Clinical Research Recognizes Everyday People

Re-Branding Clinical Research to Recognize its ‘Everyday Medical Heroes’

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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 US Census Bureau, more than half (55%) of all Americans are taking prescription medications at the present time. Most (90%) Americans 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 dieting, exercise and lifestyle changes.

The lay public simply doesn’t realize that all medicines it consumes, and many behavioral interventions, have gone through clinical testing with people just like them. 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. But these messages are met with a large amount of indifference because they have no foundation on which to rest. The public has no context within which to understand the importance of clinical research.

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. In one recent public poll, only 14% of the American public feels that 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 believe that 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 translation of innovations into medical therapies. In the absence of study volunteers, clinical trials cannot be conducted and, ultimately, public health advances cannot be realized. An alarmingly low 4 to 6% of ELIGIBLE patients participate in US-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, 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.

 

Everyday Heroes

Large-scale public education campaigns have proven to be a highly effective strategy for changing human perception. The long-running National Milk Mustache “Got Milk?” campaign 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-littering, save the environment movement?

Clinical research needs its own ‘Got milk’-like campaign. One that is recognizable, easy-to-remember, and that can engage 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.

Creating a Rebranding Campaign

Twelve months ago, CISCRP and Fast4wD Ogilvy convened a small 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 was an affirmation that the public feels disconnected to clinical research while those orchestrating trials often forget the process has an association with physicians in the community and involves real patients. 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 primitive 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 sixty 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 run on a pro-bono basis by Princeton, NJ-based Opinion Research.

The focus groups included a 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. The hero ads also 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.

Rolling Out the Campaign

"Everyday Hero" campaigns will make their debut in a broad public service campaign being targeted for launch early next year. 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.

Our goal now is to raise $750,000 to $1 million through monetary commitments from leading pharmaceutical companies 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 billboards 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 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.