In the clinical trials industry, P.I. stands for principal investigator. But for MediciGlobal’s new subsidiary L2FU, it could also stand for “private investigator,” since its mission is to track down patients lost to follow up (commonly shortened to “L2FU”).
Traditionally, when subjects have gone missing before the end of a study, sites have had to launch into private investigator mode, scrambling to look for them using 411, searching Internet databases and calling contacts the patients listed. If those avenues yielded nothing, they would often hire an actual private investigator. But that has its limitations.
“The P.I. firms will find a name and address and say, ‘Here you go.’ Then the site staff would have to play phone tag with the patient. We knew we had to integrate more services into this process that were exclusive to clinical trials,” said Liz Moench, founder and president of recruiting firm MediciGlobal, which recently spawned L2FU with this in mind.
L2FU’s focus is tracking down patients who either have disappeared before the end of a study—20% to 60% go missing, said Moench—or have moved on after a study wraps up but must be contacted after the FDA examines the data and dictates that more study-subject input is needed. L2FU staff, whom Moench says are well versed in HIPAA and safe-harbor guidelines, track down the patients, make contact and generate secure patient-reported outcomes.
“We step in where the site would have to make the content and document it,” she explained. “It’s all very tailored to a specific study protocol, patient population and endpoint goals.”
Moench said the current climate at the FDA gave her the idea. “We saw many news reports about companies missing their primary endpoints, and in this drug risk-averse environment in which the FDA is operating there’s a lot of focus on saying, ‘Don’t give us data that’s incomplete,’” she said. That, combined with the increase in post-marketing surveillance, told her there was a need.
In contrast to working with a P.I. firm, which the site would have to call for updates on which patients have and have not been found, L2FU has a portal that allows clients to log in for real-time updates on tracking and follow up. Sites can look up patients in the portal by name; sponsors—which aren’t allowed access to patients’ identities—can track them by patient number.
Moench says L2FU recently took only one month to track down and contact about 30 patients who were three to five years disconnected from a particular study. How? Moench won’t say; it’s proprietary, of course, but it involves “billions of data” in a series of networked databases that L2FU has licensed. Some of the databases are the same ones the government and many legal firms use to find people. The data is highly private; L2FU could lose its access to it if its “trained data miners” mishandled the information, she added.
As far as she knows, L2FU is the only business of its kind focused entirely on the clinical research space. Though the service is generally used as a rescue measure, Moench says companies are starting to employ it prophylactically, to prevent huge numbers of missing patients at the end of a study. For that purpose, L2FU offers a program that takes over the
task of staying in touch with a patient throughout the study process and for years after, so that a loss-to-follow-up situation can be avoided completely.
But there are limitations, said Moench. Such deep searches work well in certain countries but not in others. “There are countries in which it becomes very difficult to get this data,” she said. “We’ve also learned that in countries where there’s a dictatorship or military rule, people fear giving the data.”
As sponsors and CROs take more clinical trials overseas, this could limit business for L2FU. But so far business is doing well, said Moench, with four clients—three sponsors and one CRO.