Recruitment begins long before the study's first visit is scheduled
Think of participants in four categories
When clinical trial sites seek participants for a particular study, they often think of study subjects in one concrete way, rather than looking at the bigger picture of building a base of potential research volunteers.
"We actually have four target audiences," says Joan A. Chambers, BS, director of strategic marketing and development at Tufts University's Center for the Study of Drug Development (CSDD) in Boston.
For each of these audiences, there are specific ways the clinical research industry can enhance their involvement in research, she says.
The four categories are:
- Pre-participant: This person has heard little about clinical research other than what is in the popular media, Chambers says.
- Prospective participant: This target person is familiar with research, but hasn't participated yet, she says.
- Study participant: The study participant is someone who has participated in research and continues to volunteer in a clinical trial.
- Past-participant: Although this person has participated in a clinical trial previously, the site and sponsor have not followed up with this person, and so there is no current study involvement, Chambers says.
"When you divide it up like that, it helps to know who your target audiences are and how you are going to position your promotional material," Chambers says. "When you're trying to recruit for a new study, you may want to target the message very differently: the study participant group versus the past-participant group or the pre-participant group."
Here are some strategies for engaging each of the four groups:
1. Understand what pre-participants know.
For example, Tufts CSDD research has found that 94 percent of Americans believe clinical research is important for advancing medical knowledge, and 69 percent of the public has seen an advertisement seeking trial participants, Chambers says.
But only 21 percent of Americans believe they have a basic understanding of why and how clinical research is conducted, and less than 5 percent of Americans say they feel confident enough to begin searching for information about clinical research trials, she says.
These statistics show how there's a great deal of potential for expanding the research volunteer base if clinical trial sites and the research industry were to reach the pre-participant group.
For example, the Center for Information and Study on Clinical Research Participation (CISCRP) of Dedham, MA, has a variety of public education materials available to study participants, researchers, and others at the center's Web site: www.ciscrp.org. CISCRP also holds educational sessions in a number of U.S. cities, calling them AWARE for Annual Workshop to Advance Clinical Research Education.
Another way to reach the general public is to have professional education and outreach programs for medical professionals to distribute to their patients, Chambers says.
"These can help them educate patients about clinical research," she notes.
2. Have doctors help you reach prospective participants.
Prospective participants are the elusive group that everyone wants to understand and reach.
"Prospective participants know the risks and benefits of clinical research, but they haven't taken the initiative to participate," Chambers says.
This group can be reached most efficiently through their physician because 78 percent of them consider their physician the most trusted source for medical and health-related information, Chambers says.
"The question is, 'How can we provide information to these physicians in order for them to share it with their patients?'" Chambers says.
One solution would be a newsletter that is sent out to patients.
ForeSite Publishing of Ellicott City, MD, has developed an educational newsletter that can be mailed to a clinical research site's patients and distributed in doctors' offices. Called ForeWard, the four-page newsletter is full-color and includes engaging articles about clinical research, says Christine Pierre, RN, founder and chief executive officer of RxTrials, RxTrials Institute, and ForeSite Publishing.
The summer 2006 issue includes a cover story called "What is Clinical Research?" and an inside column called "Volunteer's Voice." A blue-boxed bullet points section answers the question "Why do they do it?" with very short answers, including "To find a cure for a disease they have."
Another section provides a short article that highlights a particular researcher and his work, and this interview-based story is how the newsletter is customized for its subscriber site, Pierre explains.
"The physician interview is on each and every one of their customized newsletters, including their names, logos, and studies," Pierre says.
"For the volunteer's voice, we have a library of volunteers we've interviewed on various aspects of research," Pierre says.
Sites can buy copies of the newsletter in increments of 1,000 per quarter, and these can be sent to patients, physician offices, or to organizations in the community, she adds.
One hundred patients selected randomly were asked to fill out a questionnaire about clinical research and their willingness to participate, and then they were sent the newsletter for three months, Pierre says.
Before receiving the newsletter, 40 percent of the patients said they were willing to participate in research, and 60 percent said they were not willing, she says.
After receiving the newsletter, the patients were asked again about their feelings toward research and, this time, the numbers had reversed with 60 percent of the patients saying they would be willing to participate in research, Pierre adds.
3. Help study participants stay invested in clinical research.
"One way to keep participants engaged is to have ongoing communication with them," Pierre says. "What's most beneficial is they really want to know the results of their participation, so having a letter that you've written, thanking them for their participation, builds an incredible relationship."
There is no immediate fix to the recruitment problem, but clinical research sites can build a foundation to a stronger relationship with subjects and future subjects, Pierre says.
"So you have a study and need to populate it, but you should be doing these foundational activities all the time," Pierre adds. "That's just good business."
The degree of emphasis that should be placed on retention is directly related to how long the subject will be on the study, Pierre notes.
"If the study is for 12 weeks, then you can do basic customer service, including being prompt, accommodating their schedule, and showing appreciation and respect of their contribution as research subjects," she says.
"If you have a study where you'll need the subjects for a year or five years, then you will need some retention strategies and programs," Pierre says.
These might include sending out birthday cards to participants, remembering them on their anniversary, maybe giving them small boxes of chocolates on the special occasions, Pierre suggests.
All of these activities will require IRB approval, and it doesn't matter how strong or grand the activities are, Pierre says.
CISCRP has promoted a "Heroes" program in which clinical trials participants are recognized and thanked for their contribution to research, Pierre notes.
"Another group gives out t-shirts that say, 'I'm part of the solution,'" she adds.
Sites that have long-term studies will need to provide some sort of recognition for participants. These could be divided into six month intervals and involve giving participants inexpensive gifts, such as t-shirts, cards, or sponsor items, such as water bottles, bags, clocks, or other items with the study's name on them, Pierre suggests.
"It's an incredible amount of time commitment on participants' part," Pierre says. "And we ask them to do a whole lot more than if they were receiving standard care in most instances."
4. Don't lose sight of past-participants.
"Unfortunately, from our survey results, we found that 88 percent of past-participants say they would participate, and 87 percent want to know the results of the study they participated in, but 79 percent say they never received any updates after the trial ended," Chambers says.
"That's a huge percentage of participants out there that had participated for a length of time and wondered about study results, but never heard back," Chambers says. "How would that make them feel about being approached again?"
This shows how there should be an initiative taken to send out follow-up notices and to say, 'Thank you for participating; we're able to share the results,' or 'We're not able to share the results,' Chambers says.
"If they're approached for a new study, and they hadn't received the results from the last one, then the new researcher can give them those results," Chambers adds.
Past-participants need some kind of closure, and they want to be treated as if they were important, she says.