Forecast and plan to improve recruitment
Forecast and plan to improve recruitment
Advertising isn’t everything
The first step to improving clinical trial subject recruitment is to think of recruitment as more than advertising, an expert says.
"It’s actually a very complex process of forecasting and planning that requires you to have to really understand each patient population’s specific dynamics and nuances," says Elizabeth Moench, president of the MediciGroup Inc. of King of Prussia, PA. She spoke about patient recruitment and retention at the 41st Annual Meeting of the Drug Information Association, held June 26-30 in Washington, DC.
For example, if a clinical trials site is trying to find patients for an oncology end point study, then the issues of concern are completely different than if the study involves patients with knee pain, Moench says.
"We do extensive formatting and forecasting, and this determines which strategies we put in place," she says.
Some of the factors that need to be considered include the prevalence rate of the condition and the media response predicted for each type of condition, Moench explains.
"For instance, we may be heavily focused on different Internet initiatives for a hard-to-find cancer population, and that might be quite different from what we do to find emphysema patients," she says. "The higher the prevalence rate, the more opportunities there are to use mainstream media."
Studies involving diseases with low prevalence rates will have to target specific initiatives and Internet specialty populations, Moench notes.
Another key to recruitment success is to get into the patient’s mindset, she says.
"If you had this condition, where would you go for information? Where would the information be, and how do you go about finding it?" Moench says. "If we use the Internet, there will be multiple words and phrases you would put into play in order to search for that information."
A clinical trial site could advertise its study on the Internet by using a search engine to place information about the study in places where potential subjects might find it, she points out.
"You have to translate the symptoms into lay language which is using these clues to find patients," Moench notes.
The same strategy can be used to make a study’s own web site jump to the first or second on the search engine’s list when those symptoms are keyed in by a potential research participant, she adds.
When the newspaper is used, innovation is required, Moench says.
"We have unique ways of using the newspaper, and that’s where we’ve pioneered some fringe advertising methods," she says.
However, it’s important to keep in mind that not one method will achieve the recruitment goals, so it’s important to have an integrated approach, Moench advises.
"Especially in today’s environment, where there’s so much noise, getting through the cluster requires different strategies," she says. "You need to collect real-time metrics to determine which recruitment method is the most effective."
Using data about recruitment successes and failures also requires clinical trial sites to maintain flexibility and to continually shift where they put their resources as they see which strategies are bringing in most of the patients for the least amount of money, Moench adds.
One big mistake sponsors often make is setting themselves up for failure by not providing enough money for recruitment, she says.
"They’ll provide, say $5,000 a site; but if you have a site in Chicago and one in Birmingham, your ad and recruitment costs are going to be significantly different," Moench continues. "Chicago is going to be significantly more expensive, so one size does not fit all."
When sponsors expect the budget to average out across various sites, they are setting up some to fail, she says.
"The second error is they don’t know which sites are performing and which are not until the study starts," Moench says. "So they should encourage sites to recruit from their own database, giving them four to six weeks for this."
This way if a site has no activity at all, then it is a nonproductive site and probably isn’t worth the investment, she adds.
"The chances are they will do nothing as the study continues, so you should recruit those who demonstrated interest in your study," Moench says.
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