Medical Device Link.

Originally Published MX November/December 2001

ADVERTISING, DISTRIBUTION, & SALES

Winning at Clinical Trials: It Takes a Lot of Patients

Effective strategies for recruiting people for investigative studies are based on empathy.

Matthew Kibby

A healthcare product manufacturer setting up a campaign to market a new device or drug must recognize that potential customers do not so much shop for a treatment as make a decision about their healthcare. It is imperative that a sponsor make the same distinction when undertaking to recruit patients into a clinical trial for its investigational product. Overlooking the emotional context in which healthcare decisions are made, the manufacturer could alienate its target audience even before introducing the first patients to the product during the clinical trial phase of development. Product marketers organizing a patient-recruitment campaign for a clinical trial must, put simply, understand the patients’ point of view and communicate in the language of their experience.

But how can they know what is going through the mind of a person suffering with a particular condition unless they are themselves experiencing that condition? A good clinical trial planner bridges that gap for the trial sponsor.

Critical trial planning—a matter of marketing the trial to prospective patient enrollees—can mean the difference between falling short of participation goals and completing enrollment in the trial well ahead of schedule. A trial planner can be either a department of the manufacturing company itself or a hired outside service provider.

This article explains how an effective planning process uncovers insights that guide a marketing program toward successful implementation, with a particular emphasis on the patient. It reveals how a strategy derived from these insights can translate into the mixed-media tactics likely to recruit a sufficient number of appropriate, qualified trial participants. Once the best tactics are established, the manufacturer will have enough basic information to create a patient-recruitment budgeting structure. This article also provides tips and techniques on budgeting successfully (see sidebar).

The Heart of the Matter

The process of recruiting patients begins with a quest for the kind of information that can be usefully employed in a marketing program. Imagine a professional trial planner reading the testimony of a woman who underwent a double mastectomy to combat breast cancer, the heart of which is capsulized in the following excerpt.

[My daughter] came to me, took my hand, and led me to the couch that she and Dad were sharing. No one said a word. I had just showered and was drying off, and I was curious to look at myself for the first time since my surgery. What I saw really shook me. I had just seen the sutures from a double mastectomy. My daughter looked at me and said, ‘Mom, everyone is entitled to one good cry.’ Then I stood there and started to cry—no, sob. I felt an overwhelming relief after that cry. All that built-up tension, anxiety, fear, and concern I’d felt with every biopsy of the past 10 years was gone. I was in total control again. . . . This sounds so simple, and in theory, it is. The real problem is doing it. So, no matter if you feel really scared, first allow yourself one good cry and then take control.¹

A physician investigator, a site coordinator, a clinical scientist, or a clinical research organization coordinator who has not gone through such a profound surgery, no matter how articulate he—or even she—might be, probably could not describe this woman’s experience in quite so powerful or moving a way. On the other hand, a planner working on a campaign to recruit women who have been diagnosed with breast cancer to the trial of an innovative treatment method would quickly recognize in this testimonial the bedrock upon which to build a strategy: "First allow yourself one good cry and then take control."This simple statement speaks volumes about the patient’s overall experience with her condition.

How Planners Work

In a way, planning for a clinical study is like prospecting for gold. The trial sponsor should look at everything: not just the words of a patient, but also the tone and attitude with which they are conveyed. Taken bit by bit, this input may not seem to amount to much, but when brought together in context, the accrued facts and impressions form an accurate representation of the patient experience. Ultimately, this valuable ore can be refined into a compelling message that will resonate with the target audience.

Clinical trial planning is the art of thoroughly understanding the target audience of a recruitment campaign. Of course, planners investigate objective facts and statistics regarding a condition, and the outward circumstances of seeking help for and treating that condition. But more important than that, planners gather subjective information about being a patient. They learn how patients think, feel, and communicate about their condition, and how they act in response to it. This kind of work can involve typical forms of primary research, such as focus groups, private conversations, and man-on-the-street interviews. But a little more creativity may also be in order. Trial planners may attend meetings of patient support groups, visit on-line newsgroups, or even ask patients to sketch their experience of their illness.

