Services help clinical trial sites and sponsors locate "lost" participants

Concerted efforts find many of the missing

The reality of clinical trial enrollment is well known to all in the clinical trial industry: it's increasingly difficult to recruit study participants. This means that the people who are recruited are exceedingly valuable, and it is particularly frustrating to lose any of them at follow-up.

"Some of CenterWatch's surveys have reported there's an average of about 25 to 30 percent of patients who drop out of a trial, and some percentage of those become lost to follow-up," says Helen E. West, director of client relations for MMG of Rockville, MD. MMG is a patient recruitment and retention firm. West has spoken at national research conferences about how to find lost research subjects.

Lost to follow-up is a coined term which means there have been repeated attempts to re-engage a patient in a clinical trial, and the site has exhausted its resources trying to bring them back in for a study visit or follow-up, West says.

The good news is that about 80 percent of the participants contacted will re-engage in the trial, West says.

As a best practice, sites should send no-show participants a certified letter that is kept on file, showing the site had due diligence in trying to engage the client in the trial, West says.

From a sponsor's perspective, there is a significant investment made in each subject, in terms of the cost of study products and the collection of data. Also, the loss of patients means there might be problems in demonstrating a product's efficacy, so additional patients have to be enrolled to make up for the loss, West notes.

Clinical research organizations increasingly are shifting focus on retention programs, but that's only part of the picture.

"What do you do when the retention program is unsuccessful and the patient disappears?" West says. "Some might engage the efforts of missing person locators, and some Internet services can be used, but that process in and of itself is not ideal."

These types of services typically are not experienced in locating research patients, and their approach might be wrong, West says.

This is where MMG and Patient Locator of Mansfield, TX, fill a void.

MMG focuses on clinical research, and is skilled at handling confidentiality and other issues pertinent to this industry, West says.

Patient Locator, which is a spin-off of Worldwide Tracers, was begun in 1999, when a major pharmaceutical corporation asked the company to consider finding patients who are lost to follow-up, says Kirk Rutherford, director of Patient Locator. Rutherford also has spoken about this topic at national research conferences.

"It was a program no one had ever entered into, and I suppose it was because of our recognition and reputation that they chose us," Rutherford says. "We went through the contracts and areas of confidentiality they wanted us to uphold, and we pretty much knew how to go through a clinical trial search without violating a patient's confidentiality, which is the most important part of our involvement."

Rutherford and West describe how they are able to locate lost participants:

1. Use a model that ensures confidentiality.

Licensed investigators who contract to search for clinical research subjects need to have a confidentiality agreement with the sponsor or CR organization, Rutherford says.

"Part of our licensing qualifications command we maintain the confidentiality of our clients, and that puts us in a better position to actually go along with what HIPAA compliance is," Rutherford explains.

When Rutherford speaks with clinical research professionals, the first question he typically is asked involves HIPAA compliance.

"Every sponsor interprets our participation in a different way," he says. "If we're a third party contractor they allow us to make the contact — others do not."

Another model is to hire a company such as MMG to serve as a conduit that passes information to the site and to the search firm, like Patient Locator, in a way that is secure and protects patient confidentiality, West says.

For example, MMG will work with sites during the enrollment process to make certain they include information on the informed consent document that has patients agreeing to be contacted by the third party if they fail to show up for visits, West explains.

"It also sets the expectation with patients that they are agreeing to make themselves available," she says. "So it can be preventative in nature."

"We work with the site and sponsor to ensure appropriate permission is gained through the informed consent process," West says. "If the site is not able to get in touch with the patient to perform the follow-up visit, then the site gives permission to a third party to assist in that effort."

When MMG receives information from the site, they pass that on to Patient Locator.

"We act as a conduit to track and manage and make sure status reports are available to the sponsor, without the patient information being disclosed to the sponsor," West says.

"We provide forms the trial site fills out and submits to us," West explains. "It's logged in and sent to Patient Locator, who performs the search."

Then MMG manages the process to make sure they know how many lost subjects remain outstanding, West adds.

2. Verify information only as permitted.

Sites provide the retention or search company, the participant's last known contact information, but they omit information about what trial the person is in and what the person's condition is, West says.

"All of this is to protect patient confidentiality and to be in compliance with HIPAA," West says.

Depending on which model a company uses, either MMG, Patient Locator, or the CR site will verify the information they've found regarding the patient's new contact information.

"MMG has the credentials that, in some cases, allow them to make contact with the patient," Rutherford says. "This process is a new thing, and some clinical trial sites and sponsors are afraid to go forward with this type of situation of locating lost-to-follow-up patients out of fear of using licensed private investigators."

When the information is found, verification involves having someone call to make certain that the correct person was located, West says.

"If we confirm the current contact information, we'll pass that information back to the site," West says. "Then the site can make attempts to re-contact the patient, or MMG can do that on behalf of the site."

When MMG is contracted to provide this follow-up contact, it can save time, as MMG can act on the updated information very quickly, West notes.

"The advantage there is that our patient contact center staff deal with patients every day and have information on how to approach them about engaging in the trial," West says.

3. Use caution when making contact with participant.

The patient contact is either by telephone or email, West says.

"First and foremost, you want to communicate to the person that the reason they're being pursued is out of concern for their health," West explains. "And you tell them that the investigator is obligated to do everything within his ability to safely follow-up with the patient as part of the person's participation in the clinical trial."

It's important to convey that the visit isn't about pestering or hounding a participant, West notes.

The person who calls the patient also explains that he or she is acting on behalf of the physician or study center, and their responsibility is to make certain the person is okay, West adds.

"We ask them to return to the trial, and if they have any issues about doing that, then we're engaging them in a discussion about the details of that situation," West says.

"We would record the response if the patient has concerns about continuing in the trial and what those reasons are, and then we notify the site so they can close out the patient's participation in the trial," West adds.

Also, MMG would not engage in any Patient Locator search for a research participant who has indicated that he or she wanted to withdraw from participating in a trial, she says.

Sometimes patients have decided to withdraw from the study, but did not feel comfortable telling CR professionals their intention, West says.

"They're more comfortable telling us that they are not able to fulfill it, and we communicate that back to the site," West says. "We tell the patient, 'I'm sure that's not a problem; would you be able to come in for a last visit so we could get your safety information.'"

Other reasons why patients become lost to follow-up include crises in their families, including illnesses, job loss, etc., West says.

"Some patients feel like there's a lack of efficacy with the study treatment, either because they suspect they're on placebo, or if they think it's not working as well as the previous treatment," West explains. "And there are folks who move and just forget to provide forwarding information, so they become disconnected with the trial."

4. Employ tools used by licensed investigators to find people.

Licensed investigators have more tools available in finding people than does the average Internet user, Rutherford says.

There are federally-approved databases like Choice Point, which has credit bureau information, such as addresses, that are available to licensed investigators and law enforcement officials, he says.

"They don't allow us to get into individuals' credit reports because that would be a violation of many laws," Rutherford notes.

But the information a licensed investigator can find includes the latest recorded contact data.

"There are a number of different things contained in databases that help us discover the most recent address and phone numbers for the patients," Rutherford says.

Finding patients lost-to-follow-up is a program Rutherford personally believes in.

There is a future for this kind of work in clinical trials, Rutherford says.

"The more patients sites can find, the better off everyone is," he adds.

Clinical trial sites that go to this degree of trouble to find lost-to-follow-up patients will benefit both from finding some of the lost trial subjects, but also from being able to show regulatory agencies how they did everything they could to find participants who had not returned for study visits and follow-up, Rutherford says.