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Madison, WI At the New Clinical Drug Evaluation Unit (NCDEU) 42^nd Annual Meeting June 10-13 in Boca Raton, Florida, data were presented substantiating the value of Interactive Voice Response (IVR) technology in gathering patient self-report data in clinical trials. Reports by several investigators presented new evidence that administration of psychiatric outcome measures directly to patients by way of innovative computer-based IVR programs utilizing the touchtone telephone provides data as good as, if not better than, those obtained by clinician raters. In addition, the technology offers advantages in data collection and processing that promises to reduce the cost of clinical trials and shorten the time to bring a drug to market.

A poster presentation by Jyoti Rayamakhi, PhD and colleagues from Eli Lilly and Company titled, “A Comparison Between Interactive Voice Response System and Clinician Administration of the Hamilton Depression Rating Scale,” showed patient self-ratings by IVR to be the equivalent of clinician ratings in separating the investigational drug, duloxetine, from placebo and actually more effective than clinician in separating fluoxetine from placebo.

In two workshops held on June 10 and chaired by Mark Rapaport, MD of the University of California-San Diego, additional studies underscoring the value of IVR were presented. Douglas Feltner, MD of Pfizer, Inc. compared data obtained from IVR-administered and clinician-administered versions of the Hamilton Anxiety Rating Scale (HAM-A) in a generalized anxiety disorder relapse prevention study comparing pregabalin to placebo. Since entry into the study required a clinician HAM-A score of at least 19, all participating patients met this standard. The IVR-generated scores of the very same patients, however, showed that a substantial number rated themselves lower than the entry score of > 19, raising issues that cut to the very heart of patient recruitment for clinical trials (see slide below).

An even more striking finding in this study was that the drug/placebo difference in preventing relapse was more than twice as great using IVR-generated patient self-report HAM-A scores than clinician administered assessments (29% versus 14%). This finding of a more robust drug/placebo separation based on IVR rating suggests that studies could be brought to successful completion more rapidly and with fewer subjects using this technology.

A workshop presentation by Anita Clayton, MD, University of Virginia, demonstrated the value of IVR in assessing antidepressant-induced sexual dysfunction. The IVR version of the questionnaire she developed, Changes in Sexual Functioning Questionnaire (CSFQ), was administered by telephone to subjects at home on days 0, 2, 4, 6, 8, 15 and 21. Outpatient visits were made on days 0, 8, 15, and 21. IVR showed significant sexual dysfunction occurring as early as day 4, a finding that would have been delayed to day 8 had outpatient visits been the determining factor. The ease of administration by IVR (anywhere a touchtone phone is available) allows a frequency of evaluation that could not be approximated by the more cumbersome scheduling of outpatient visits. IVR assessment can be used not only to demonstrate the earliest onset of drug side effects but also the earliest onset of benefit. The fact that all IVR data are computer generated means that results are immediately available for analysis following the completion of a study.

Kenneth A. Kobak, PhD, research consultant to Healthcare Technology Systems, presented a poster, “Validation of a Computer Administered Version of the Liebowitz Social Anxiety Scale Administered by Telephone via Interactive Voice Response (IVR),” in which he demonstrated an almost perfect correlation between IVR and clinician generated total scores (0.97, p<.001). Internal consistency reliability (alpha) was 0.98 for IVR and 0.97 for clinician. Overall, 40% of subjects preferred IVR and 44% had no preference but among those with social anxiety disorder, 50% preferred IVR. The Liebowitz Social Anxiety Scale (LSAS) is the gold standard for monitoring change in social anxiety disorder clinical trials.

All of the clinical IVR systems discussed above were created, developed, and delivered by Healthcare Technology systems, Inc. (HTS), a Madison, Wisconsin based research and technology firm led by three physicians, John H. Greist, MD, James W. Jefferson, MD and David J. Katzelnick, MD. HTS is the world leader in creating, developing and implementing clinical IVR systems to gather data directly from patients. HTS currently offers more than 30 IVR rating scales, and has the research and clinical expertise to create others. The following are some of the more commonly used scales that have been adapted to IVR administration: Hamilton Depression Rating Scale (HAM-D), Hamilton Anxiety Rating Scale (HAM-A), Liebowitz Social Anxiety Scale (LSAS), Mental Health Screener® (MHS), McGill Pain Questionnaire, and Changes in Sexual Functioning Questionnaire (CSFQ).