can choose a clinical trial offered by an academic research institution or a research protocol offered by a drug company. Or, they can choose neither. A clinical trial must not only provide value to that individual or family—but must provide value that exceeds the value of their other available choices. For example, providing access to support services for caregivers, easing transportation barriers to getting to appointments, or having staff who speak the participants’ language might tip the balance of decision-making and make participation in a trial a better alternative to other options.
Address all elements of the “marketing mix” in developing recruitment strategies. A successful marketing strategy will incorporate a range of tactics and approaches—known as the “marketing mix.” Four sets of variables should be considered in designing clinical trial recruitment strategy:
Product—the composite of all the services and benefits a patient or caregiver receives in a clinical trial.
Price—might include costs of transportation, extra visits to doctors, procedures and tests, and other barriers to participation such as lack of knowledge about AD, skepticism, and mistrust.
Place—the doctor’s office, clinic, or research institution the participant must visit periodically, and which includes other elements such as availability of trained staff to answer questions and provide support, accessibility, and availability of parking.
Promotion—activities should include:
Radio and newspaper advertising
Media placements in magazines or direct mail
Public relations efforts, such as making community presentations
Use of patient registries to contact potential participants
The growing field of AD research depends on a sufficient number of human volunteers, including those with AD, their caregivers, and healthy older men and women. Social marketing can provide a useful framework for designing, carrying out, and evaluating successful AD clinical trials recruitment and retention efforts. Social marketing principles can help investigators meet their recruitment and retention goals, thereby helping to ensure success of this critically important area of research.
Adapted from : Using a Social Marketing Framework to Improve Alzheimer’s Disease Clinical Trial Recruitment, Schechter, C., et. al., Academy for Education Development (in press).
Andreason, A. Marketing social change: changing behavior to promote health, social development, and the environment. San Francisco: Jossey-Bass Publishers, 1995.
Kotler P., Armstrong G. Principles of marketing. Upper Saddle River (NJ): Prentice Hall, 2001.
Siegel, M., Doner, L. Marketing public health: strategies to promote social change. Gaithersburg (MD): Aspen Publishers, Inc., 1998.
Smith, W. Social marketing: beyond the nostalgia. In: Goldberg, M., Fishbein, M., Middlestadt, S., eds. Social marketing: theoretical and practical perspectives. Mahwah (NJ): Lawrence Erlbaum Associates, Inc., 1997.