A patient recruitment campaign is not simply about finding prospective clinical trial participants. Even more important is knowing what to say to them when they are found. Communication with patients seeking critical healthcare answers must be effective in order to hold their attention and win their trust.

Gaining Insight for Recruiting Strategy

Prospecting for the essential nuggets of the patient experience uncovers the best method for communicating with patients. The next step is to glean from this valuable information the insights that point toward an effective patient-recruitment campaign strategy. A strategy based on genuine insight into the patient character will prove to be a cohesive plan for choosing appropriate recruitment tactics to implement.

For example, in a women’s-health recruitment campaign, the challenge was to overcome the embarrassment associated with a medical condition called menorrhagia—excessive menstrual bleeding. The facts were sobering: one out of five women experiences menorrhagia, a condition so thoroughly debilitating that sufferers are held hostage in their own homes for days or even weeks. So why were many women so hesitant to seek information about a clinical trial of a new treatment option for their condition? Preliminary planning investigations uncovered several insights into why recruitment was such a challenge. One was that women who suffered from excessive menstrual bleeding simply had no idea that the word menorrhagia was the clinical term for their condition. Furthermore, their symptoms were so embarrassing to them that many would rather have suffered in silence than talk to their doctor to learn more about treatment options.

Figure 1. The tag line for this women’s-health recruitment campaign brings the issue of menorrhagia to light, encouraging the audience to look for treatment options and take control. (Click to enlarge)

In this case, insights revealed by the planning process made a solid strategy clear. The issue needed to be brought out into the light with an honesty and empathy that would raise eyebrows and hope. The tag line captured the underlying spirit of the campaign: “Your period doesn’t have to be a sentence.” Using television and print materials that encouraged the audience to look for choices and take control, this campaign advanced the cause of the trial sponsor by inspiring an overwhelming patient response (see Figure 1).

Information generated by investigative planning provides the means to discuss with patients the value of participating in a clinical trial in language and a format that they can easily understand. It can be the foundation of an effective patient-recruitment campaign. The planning phase of a recruitment program uncovers critical evidence to guide decision making for tactical implementation. In fact, one of the best ways to measure the success of the planning process is by judging how easy it is to settle on the most appropriate tactics. The more comprehensive and on target the early information gathering is, the more self-evident will be the tactics for acquiring study enrollees.

Implementing Insights

When tactics to market a clinical trial to candidate patients are implemented successfully, the recruitment program achieves reach, frequency, and credibility through a variety of media. A tactic is a medium used to generate a message. Tactics available for ãpatient recruitment include television advertising, public relations, direct mail, advocacy outreach, and radio. A mixed-media approach involves artfully choosing tactics that strategically complement and support each other in a campaign to attract the attention and interest of target audiences.

The medium is certainly part of the message in soliciting patient involvement in clinical trials. For example, use of such public media as radio or television to reach patients with chronic constipation—who are extremely private about their condition—might be far less effective than a direct mailer arriving in a discreet envelope. Radio announcements, on the other hand, might be an excellent tactic for reaching diabetics with retinopathy, a disorder that limits visual acuity. Following are some typical clinical trial recruitment challenges with anecdotal accounts of tactical successes in reaching target audiences and securing enrollees.

The Hard-to-Reach Target Audience. Some studies need to reach patients with whom, for a variety of reasons, it is difficult to communicate. People with bipolar disorder are an example. They can be exceptionally hard to engage because their condition often predisposes them to distraction. Recruiting from this population requires a high degree of sensitivity.

Figure 2. The campaign materials for a bipolar study—poster, direct mail, and ads—expressed empathy for patients in a bold and colorful design, and conveyed a sense of hope. (Click to enlarge)

Groundwork conducted for a clinical trial recruitment program revealed that bipolar patients relied heavily on close family and friends to make decisions about their health. The recruitment campaign therefore was designed to reach this unexpected primary audience. Advertising and direct mail established an identity for the study. Community outreach to support groups made contact with family and friends at a grassroots level, providing an environment in which to communicate potential benefits of the study for their affected loved ones (see Figure 2).

