• Goldstein, Burton J. (PI)

Project: Research project

Project Details


The proposed research will provide scientific data about the reliability,
validity and characteristics of use of a newly developed technique for
rating adverse drug reactions: the Systematic Assessment for Treatment
Emergent Events (SAFTEE). Each of two levels of elicitation of adverse
events available for use with SAFTEE will be evaluated. Both levels will
be assessed in comparison to each other as well as to standard side effect
rating scales being used in ongoing Phase II and III clinical
psychopharmacology trials. This will enable an evaluation of SAFTEE under
a variety of conditions of use including populations differing on
diagnosis, use of raters of different disciplines, and a wide sampling of
psychotropic agents. The measurement of the adverse effects of drug treatment has received
little methodologic consideration in clinical trials of psychotropic
drugs. Improvement in the sensitivity, reliability and validity of the
measurement of adverse drug reactions (ADRs) will provide greater
protection for patients from toxic compounds, provide comparison data on
the side effects of psychotropic drugs to facilitate their clinical use,
and improve the quality of clinical trials across multicenter trials. Procedures will be developed to train the various members of our research
team in the use of SAFTEE and investigate whether multiple-rater agreement
can be obtained on the actual occurrances of ADRs. The use of SAFTEE will
then be added to the assessment procedures in a wide range of clinical
trials and the inter-rater reliability of SAFTEE will be measured. The
validity of SAFTEE will be determined by (1) measuring its ability to
distinguish active drug from placebo, (2) evaluating dose-response
relationships found in the various clinical trials, (3) its abilitiy to
differentiate the side effect profiles of different classes of drugs, and
(4) comparing the results of SAFTEE with those obtained with other side
effect assessment instruments.
Effective start/end date2/1/841/31/88


  • National Institutes of Health


  • Medicine(all)


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