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Applied Clinical Trials
A new patient recruitment campaign depicts trial volunteers as heroes and aims to both educate and win over the public.
For the lay public, clinical research is not typically a topic of dinner table conversation. It's not discussed in high school science classrooms. And it's usually only discussed in a doctor's office when a patient has been diagnosed with an illness for which no available treatment exists or for which available treatments are unpleasant, unsafe, and ineffective.
Yet arguably, clinical research touches every person's life regularly. According to the U.S. Census Bureau, more than half of all Americans (55%) are taking prescription medications at the present time. Most Americans (90%) report routinely using over-the-counter medications. And most Americans (85%) state that they recently read an article or heard press coverage of clinical studies recommending new approaches to improving health through diet, exercise, and lifestyle changes.
The lay public simply does not realize or understand that all medicines it consumes—and many behavioral interventions—have gone through clinical testing, involving people who have volunteered their participation. Indeed, although the majority of people believe that clinical research helps advance medical knowledge, less than 15% believe they have even a rudimentary understanding of how clinical research affects them directly.
Ubiquitous patient recruitment ads on metro trains, in big-city newspapers, on the radio, and in health communications bombard the public frequently. An estimated half a billion dollars is spent annually on mass media patient recruitment advertising and promotion. These ads are designed to recruit for specific studies, and yet it is clear that the broader understanding of the benefit of clinical research is neither widely considered nor appreciated by the public. For this reason, specific study messages are met with a large amount of indifference: They have no foundation on which to rest. The public has no context within which to understand the importance of clinical research.
This public service ad for CISCRP was rated highly among focus group members, beating out campaigns featuring sports stars.
Extensive media coverage of drug withdrawals and their aftermath; conflicts-of-interest among FDA members and research professionals; questionable pricing practices; and tragic errors resulting in harm to patients have left the public confused and troubled. Public sentiment toward the clinical research enterprise is at an all time low. One recent public poll revealed that only 14% of the American public feels pharmaceutical companies are "Honest," a rating similar to that bestowed upon the tobacco and used car industries. In another 2006 poll, more than 70% of Americans said they believe drug companies put profits ahead of patient needs.
The clinical research enterprise faces its greatest crisis ever: widespread distrust. Without public and patient support, there can be no realization of innovations in medical therapies. In the absence of study volunteers, clinical trials cannot be conducted or they are severely delayed and, ultimately, public health advances are not made. An alarmingly low 4% to 6% of eligible patients participate in U.S.-based clinical trials annually.
The clinical research community has largely failed to respond to poor public perception and eroding public trust. Professionals affiliated with research sponsor organizations, with service providers, educators, regulatory agencies, and human subject protection programs have been insular in their approaches to addressing the crisis. They have focused on better professional training, on accreditation and certification, and on improving the disclosure of conflicts-of-interest and the accessibility of clinical research information. But the magnitude of this crisis demands a response designed to educate the lay public and to "rebrand" clinical research as a valuable public good.
Large-scale public education campaigns have proven to be a highly effective strategy for changing human perception. The long-running national milk campaign "Got Milk?" has used a string of celebrities to promote milk consumption. The "This is your Brain on Drugs" campaign, featuring those famous fried eggs, has affected at least two generations' views on the dangers of drug abuse. And who can forget the crying Indian, whose tearful face in the 1970s television commercials became a powerful symbol of the anti-litter, save the environment movement?
Focus Group Reactions to Everyday Heroes
Clinical research needs its own "Got Milk"-like campaign—one that is recognizable and easy to remember, and engages the public in thinking differently about clinical research. Such a campaign has been a top initiative at the Center for Information and Study on Clinical Research Participation (CISCRP) during the past 12 months.
With an unrestricted educational grant from Eli Lilly and pro bono collaborative support from Fast4wD Ogilvy—a division of international advertising and marketing agency Ogilvy & Mather—CISCRP worked extensively with a large and diverse group of research professionals and patient advocacy organizations and conducted consumer focus groups to arrive at the most effective clinical research rebranding message: "Everyday Heroes." To a wide cross-section of the population, print advertisements that call out ordinary individuals as heroes piqued interest and curiosity in addition to sending the message that being a part of clinical research is a good and even noble thing to do.
Other campaigns tested were less likely to get across the idea that an everyday person can help save lives. Those featuring study volunteer heroes alongside recognized sports heroes were polarizing and unpopular. Another campaign that used an eye-catching red superhero cape blowing on a clothesline was confusing to participants and some perceived the cape as trivializing the message of everyday heroes. A campaign picturing a long line of people coming together to advance medicine tended to raise more questions than it answered. Another showing remedies for everyday ailments was confusing and viewed by some as promoting homeopathic drugs.
