Of all the techniques considered for affecting the behavior of patients and encouraging their clinical trial participation, nary a single researcher has considered the benefits of dissuasion. It is true on its face the concept seems a bit counterintuitive. After all, typical recruitment approaches involve persuasion, enticement, inducement and have, during less proud times, inched closer toward undue influence. What has not yet been explored is the benefit of dissuasion, or discouraging participants from refusing to participate in voluntary clinical research.

Critics contend that this approach is likely to be misconstrued and experienced as undue influence, coercion and exploitation. The industry regularly points to the horrifying medical experiments conducted by Nazis during WWII and the Tuskegee syphilis experiments as evidence for all that is wrong with more aggressive recruitment tactics. They maintain that there is an inherent human tendency toward abuse of power among researchers and others who are not kept under tight regulatory control and who may be permitted to more actively market their clinical trials.

More optimistic recruiters maintain a different view. They believe that with proper counterbalancing of education and training, enhanced and more aggressive recruitment may be benefits to all involved. Drawing primarily from social psychology and marketing literatures, several key components of a successful dissuasive recruitment campaign begin to surface. Perhaps most important is what may be gleaned from research on the use of negative affect for persuasion (Huang, 1997). This research provides powerful evidence of the potential negatively affecting ads have for predicting persuasiveness. Three sets of affective responses toward three graphic and unpleasant Benetton ads were measured to test distress attitudes toward ads and fear/jitteriness factors experienced by respondents.

Results indicate that in predicting persuasiveness of negatively affective ads, it is important to take the concurrent nature of the types of negative affect and their directions of persuasiveness into account. Perhaps an even more significant finding of this research is that the practice of advertising unpleasant feelings per se generated by negatively affective ads may not be sufficient for consumer persuasion.

It is the attention generated by these unpleasant feelings that gives rise to the persuasiveness of negatively affective ads. Simply put, by using negatively affective ads, marketers successfully create an enormous level of brand awareness which commonly translates into an increase in sales. Based on the findings outlined here, recruiters are urged in the short-term to consider beginning experimentation with placement of negatively affective advertisements.

It seems the timing could not be better for such experimentation. Given the near daily accounts of negative effects of sundry medications, both within and without clinical research, there seems ample opportunity for placement of negatively affective ads. An example of the kinds of ads the author is proposing may be described using the recent Avandia crisis involving Glaxo-Smith Kline...

In May 2007, a now commonly cited New England Journal of Medicine article sparked considerable controversy with its findings of increased risk of cardiovascular side effects related to the use of the Avandia product (Nissen & Wolski, 2007). As a recruiter, the author observed a curious phenomenon related to this controversy. Not only were patients beginning to take increased notice of the medication and ask more detailed questions about Avandia, but they were also more inclined to seriously consider participation in clinical trials.

What is even more curious is that the effect the controversy appeared to have on trial participation seemed to linger; that is, she presently continues receiving questions about the Avandia product as a result of this early and memorable exposure. Based on her observations, the author believes there is opportunity for extending the effects that negative publicity have for enticing patients to participate. For instance, it does not seem beyond reason to suggest that a tasteful but dramatic advertisement depicting a patient experiencing an adverse reaction to Avandia and a physician standing nearby, ready to intervene would not produce even more fruitful opportunities for increased education about and participation in clinical trials.

Although there is scant research on the use of dissuasion in clinical research, use of negatively affective advertising is not without precedent in the field of health care. On the organizational or social level, positive effects of the Performance Initiative, an innovative contractual approach to recruiting participation in family planning programs at rural health centers in Ruwanda, suggest positive benefits to what would ordinarily be viewed as negatively affective personnel inducements (Meesen et al., 2006). Transforming from an outmoded individual provider bonus system, researchers assessed the effects of a facility-based performance system. Researchers initially encountered considerable resistance to the change, particularly from providers who perceived it to be punitive. While limitations in study design contributed to a failure to produce positive outcomes in individual patient behavior, the study managed to achieve overall success through the performance-based payment system which boosted the performance of all 19 centers involved in the study.

The researchers attribute the exceptional success of several centers to a shift from individual fixed bonus systems to a facility output-based scheme that with buy-in from providers managed to create the perception that there were gains to be had by collaborative and alternative forms of inducement. On the individual or biological level, the only clinical trial using a dissuasion-type design involves the use of probiotics for discouraging or preventing antibiotic diarrhea (www.clinicaltrials.gov, 2007). While it attempts to discourage a natural biochemical response to a clinical agent, it lends additional support for the dissuasion research proposed by the author. Indeed, a recent press release indicates that research is being conducted on both probiotics and their counterpart bacterial microbes for chemical dissuasion (Daily Hampshire Gazette, 2007). It would appear that the only sphere in which dissuasion is not being explored is in patient recruitment!

Still further reason for the advertising changes being proposed here is based upon the author’s belief in the growing ineffectiveness of well established industry advertising techniques. Throughout her work she has observed what little effect the continued liberal use of brand-name labels affixed to freebies, gadgets, and deliverables have on patient preference or brand loyalty. Patients are regularly observed using items provided and failing to recall anything about the sponsor associated with the product. Moreover, it appears that there is a tendency for some patients to behave in ways that are contrary to expectations, actually being turned off by the blatant and “positive” advertising presently used by pharmaceutical sponsors.

Another example is the recent reference by clinical staff to a pharmaceutical representative as a “walking, talking taco” upon greeting him at the industry-sponsored Mexican-style lunch. The representative quipped, “I don’t care what you call me as long as you keep writing those scripts.” Industry appears out of step with the increasingly savvy patient and staff populations it serves. Although it is commonly accepted by participants in all levels of clinical research that traditional branding approaches are ineffective and, some would even say, laughable, there is a perpetuation of the status quo and reticence to discuss new marketing approaches.

