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(November, 2004) - The U. S. Food and Drug Administration (FDA) has recently issued a statement regarding the acceptability of Interactive Voice Response (IVR) self-report instruments that assess severity of illness in Major Depressive Disorder and stated that these instruments are acceptable as primary endpoint data in pivotal clinical trials. The assessments mentioned include the Hamilton Depression Rating Scale (HAMD), the Inventory of Depressive Symptomatology (IDS) and the Quick Inventory of Depressive Symptomatology (QIDS).

The notification was issued in a letter to Dr John Greist, CEO of Healthcare Technology Systems (HTS), the world authority in the research, development and validation of computer administered clinical rating instruments. Previously HTS had submitted evidence to the FDA on the effectiveness, validity and advantages of self-report assessments. HTS assessments for all pharmaceutical sponsored Phase I-IV trials are now delivered exclusively by ClinPhone, the global leader in clinical trial management solutions.

Although the FDA's comments regarding IVR are aimed primarily at research on depression, the statement promises to have far-reaching consequences in the clinical trials industry. Already, the FDA has accepted IVR assessments for migraine, sleep, pain, social phobia and other disorders, and the list is expected to grow. Pharmaceutical sponsors will now be able to choose IVR with the assurance that it has backing from the FDA. This means that both pharmaceutical companies and their patients will be able to reap the benefits that IVR assessments deliver.

Implementing IVR offers several advantages over traditional methods. In the past, patients were assessed by clinical interviewers, but the evidence suggests that there is substantial variability in assessments conducted by clinicians. Further, studies have shown that interviewers may artificially inflate or deflate baseline scores to qualify patients for inclusion in a trial. Using IVR, assessments are standardized and all questions are asked and scored consistently. Additionally, IVR assessments perform error checking during interviews and offer immediate data storage and reduced costs. Finally, patients can call into these automated systems as often as required by the protocol, even doing so from home.

Dr Greist commented, "This communication from FDA extends the use of the IVR HAMD beyond its widely recognized value in controlling rater score inflation at baseline to assessment over time where rater variability may adversely affect trial outcome. Further, accumulated evidence has shown that patient self-reports are accurate and regulators recognize the importance of the patient's perspective in evaluating drug efficacy."