Think of recruitment in marketing terms

Define plan, build solution, track results

Clinical trial sponsors need to build a business plan for their subject recruitment process, and it should include strategies for building a solution and tracking results, an expert says.

Recruiting research participants can be compared with how a new fast food burger restaurant finds customers, says Cosimo Spera, PhD, head of predictive analytics for DecisionView in San Francisco, CA.

"When a company like McDonald's plans a new operation, they estimate the arrival range of customers," Spera says.

The company also determines the prime business time frame, perhaps around 12 noon, and determines how many burgers to defrost, staff to have at the cash register, and fries to prepare, Spera adds.

"When we're trying to model patient recruitment for a clinical trial, we need to follow some sort of probability distribution," he explains. "Not everybody in a clinical trial will go to a medical center at the same time to be screened."

Also, each clinical trial has a geographical area from which potential participants can be recruited, and this varies across diseases and regions, Spera says.

"The ways these patients are arriving follows a probability distribution, and so mathematics comes into it," he says. "By using mathematical techniques, we are able to predict when a trial is going to finish its recruitment, and we can provide accurate information for people who have to make decisions on how to run the trial."

Anticipate deviations

The challenge is for clinical research sponsors to understand and anticipate deviations in the recruitment plan.

"In order to put some of the best practice processes together, one of the first things a company that does clinical trials should do is build a solution with a plan definition and to track the plan," Spera suggests. "They need to quickly understand the execution of the trial and to immediately decide which are the best actions to take to correct problems."

Tracking is essential because it gives a sponsor the information necessary to make recruitment strategy changes when these are necessary.

For example, suppose a CR site has targeted 100 patients for enrollment, and the goal is to recruit 10 new patients each week, Spera says.

But the site's actual recruitment falls short, and on average five new patients are recruited each week. This means it will take twice as long — 20 weeks instead of 10 weeks — for the site to complete its enrollment, he explains.

"I use that information to make an update on my plan and say, 'I expect to finish the recruitment by this day,' and if that's not acceptable, then I can use that information to make recruitment corrections," Spera says. "I can run an advertising campaign in the center's area."

Another potential problem that should be dealt with through monitoring and plan adjustments includes the discovery that the subject screening failure rate is higher than predicted.

"When you have a high screen failure rate, one possibility is the process you have put into place for screening might not be correct," Spera says.

Sponsors and CR sites need to make certain the screening process is being done correctly. And if they are confident that everything is being done precisely as intended, then the sponsor might need to request modifications to the study protocol, Spera suggests.

Logistics also can create study recruitment problems.

A CR site might be recruiting at a brisk pace and then find that there isn't enough investigational product available to handle all of the site's study participants. This could result in people dropping out of the trial, which could lead to costly delays.

"So you need to talk with the sponsor and arrange for a replenishment of the drug," Spera says.

For instance, the sponsor could have a site that's been slow in recruiting participants send over some extra product, he adds.