Sometimes it's hard to ask for help: How to work with recruitment firms
Keys to building effective partnerships
The statistics are not new news: "Only about 7% of sites enroll what they say they will enroll," said William Flohrs, PharmD, Associate Clinical Research Consultant, Eli Lilly and Company, Indianapolis, IN.1 "From 1997 to 2003, the studies completed on time decreased from 18% to 6%."
This performance cuts directly into the bottom line. "It can cost a company up to $8 million each day that their product is not on the market," Flohrs added. "That's not at the beginning of the cycle — the patent stage — but at the end."
According to Flohrs, "This is a result of the mishaps in the clinical trial process."
Optimizing subject recruitment is one strategy for tightening up the early stages of clinical research. To do so, many sponsors and sites are turning to the services of subject recruitment firms.
However, not all trials — and not all sites — lend themselves to the services of a recruitment firm. Understanding the role of a recruitment firm, when to bring one in, and how to develop an effective partnership was the subject of one workshop at the 44th Annual Meeting of the Drug Information Associates in Boston, MA, July 24, 2008.
"A recruitment firm's role is simple: to complement and enhance those things that are being done in the field at the sites," said Robert Loll, vice president, New Business Development, Patient Interaction, Pompano Beach, FL.2
In Loll's experience, there are a number of reasons why a sponsor or site might partner with a recruitment firm. "One reason a recruitment firm is called in is because the protocol feasibility says that recruitment is going to be a challenge, timelines are aggressive, or it's a risky study."
Regardless of the reason, to be successful a recruitment firm should have a singular focus. This, said Loll, involves driving potential patients to pick up the phone, look at the study web site, and do one of three things:
- Learn more about the research study and research in general;
- Determine if that study is right for that person with as much information and education as possible; and
- Prescreen the potential subjects.
"Prescreen is a big buzz word right now," noted Loll. "Some people want very tight use of tools, some are very liberal. It depends who you work with, but in general, they want prescreening to narrow down to the eligible subjects. That's what a recruitment firm is paid to do."
The goal is to work in partnership with sites. "A recruitment firm is 100% dependent upon the site. So it's clear what the job is," Loll said, "to make their job as easy as possible and try to make them as effective as possible."
Identifying study and site needs
So what makes a good patient recruitment company? The first assignment for a recruitment firm is to demonstrate the ability to match specialized knowledge to specific studies and sites. This begins, according to Loll, by showing necessary expertise for a particular study, which may include the specifics of the study protocol, the study site, and the inclusion/exclusion criteria, as well as geographic, demographic, and therapeutic challenges.
A recruitment firm also must present a collage of tactics that are both study-specific and site-specific. "This is particularly important," added Loll. "A recruitment firm needs to use site-optimization specialists and craft specific tactics that can be applied effectively at specific sites. One study-specific recommendation will not work at all the sites.
"You need a collage of initiatives," Loll stressed. "The reasons I believe this are because our most successful initiatives have had multiple touch points that reach out to as many potential subjects in as many ways possible in a very structured manner."
Successful firms also know how to craft messages that reach potential subjects, an increasingly difficult task given the variety and quantity of media messages today. Getting the attention of patients, Loll noted, requires that campaigns deliver creative that will cut through the advertising clutter.
Another key to success is the ability to establish partnerships with in-house and outsource resources to get things accomplished, added Loll.
Amid these key characteristics, however, Loll offered one important caveat. "All this is fundamentally accurate, but it's also misleading. What you're really looking for is people you can trust — people who are capable, people who are honest," Loll said. "You look for transparency and people who are openly candid."
Building collaborative partnerships
Loll suggests that the following themes are common to establishing effective and collaborative relationships with patient recruitment firms.
1. Take advantage of the services the sponsor makes available. For the site, this means identifying and taking advantage of the assets and tools that will help them get the study up and running.
- Data metrics: It's important to do this as judiciously as possible. "We do a lot of lifestyle segmentation analysis of potential subjects," noted Loll. "We try to learn as much as possible about the perspective patients. By doing so you can target your messaging and deliver copy that is closer and much more relevant to your audience."
- Incidence and prevalence rates: "Whenever I have the opportunity to learn more about where these individuals are living I take advantage of it," Loll said. "I'm a huge fan of grabbing those ICD-9 codes whenever possible."
There are many companies that specialize in this service. "They will help you identify those subjects by ICD-9 codes and where they are.
"Most of the sponsors are using that information to determine which sites to use," added Loll, "which physical location where they want to do the research."
- High prescriber information: "We're also taking advantage of high prescriber information," Loll said. "If I can't reach out to the particular people with a condition, I'll try to reach out to the physicians who treat those individuals."
