A new clinical trial will allow participants to receive medication, video-conference with clinicians, and report symptoms in the comfort of their own homes.
The trial, aptly named REMOTE (Research on Electronic Monitoring of Overactive bladder Treatment Experience) and sponsored by New York-based Pfizer, will evaluate Detrol LA (tolterodine tartrate), a drug that tames the muscle spasms underlying a form of urinary incontinence called overactive bladder. But the real aim is to test the ‘virtual’ trial design by comparing the results from REMOTE with a conventional postmarketing trial that has already been completed.
The technique could provide a way to cut clinical trial costs and encourage more patients to enrol in studies. If REMOTE stands up to the test, experts say other companies are likely to follow with their own virtual studies.
Patient recruitment is a major stumbling block for many clinical trials. About a third of all sites in a multi-site study fail to enrol the targeted number of subjects, says Kenneth Getz, a senior research fellow at the Tufts Center for the Study of Drug Development in Boston. About 90% of all trials are extended by at least six weeks because of failure to enrol the required number of patients on schedule.
Pfizer’s initiative could encourage trial enrolment by eliminating many of the clinic visits that can dissuade busy patients reluctant to take time away from work and family. Investigators will screen patients via computer, and aim to enrol about 600. Participants will receive their blinded study medication at home, will report their progress online, and will have round-the-clock, remote access to study physicians.
The trial design fits with an ongoing push to improve volunteer recruitment and retention by making participation in clinical trials more convenient, says Getz. For example, some home healthcare providers now conduct clinical trials in patients’ homes.
If Pfizer’s trial is successful, Getz expects the idea to catch on with other sponsors and contract research organizations, particularly for observational studies and trials that target chronic illnesses. Richard Schilsky, an oncologist at the University of Chicago, notes that the approach may also be applicable to some aspects of cancer clinical trials as well. Patients could remotely log the side-effects of their treatments, for example, and clinicians could screen for eligible patients via a website.
But the approach may do little to pull in minority communities and other special populations that are often underrepresented in clinical trials, Getz cautions: “Often these communities require a lot of hand-holding that may not be conducive to a virtual model.”
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