Interactive
Voice Response (IVR) Technology Adds Value to Clinical Trials
FOR
IMMEDIATE RELEASE (July 12, 2002). Madison,
WI At the New Clinical Drug
Evaluation Unit (NCDEU) 42nd Annual Meeting June 10-13 2002 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).
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For
more information contact:
Keith
Wenzel, Vice President Business Development
Healthcare Technology Systems, Inc.
Phone: 608-827-2454; Fax:
608-827-2444
E-mail: kwenzel@healthtechsys.com
www.healthtechsys.com
