Drugs

Measuring Growth and Evaluating Pubertal Development Guide

FDA has released a draft guidance entitled “Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials.” The document provides recommendations on the most appropriate methods for measuring and recording growth and evaluating pubertal development for evaluating safety. The agency notes that it does not address use of growth or pubertal development data to support primary evidence of efficacy in growth disorders (e.g., primary growth deficiency, disorders of pubertal development such as precocious puberty or delayed puberty).

“In general, pediatric clinical trials should include accurate, serial measurements and recordings of growth parameters if an investigational drug has the potential to affect growth or pubertal development,” it says. “Typically, growth is assessed using measurements of weight and linear growth (length and height), and when appropriate, head circumference.” Usually, it says, pubertal development is assessed using clinical phenotyping, and accurately identifying the onset and progression of puberty is necessary for the accurate interpretation of growth data.

Additionally, the guidance recommends that sponsors:

Develop a protocol for training investigators and trial site personnel responsible for collecting growth parameters and conducting physical examinations.
Avoid self-reported growth measurements because they may not be accurate, consistent, and reliable for data collection. Growth measurements obtained outside trial sites may be acceptable if the measurements are taken by a trained health care professional using appropriate and calibrated instruments.
Collect and record growth measurements for a minimum trial duration of 12 months. Sponsors should discuss alternative trial durations with the appropriate review division and consider any potential safety concerns related to the drug for the intended patient population.

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