Perhaps even more germane to this discussion are present policies guiding industry in their use of particular marketing approaches. Today’s policies guiding recruiters are well-intention yet arguably paternalistic, largely informal and outmoded. They have a tendency to produce unintended, inconsistent and, at times, perverse results. For instance, despite their growing importance to the pharmaceutical industry, 50% of all proposed pediatric clinical trials are aborted for want of patients. The primary reason cited for participation refusal is parental fear of the risks associated or pain involved in the trials. It is the author’s belief that parents are unnecessarily fearful and lack sufficient education to guide them in their choices.

Alternatively, present paternalistic policies have a contrary effect on some patients who may be affectionately referred to as “pharma entrepreneurs,” patients who participate in clinical trials, serially. These individuals, the author suspects, subscribe to beliefs that are attributable to unintended consequences of the protectionist bent of present trial policies which “sex up” trial participation (Mulgan, 2007) by giving the appearance of significantly restricting participation and by perpetuating a somewhat false belief that patients will be lavishly treated and incur significant material benefit as a result of their participation. Of course these misperceptions may also be resultant of the image the pharmaceutical industry has for lavishness and wealth.

Another more insidious problem caused by present policy relates to the near-exclusive focus on outcome measures (i.e., informed consent and recruitment rates) that obscures an appreciation for other relevant considerations which can have disastrous effects on patients. Though the reasoning for Annas’ believing thus is not made entirely clear in the review of his book An American Civil Liberties Union Handbook,( Maschke, 2004), he makes a good point about the dangers of industry over reliance on the act of obtaining formal consent. He attributes the death of Boston Globe reporter Betsy Lehman to medical errors as a result of the medical team’s preoccupation with administration of her informed consent and lack of attention to other aspects of her care. His argument may be extended further and addresses fundamental questions about the nature of consent. Research on the nature of consent has not yet produced definitive definitions and offers up two possibilities. These are defined as mentalistic and behavioristic—that is, consent is wholly a state of mind or comprised totally of behavior (Husak & Thomas, 2001).

Although these definitions and the underlying ideas are beyond the scope of this article, suffice it to say that there are diverging views about the act of agreeing or, for sake of argument here, refusing to participate in clinical trials. It is precisely at this level that further discussion about the utility of and potential for abuses through alternative forms of marketing need to be addressed. Through careful planning, increased dialog and education, and intentional experimentation with negatively affective ads, the author contends, all of these alleged problems could be alleviated.

Dissuasive techniques offer specific benefits for recruiters. Working in an environment that is increasingly flexible, especially with respect to greater fluidity between work and non-work spheres, recruiters often experience considerable job stress. Recent research examining identity accumulation, others’ acceptance of one’s aspired self, work role salience, and job-search self-efficacy in relation to job stress found that others’ acceptance has direct, significant, and negative relationships with job stress (Lang & Lee, 2005). Enhanced opportunities for dialog and education of all participants in the clinical research process—patients, sponsor representatives and principle investigators—are especially beneficial for recruiters. It is expected that dissuasive advertisements will offer enhanced recruitment opportunities for recruiters, including a broader array of techniques useful for connecting with patients and others who have diverse personality styles, experiences, and preferences.

Another possibility is the use of more organizational level dissuasion tactics akin to the Rwandan health centers for development of workplace training and merit systems, something the author found is sorely lacking in present community-based clinical trial centers (Higgins, 2007).

With respect to training in particular, it is the author’s belief that with preparation in the use of negatively affecting ads (as well as more traditional ads), recruiters will be better prepared to handle potentially volatile or emotionally charged situations, whether on- or off-site. They will also be better equipped to modulate the workplace feedback loop between “leaders” and “followers” (Rivka et al., 2007).

Much more research is needed on recruitment techniques. Examples of the kind of research projects that would be more beneficial are impact studies of the effects of dissuasion, versus more traditional recruitment techniques, on recruitment and retention rates. More detailed measurement of negative affect by discrete scales in order to detect the possible subtypes of negative affect and their directions of persuasiveness are also needed. Impact studies of workplace interventions involving dissuasion on personnel behavior and a recruiter productivity rate is also needed. Still further research needs to be conducted on the management, leadership and attachment styles of recruiters and the utility of dissuasion for enhancing or detracting from these styles (Shedler et al., 2003). Finally, research is also needed on the degree to which recruiters engage in self-regulation when using diverse recruitment techniques.

What is perhaps most unfortunate about the present failure to embrace new marketing approaches is the cost it ultimately creates for all involved. An important consequence for industry is the effect stagnation has on timely release of quality products. This can be observed through the occurrence of a relatively new phenomenon, “evergreening,” which thwarts release of superior products (Brody, 2007).

In anticipation of the possible introduction of new and improved products by competitors, patent-holding companies begin identifying ways in which their product may be used to treat comorbidities, or co-occurring disease, resulting in the creation of products called “two-fers” (Brody, 2007). Such wise patent applications could perhaps be viewed as legitimate protection of intellectual property rights, however, these applications are often refused and serve only to delay, not prevent, more effective and efficient products from entering the market. It is the author’s belief that the exorbitant fees produced by these machinations and which are passed on to consumers are unnecessary and wasteful.

She further maintains that through the use of creative and alternative marketing strategies like those presented here industry would actually contain cost while simultaneously stimulating increased clinical trial participation, speeding up product development and increasing profit. Improved recruitment policy reforming the present outmoded protectionist bent is a good way to achieve all of these goals and perhaps the only way of meeting the demands of a changing trial landscape and cultivating steady streams of patients.

References

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