Experts agree: Think recruitment through
Hot tips for warming up recruitment
You’d think it would be easy to recruit patients for studies — just put an ad in the paper or talk to patients at the clinic. Everyone wants to help science advance, right? Maybe, but that doesn’t mean they want to be a subject in a clinical trial.
According to data reported in How to Grow Your Investigative Site, by Barry Miskin and Ann Neuer, published in 2002 by CenterWatch, it now takes about 4,400 patients to bring a new drug to market. Further, while some 3 million people per year begin studies, only 700,000 finish what they start.
"About 80% of studies have to extend enrollment periods by at least a month," says Claire Driscoll, MBA, executive vice president at CliniCall Patient Recruitment services in St. John, New Brunswick in Canada.
Her company manages phone contact with patients and recruits them for studies through a call center. She has seen many of the mistakes that organizations make regarding patient recruitment. "One of the biggest problems I see is that people think if they hire a call center, patient recruitment will go through the roof. That’s a misconception," she says. "It’s only one part of a well-rounded strategy that you have to create before you even begin a study."
Indeed, problem No. 1 according to Driscoll, is most investigators and coordinators have no recruitment strategy at all. "A lot of people think they can choose just one thing, like putting ads in the paper or doing Internet recruitment. Worse, they’ll say they’ll just let the investigators do it for a while, and then if they run into problems, they come to us."
That creates some large challenges, she says. First, if it is a rescue effort, costs go up and time becomes critical. Money may become even more of an issue if the investigator did not budget for the contingency.
"You can’t just try stuff willy-nilly," Driscoll says. "Start at the beginning, figure out who you are trying to reach, and create an appropriate strategy for getting to them." Recruitment, she adds, should be one of the first things an investigator and trial administrator discuss.
"A lot of investigators just kind of assume that recruitment will happen," says Beth Harper, MBA, senior vice president of global operations at Diane Anderson Company, a clinical trials consulting firm based in Dallas that specializes in patient recruitment.
Start with an in-depth assessment of the study and the targeted patient population, she says. "Make sure you have gone through any database of patients to identify patients who might meet criteria from the start."
Next, consider other physicians or investigators in your community who also might know some good potential patients, Harper says. "If you have a network, tap into it."
Only then should you consider which outside resources to use. Among potential strategies: advertising, placement of articles in the paper, and attendance at local health fairs, Harper continues. "Understand the potential sources for your patients and then put in place a plan for reaching them. Before you begin, estimate how much time it will take, what materials you’ll use, and how much money you’ll need to recruit the patients you require."
Harper says a frank discussion with the sponsor about resources required is a must. "Will you have to hire someone to go through charts and databases? Do you think you’ll need to hire a call center? How much will you need for advertising?" Getting additional funds after the study starts will be much harder than answering those questions at the beginning and asking the sponsor for the appropriate funds then.
Another requirement: Make sure you get your recruitment materials approved early. It can take as long as four months, says Harper. "People often think if they just get through the regulatory paperwork, they’ll be fine. But there are often materials that the ethics committee will have to approve, too."
Another problem Driscoll commonly sees is an overestimation of what it takes to get people involved in a trial. "Investigators will tell you they know 15 people who would be just great for the study. But converting good candidates into people who want to participate in a clinical trial is neither easy nor instant," she says. "Chances are you won’t convince all 15 of them."
If you are overseeing a multisite study, be sure to keep in touch with all the sites and monitor how recruitment is going at each. If one particular site is having trouble getting its share of patients, knowing early will help to identify the problem and correct it before your study becomes one of that 80% seeking an extension on the enrollment period.
Harper says administrators and investigators should have weekly meetings about recruitment to see where a study stands and what action, if any, needs to be taken to keep recruitment on track.
Large organizations, such as universities and academic medical centers also may have resources available to assist in patient recruitment. For instance, they may be able to help set up an Internet site to prescreen subjects or provide a toll-free number for screening.
If you do end up using a call center or other organization to help with recruitment, make sure your expectations of what they can do and how fast they can help are not unrealistic. "We can only generate referrals based on the calls we get, and the media planning drives that. If we’ve done the media part of the recruitment, too, it’s not as much of an issue. But if the media doesn’t target the right people then we might get hundreds of calls but few appropriate patients."
Part of what drives how successful efforts are is the difficulty of the protocol. If it’s a simple one, the screen might take under a minute, and 200 calls can generate 150 potential patients. But harder protocols can require 500 people screened to get the same number of prospective subjects.
Call centers also may offer other services that can help with patient retention. For instance, CliniCall offers appointment setting and appointment reminder services, says Driscoll. "If they offer services like that, take advantage of them."
The costs for these services will vary widely, depending on the complexity of the study, the time frame in which recruitment needs to be completed, and any ancillary services you opt to sign up for. Regardless of what you choose to use, make sure you check references. "If you ask and they won’t give you numbers to call, I would go elsewhere," Driscoll says.
Harper says letting a recruitment service know about your past recruitment efforts is key to building a successful relationship. "They should know what has worked for you in the past and what hasn’t," she says.
The more you work with the company, the better the campaign will be. You can even work with them on the prescreening script, adds Harper. "Provide good feedback. Tell them how you want the relationship to work, what you need to see in advance, and if you have any good contacts for advertising."
Once you have a potential subject, keeping them involved in the study is often based on making sure they have a realistic understanding of the study. Harper says many patients enroll in studies because they think they’ll be getting extra care with a physician. "Make sure that the reality and the message are the same."
Their experience in the study also must be good, and Harper says that means making sure that there is enough staff to handle the patients. "Don’t take on more than you can realistically do," she says.
In the end, there is no magic formula, Harper points out.
"People always ask me what kind of ad design makes for the best recruitment. But that isn’t what makes something work. It’s the non-glamorous stuff like planning that will bring success. The rest is tactics and strategies. And those don’t matter if you don’t have a good plan, adequate resources, and a willingness to work hard."