Like the "Got Milk?" campaign, "Everyday Heroes" will unfold nationally as a series of engaging, general educational messages. As such, one of the key challenges is to maintain a long-term perspective that the goal of the campaign is to build consumer awareness and trust in the important role that clinical research plays in advancing medical science, and to change public perception and appreciation of the clinical research volunteer. The purpose of this campaign is not to recruit volunteers into currently enrolling studies or promote newly approved treatments. This campaign must focus on early education and on establishing a relationship and a connection with the public. What follows is a detailed discussion about the development of the Everyday Heroes campaign.
Eighteen months ago, CISCRP and Fast4wD Ogilvy convened a small diverse group in Washington, DC, to talk about the difficulties in patient recruitment and retention and how that related to public education failures. That initial meeting brought together about two dozen people representing patient advocacy groups, the U.S. Food and Drug Administration, the National Institutes of Health, PhRMA, the National Health Council, academic institutions, pharmaceutical companies, CROs, investigative sites, patient recruitment service companies, and the IRB community. Fortunately, the dialogue remained constructive, the views largely shared, and the mindset determined to move forward.
This initial meeting highlighted the unified view that not only does the public feel disconnected to clinical research but also that those orchestrating trials often forget the process has an association with physicians in the community and involves real members of the public. There was also consensus that study volunteers deserve recognition and appreciation for the profound gift that their participation provides for others. Most study volunteers want to know that they're making a valuable contribution to science. Yet few research centers stay connected to volunteers after a trial has ended.
At the conclusion of the small group meeting, Fast4wD Ogilvy reviewed attendee observations and suggestions and developed 15 different campaign ideas, called "Treatments." These treatments cut across a wide spectrum of educational approaches—some serious, some shocking, and some quite humorous, including one campaign that tried to capture how far advances in medicine had come. This campaign juxtaposed several old and new treatments, such as a pile of cow dung for severe skin burns against modern treatments made possible by millions of clinical research volunteers.
Four months later, another meeting was held among nearly 60 research professionals representing all stakeholder groups involved in the clinical research enterprise. This large group spent a full day reviewing, discussing, and modifying the 15 treatments. At the end of the meeting, the group had winnowed the campaign choices to five. After incorporating suggestions and refining the campaigns to make them look polished and professional, the five treatments were presented in March 2006 to consumer focus groups.
The focus groups included a representative mix of ages, genders, ethnicities, lifestyles, and occupations, and individuals were grouped into one of three socio-economic classes. The "Everyday Hero" campaign scored significantly higher across the board. Consumers liked the concept and felt appreciative of the people featured in the campaign. Also, the hero ads most prompted them to want to learn more. Among the lower socio-economic group, in particular, respondents identified with and admired the featured "Heroes."
The copy on the final version of the campaign reads, "Medical heroes can be found in ordinary places. Together we can make a difference through medical research." Based on the request of many focus group respondents, the campaign also gives viewers a telephone number and a Web site where they can learn more about the clinical research process.
"Everyday Hero" campaigns will make their debut in a broad public service campaign being targeted for launch in 2007. Heroes still under consideration for the other two ads include a person working behind a desk in an office setting, a teacher in an elementary school classroom, and a senior citizen in a social setting. The CISCRP logo and contact information will appear on the ads. The FDA has expressed interest in having its logo on the campaign material.
Our goal now is to raise $750,000 to $1 million from leading pharmaceutical companies and government agencies to underwrite first-year campaign costs. The ads will run on a discounted basis in major consumer publications like Time, Newsweek, Reader's Digest, and Prevention as well as on billboards, bus shelters, and bus backs in high traffic areas like Manhattan, Chicago, and Los Angeles. Banner ads will likely also be placed on commercial Web search engines and high-traffic consumer sites like Yahoo and WebMD.
CISCRP and Fast4wD Ogilvy intend to conduct follow-up research on the campaign's impact on public perceptions about and public interest in clinical research. Over time, provided that this campaign achieves the reach and frequency planned, we're hopeful that ongoing public opinion will reflect a better-informed populace, greater appreciation of the value of clinical research to public health, and deeper recognition of research volunteers.
The authors wish to thank David Davenport-Firth, director of Ogilvy Healthworld, for his creative leadership in developing this campaign.
Kenneth Getz,* MS, MBA, is a senior research fellow at the Tufts Center for the Study of Drug Development and the chairman of the Center for Information and Study on Clinical Research Participation, both in Boston MA, (617) 590-4175, email: Kenneth.email@example.comEmma Sergeant is group managing director of Ogilvy Healthworld in London, UK. James Kremidas is the director of global enrollment optimization at Eli Lilly and Company, Indianapolis, IN.
*To whom correspondence should be addressed.