Improve your site's subject retention, follow these specific strategies

Investigators will knock on doors

It's a maxim in business marketing that it costs four to six times as much to find new customers as it does to keep existing ones.

For clinical trial sites, subject enrollment might be even costlier, so sites should work as hard as good businesses do to keep the people they already have, an expert says.

"We run research like a stand-alone business," says Jeff Kingsley, DO, chief executive officer of Southeast Regional Research Group in Columbus, GA.

"Too many research sites treat research as a sideline," Kingsley says.

By making a business of research and treating clinical trial (CT) participants as well as a business might treat its customers, Southeast Regional Research Group has maintained a high enrollment and retention rate, exceeding industry averages, Kingsley says.

Only about 10-20% of the trials fail to meet enrollment deadlines, and patient retention is 75-90%, depending on study length, he says.

Here's how the research group keeps retention high and trial participants satisfied:

• Make follow-up a priority: "It makes no sense to lose a patient," Kingsley says.

"Our job is to provide data to the sponsor that will help them present to the FDA," he says. "If a patient doesn't stay until the end of therapy, then the data are worthless."

It's also important to keep participants enrolled from the perspective of an ethical obligation to see that they are observed for adverse events (AEs), he notes.

"There are follow-up labs that look at liver, EKGs, and to lose that patient means we don't truly know whether the patient had some AE," Kingsley explains.

So, unless a subject asks to be taken out of a study, there are strong obligations on the part of the clinical trial site to keep that person enrolled.

One common reason patients are dropped from a study is that the patient simply stops showing up because of a lack of transportation or forgetting appointments.

"If patients don't have transportation, then we pick them up," Kingsley says. "If the only time a patient can come into our office is at 6 a.m., then we're here."

When patients don't respond to phone calls, the research group sends staff to their home to knock on their doors, he adds. Investigators, including Kingsley, have made these home calls.

"Everyone in the company adopts the same philosophy," he says. "If a patient says, 'I'm done and not coming back,' then he has that right."

But patients who don't return because of transportation or similar obstacles need to be helped so that they can stay enrolled, he adds.

"We have patients who don't come in for their test of cure, which typically is the last visit for a study of pneumonia or flu," Kingsley says. "We call and call and call, and if they still don't come in, we'll drive out to their house."

The investigator or clinical trial professional will say to the patient, "We care about you and want to see you at the office," Kingsley says.

"And sure enough, that person will be in the office the next morning," he adds.

"Our retention rate is very high, depending on the indication and length of the study," Kingsley says. "Across the industry, retention is 75%, and we can beat that: On an acute study that's two weeks long, we have 90% retention."

• Make participants feel important: When clinical trial participants are treated as if they're very important and their own needs are met, then they'll both stay in the study and return to enroll in future studies.

The CT offices have water coolers, coffee, big comfortable chairs, recliners, and a flat screen wall television, Kingsley says.

"We have patients who say 'Good-bye' to the television," he says.

"If we have a patient without a car, then we send a taxi to his home and pick him up and bring him back here," Kingsley says. "If we have patients without telephones, we provide them with a prepaid cell phone for the duration of the study."

There's no reason why a study site should lose patients because of small obstacles like the lack of telephones or cars, he notes.

In fact, some patients have returned years later, and they've referred their family members and colleagues to the research site.

"We typically pay patients, tailoring the amount to how much time they spend on the trial," he says. "Our patients will self-refer and come back to us if we have another study."