Failure to Communicate

Three friends are talking over lunch. The first person declares, "I'm donating blood," to which his friends reply, "That's good." The second says, "I'm donating an organ." They all agree that it's great. When the third person announces, "I'm participating in a clinical drug trial," his statement is met with silence, confusion, then skepticism.

Why the different responses?

Part of the reason surrounding patients' reluctance to become clinical-trial participants stems from a lack of direct and reliable information about clinical studies. Compounding that problem are the primary care community's reluctance to encourage patients to participate and pharma's negative image, which together have snowballed to create a shortage of clinical-trial volunteers. Without those volunteers, companies cannot bring new drugs to market. So industry needs to acknowledge the imperative—and embrace the opportunity—to present the positive attributes of clinical-trials participation through targeted, thoughtful, and aggressive communications.

Perception vs. Reality

Companies' reluctance to communicate information about clinical trials—combined with the sensationalism of consumer media—have overshadowed the benefits and successes of clinical-trial participation. High-profile stories involving drug-study conduct and misinterpretation of study results affect patients. One only has to look at early reporting of data from the Women's Health Initiative as an example. When information came out about possible side effects of the hormone Premarin, the media headlines screamed that the hormone caused heart disease, which caused widespread fear and panic. Stocks plummeted and funding immediately was halted. Although research later indicated that Premarin did not cause heart disease in women, the public already had a negative perception about the drug. This scenario proves that powerful messages can affect patients, physicians, and stock prices negatively by creating a disincentive for funding in areas that are being attacked.

Acting the part: An Iris Global model shows three distinct volunteer types, based on responses from patient focus groups on the likelihood of participating in a clinical trial.

As the industry remains silent, the media has stepped in to "educate" consumers and practicing physicians. When consumer media do cover a specific clinical trial, the focus is often on scientific breakthroughs or other advances that may very well be far off.

Plus, the story they're telling is not complete. Consumer groups don't understand why today's drugs are expensive, and they lack perspective on what it takes to get a new drug into their prescription bottles. As a result, the industry has a widespread patient-enrollment problem. The result is delayed trials—in fact, 80 to 90 percent of all clinical trials are delayed—and a more costly research and development process.

It's not that communications efforts fail to target consumers. Mass advertising and public awareness about specific clinical trials has grown in refinement and effectiveness. But too often pharma leaves the clinical-trials communication up to investigation sites, which have scant resources and little direct-to-consumer experience. The result: ineffective ads that confuse instead of encourage potential clinical-trial participants. The public is left wondering if they have to surrender their current medications. Must they get permission from their physician, or worse, lose their physician loyalty? How will they find time away from work? And finally, are they just a pharma guinea pig?

Trials as Mainstream Medication

In an ideal world, primary-care physicians could be the solution to the dearth of trial volunteers. They're the key link to consumers. Focus groups have shown repeatedly that most patients prefer or require their physician's consensus before volunteering for a clinical trial. Patients cite the "trust" factor when considering participation. However, the majority of physicians in the United States are not involved in clinical studies, nor are they aware of specific trials available to patients.

Doctors in focus groups say they want to keep it that way. The primary reasons doctors keep their patients in the dark about clinical trials are their own lack of knowledge on the subject and their fear of losing patients to another treatment center. The majority of doctors also say they decline to refer patients because studies offer them no opportunity to share in the research. And they're also concerned that trial participation is time consuming and inconvenient.

According to a national study conducted on behalf of the Advancing Parkinson's Therapies (APT), the majority of physicians who treat Parkinson's do not refer their patients to clinical trials—even though most agree that it helps discover better remedies. Accordingly, very few patients report that their physicians have suggested participation in a clinical trial. Until practicing physicians incorporate the education aspects of clinical trials into mainstream medicine, patient referrals to investigation sites will be almost non-existent.

When you get down to it, this unwillingness to refer patients can be traced back to a lack of the most basic information about clinical trials. Most primary- care physicians indicated they would consider referring patients to a trial only if the study sponsor sent information about the trial, possible benefits and risks of the treatment, and if they highlighted opportunities for doctors to participate in the research. Unfortunately, study sponsors rarely reach out to practicing physicians about studies in their communities.

Solutions Are Here

We cannot change the negative incidents, but the benefits of clinical-trial participation can be related through consistent public education. Positive messaging can have a significant impact on how quickly new therapies enter the market. The task isn't difficult, but it does require companies to have the courage to get out and open the doors of communication.

The importance of awareness, collaboration, and participation require a concerted effort among small groups. But until recently, these initiatives were implemented independently and inefficiently.

Educational seminars Pre-education programs are an effective way to help potential participants gain knowledge about a future trial. The "Aware for All" program is a one-day educational conference developed by the Center for Information and Study on Clinical Research Participation (CISCRP), a non-profit organization conceived by co-founder and chairman Ken Getz. The program encourages consumers to meet with investigators, learn more about various clinical studies, understand the potential study treatment options, and learn concepts like informed consent, risk-benefit ratio, and participation. Since establishing the program three years ago, CISCRP has seen significant interest among the public wanting to learn more about clinical research.

Pre-education programs can take the form of investigators presenting at grand rounds or network meetings. Letters sent to colleagues on a regular basis are effective ways to pre-educate physicians and nurse practitioners. But it's vital to communicate to consumers as well. The public needs reassurance about the benefits of participation and how the potential treatment may improve their quality of life. Instead of the current methods of filling the short-term goal of completing a specific study, the research communities need to take a longer-term view to increase future interest in trial participation.

Recruitment database In particular, pharma can do this better by following up with previous participants and educating them about future trials. Their exposure to the first trial enables them to experience that clinical studies typically do not pose significant health threats, so it's surprising that few—if any—comprehensive, relational databases have been developed for investigators to tap into for future trial recruitment. If the industry can apply the methodology used for observational trials—when companies track patient progress over time—to create a database for recruitment, the trial process can become more efficient. Companies can use this populated database to communicate with past participants, educate them about future trials, and even thank them for their participation—which can go a long way in building long-term relationships.

Clinical-trial registries The 2004 institution of clinical-trial registries initially was viewed by some companies as another restriction imposed by the federal government. Pharma previously was not required to list every single trial they were conducting, and some felt the information overflow was confusing. But, in hindsight, clinical-trial registries offer the industry an opportunity to educate consumers, demonstrate the complexity of clinical trials, and perhaps trigger interest in participation—if they can use registries for educational purposes in addition to just compiling a list of trials.

The scarcity of accurate information keeps the public ignorant, but education is the easy remedy. Informed consumers may want to discover new treatments by participating in clinical trials.

Kathleen Drennan is senior vice president and managing director of Iris Global Trial Solutions, a division of Corbett Accel Healthcare Group. She can be reached at kathleen_drennan@iristrials.com