CBER Issues Guidance on Toxicity Grading Scales for Healthy Adults

The FDA's Center for Biologics Evaluation and Research (CBER) has released a draft guidance on toxicity grading scales for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials.

Standardized toxicity assessment scales are widely used to evaluate products designed to treat specific diseases. For example, the National Cancer Institute's Common Toxicity Criteria Scale and the Division of AIDS' Toxicity Grading Scale standardized the evaluation of adverse events among cancer patients and HIV/AIDS patients. The defined toxicity parameters of these scales are designed for patients who may already be experiencing mild, moderate or severe adverse clinical or laboratory events due to the progression of their respective diseases, and thus may be inappropriate for healthy volunteers, according to CBER.

In developing toxicity grading scales for healthy volunteers, CBER chose parameter limit values based on published information when such values were available. For example, the Brighton Collaboration has developed case definitions and guidelines to evaluate some adverse events associated with administering vaccines.

According to CBER, using a scale to categorize adverse events observed during a clinical trial may assist clinicians in further monitoring patient safety and completing required reports. However, CBER said it believes the categorization or grading of data as outlined in the guidance document is supplementary, and as such should not replace full and complete data analysis.

To view the draft guidance, go to http://www.fda.gov/cber/gdlns/toxvac.pdf (http://www.fda.gov/cber/gdlns/toxvac.pdf).