The Healthy Patient. How can people who are in good health be encouraged to participate in a medical research study of a compound that is designed to treat an overall rather than a particular condition? The question was one faced by the sponsor of a study for a hormone medication designed to slow the effects of aging on several anatomical systems.

The strategy that emerged was to educate seniors about the fact that maintaining muscle mass to avoid injury is as important as retaining bone density to fight osteoporosis. Because older adults crave health information, the hormone manufacturer chose a direct mail brochure as the tactic likely to be most effective. Clearly approachable and extensively educational, the brochure communicated with seniors without the hard sell of advertising. This effort was supported by uplifting radio, print, and public relations messages in appropriate markets (see Figure 3).

Figure 3. The definitive health story of an investigational hormone drug was the basis of campaign materials that promoted the study by educating seniors about their health. (Click to enlarge)

The Onerous Protocol. In some studies, the requirements of the protocol may loom as a barrier to participation. One trial sponsor wanted to boost lagging recruitment for a peanut allergy study. The requirement that was the biggest obstacle was that participants would have to ingest peanut protein, a prospect that appeared to put them at risk of suffering a severe allergic reaction.

The campaign launched to solve this case first raised public awareness of peanut allergy and then promoted the study as being championed by institutions with national reputations in allergy treatment. A major publicity initiative was designed to reach a broad population. Supporting the recruitment campaign were broãchures and a Web site that explained the requirements of participation and drove response (see Figure 4).

Figure 4. Spearheaded by a PR initiative and supported by a Web site, brochures, and discussion groups, this campaign for a peanut-allergy research study focused on raising awareness of the condition and its effects while alleviating the fears of potential participants.

The Unrecognized Condition. Millions of older Americans suffer to some degree from clinical depression, but the harsh reality is that a depressive state is assumed to be a normal by-product of aging. It is often overlooked or dismissed by healthcare providers, family members, and even the sufferers themselves. A clinical study investigating a treatment for depression in the elderly was 80% underenrolled and faced a tight deadline. How can patients be reached whose condition may not be universally recognized as an illness?

Because of the short scheduling time frame and the need to illuminate the real medical issue for a society mostly unaware, public relations was the sole tactic ãemployed to recruit study participants. A media blitz was conceived, developed, approved by an institutional review board, and launched in a matter of weeks. Picked up with enthusiasm by a press hungry for health-related news, the story of the effort to put together a trial for the new treatment quickly reached the broad audience of elderly sufferers. The recruitment campaign was supported by the study sites in each market in highlighting depression as an ailment distinct from Alzheimer’s and other conditions of aging.

Conclusion

Successful organization of a patient-recruitment campaign for a clinical trial depends on tailoring the campaign to patients’ experience of the malady whose treatment is under investigation. This planning strategy can generate insights to be used in developing tactics that will resonate clearly with the desired target audience. When the patients’ perspective is clearly understood and their voice is represented faithfully in the campaign, a clinical trial sponsor can speak to its audience empathetically and effectively. And the messages that recruit patients for a trial that can be started on time and on budget can ultimately be deployed to market the approved product when it is released for sale.

1. As told to Matthew Kibby by an anonymous woman during an alt.support.cancer.breast news group discussion [on-line], fall 2000; available from Internet: http://www.cancersupporters.com/ascb.

2. B Brescia, "Budgeting and Contracting in Patient Recruitment," in A Guide to Patient Recruitment: Today’s Best Practices and Proven Strategies, ed. Diana L. Anderson (Boston: CenterWatch, 2001), 73–92.

Matthew Kibby is director of creative strategies at BBK Healthcare Inc. (Newton, MA), a marketing communications firm for the medical technology industry.

Copyright ©2001 MX