2. Outreach tactics and initiatives. Here, there are multiple options: outdoor, street, community, and point-of-sale (pharmacy) campaigns. "There may be a number of ways to reach out to an individual," Loll noted, "but it must make sense for the therapeutic condition being studied."
- Study web site and on-line screener: "I'm a huge fan of leveraging the internet because your patients are out there on the internet. But I don't want you to be dependent on the internet," said Loll. However, in light of the regulatory issues and control in those environments, he's less enthusiastic about the Web 2.0 and the social networking sites.
Branded micro-web sites may be most helpful when it comes to education. "No one decides to become involved in clinical research in a vacuum," he noted. "They're talking to friends, they're talking to family, they're talking to neighbors, loved ones, physicians. The web site needs to help with credibility and the process of making the decision to participate."
- Physician outreach, community and advocacy outreach, patient registries: "If these efforts make sense, do them," Loll said. "We tend to do a lot of direct mail. I'm a fan of that and think it makes sense if you can identify the potential subjects and get that list to mail to them directly."
- Recruitment materials: Again, it's imperative to offer a collage of materials that can be used to reach potential subjects. "These tools are hard to cost-justify," noted Loll. "But it's important to offer materials that patients can take home and look at away from the physician's office. I'm also a big fan of versioning, customizing these materials."
- Office tools: These are things that can be done at the site to make the lives of the study coordinator and PI easier. For example, Loll said, "If you get someone who is confused or has missed the flow, it's the recruitment firm's job to put together a study guide to make it easier for them. Patient education materials and patient retention items, these are things we can do to make the their job easier."
- Advertising: Again, it's about multiple touch points: newspaper, radio, TV, on-hold messages. Loll offered one note of warning: "Be careful with banner ads. There are some people who will tell you that you can get a million impressions, but that's meaningless to you because what you're looking for is that screen pass.
"I tend to do as many tactics and initiatives that are geo-specific and targeted as possible," added Loll. "For some studies, people might drive 250 miles, for others maybe only 25 miles."
3. Create a relationship with the sites. When a sponsor spends the time to find out what they can do to make a site successful and works to create a relationship with the site, it makes a tremendous difference, said Loll. "So when I talk about doing study- and site-specific things, you have to talk to the sites and find out what you can do that would make the site more successful."
It's important to find out what the barriers are. "That will help the recruitment firm craft specific agenda items, specific tactics that will work for the site."
4. Identify what other high-performing sites are doing and take advantage of best practices. "Consider developing and implementing initiatives that are working at other sites," suggested Loll. "Some people are creatures of habit and don't want to do tactics that have not been done before. If that's the concern, do a pilot. When you hear a story about a site in Kansas City that's doing something well, find out what's going on."
Loll also stressed the idea of sharing tools whenever possible. This starts with finding out what materials are available and knowing what's in the tool kit. "Some tactics are automatically done, but some are at the site's discretion," Loll noted. "Having said that, someone might want to go do a wrap around all public telephones. Well, there may not be any public telephones in that area. Everyone is using cell phones.
"As long as you have a discussion and the tactics make sense, we'll do everything we can," Loll said. "Talk with the sponsor about going ahead and implementing those ideas."
5. Be open to referrals generated from a centralized campaign. "This is a paradigm shift for some," noted Loll. "There are some that understand that we can provide 10%, 20%, or 30% of the target population and there are others still to this day that think it's not very many. Those are the purists. They want everything to come from their internal database and that's not always possible. It's our job to distill those inclusion/exclusion criteria down from three pages into very specific messages that enable the pre-qualification process.
"It's not enough that I tell people that you're running a study, they have to engage as well," Loll added. "They have to contact that site, get on-line with that call screener. They have to engage and there has to be a change in behavior.
"It's important that the staff understands. They love inclusion/exclusion cards and flow charts. This is helpful. And that's the purpose: to make this as easy on the staff as possible."
6. Take advantage of organizations that support the clinical research industry. There is no shortage of examples of bad PR, Loll pointed out, but clinical research professionals can help by supporting organizations that work to improve the image of the clinical research industry. "For example, CISCRP [Center for Information & Study on Clinical Research Participation, www.ciscrp.org], can help us overcome the burden that some people don't trust clinical trials. It's non-profit, in multiple languages, and has tons of items available to you.
"Even though the study coordinator and the PI are comfortable talking about clinical research, the person at the front desk may not be," noted Loll. "So I love the assets of CISCRP and how they can help overcome the misperceptions within this industry."
References
- Flohrs W. Thirty ways to increase enrollment at your site. Boston, MA: 44th Annual Meeting of Drug Information Association; July 24, 2008.
- Loll R. Utilizing a patient recruitment firm. Boston, MA: 44th Annual Meeting of Drug Information Association; July 24, 2008.
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