By Deb Borfitz
February 2, 2009 | When it comes to suicidality monitoring in clinical trials, electronic patient reported outcomes (ePRO) tools have distinct advantages over both face-to-face and paper-based data collection methods, according to Michael Federico, VP ePRO solutions for Philadelphia, Penn.-based ERT.
For starters, ePRO offers confidentiality since information is collected directly from patients without the involvement of another human being. It’s also more convenient than the alternatives. “No matter how broad the monitoring scope needs to be, an ePRO solution is easy to add at any time,” says Federico. It can be as simple as adding the appropriate questions to those patients are already answering by telephone or computer. The cost of training investigative site staff is eliminated. Further, suicidality monitoring is conducted uniformly “within a trial and across many trials.”
The ePRO solutions in ERT’s arsenal also surpass other data collection approaches because they’re backed by a response system that assures swift reaction to suicide concerns, says Federico. Certain patient-reported answers, as dictated by the study’s sponsor, trigger alerts to the trial site by a pair of call centers until the responsible investigator is reached. “Before the patient is even finished with the questionnaire, we’re already calling the site.”
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| Michael Federico |
Computer-aided suicidality monitoring has been going on for more than 25 years now, though the topic has been of growing interest due to connections drawn between psychotropic drugs and suicidal thoughts in children and adolescents, says Federico. From a regulatory standpoint, it has “yet to be determined” if such monitoring will ultimately be required for any compound that crosses the blood-brain barrier or only those acting specifically on the central nervous system.
The chief challenge is accurately identifying the risk for suicide, says Federico. “Even for clinical findings, like QT prolongation [an electrocardiographic abnormality], risk took years to define.” Trial sponsors will require customized ePRO solutions for suicidality monitoring based on their interpretation of guidance documents that may be issued by the Food and Drug Administration (FDA), says Federico. Even the FDA’s 27-page guidance on QT monitoring gets differentially interpreted company to company and compound to compound.
The FDA currently requires that all psychiatry products, in every phase of development, have prospective assessment for suicidality using an acceptable instrument, according to Tom Laughren, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation & Research (CDER). At least some of those instruments can be administered via ePRO. “This policy is in effect now and will be communicated on a protocol-by-protocol basis, but may be the subject of a future position paper… [or] guidance document.”
In other therapeutic areas, there is no requirement for suicidality monitoring. The FDA “will ask for these analyses…on a case-by-case basis,” says John Jenkins, director of CDER’s Office of New Drugs.
Precisely how investigators should respond clinically to a suicide alert remains an open question. Says Federico: “Sponsors will need to outline support for their sites, especially in studies where mental health professionals are not available at the sites.”