The National Cooperative Growth Study (NCGS) grew out of a Food and Drug Administration mandate in 1985 that at least 300 patients treated with methionyl growth hormone (GH) be tracked for 5 years for determining the safety and effectiveness of this treatment in children. It soon became apparent that this postmarketing study would also provide pediatric endocrinologists with the opportunity to analyze long-term data on the effects of GH therapy. Therefore, the NCGS was opened to any collaborating physician in the United States and, later, North America. By the late 1980s more than 2000 patients had been enrolled. And now after 13 years the number of patients enrolled in the NCGS has exceeded 33 000, accounting for more than 107 000 patient-years of data.
Although there are limitations to analyses of retrospective data, the sheer size of the cohort provides a statistical advantage, offering an unprecedented opportunity for comparing groups in which differences might be small. In 1996 the NCGS began to collect data on children who had been referred for short stature and were not treated with GH, to have a comparison group. Inquiries into the NCGS have provided descriptions of the types of patients enrolled, analyses of treatment efficacy (often for a particular group of patients), and safety issues in GH therapy. During the past year such inquiries have resulted in several publications, including a review of 9 years' worth of data in the NCGS,1 an analysis of the value of GH therapy for overcoming the growth suppression associated with glucocorticoid administration,2 and a look at the relation of bone age maturation to growth during GH therapy.3
Each year data in the NCGS are analyzed for addressing specific questions, and the results of these inquiries are presented at the annual NCGS Investigators Meeting. This meeting provides an opportunity for discussion by those physicians who have supplied the data that are analyzed. This supplement contains the reports from the most recent NCGS Investigators Meeting, held in New Orleans, Louisiana, on October 9–10, 1998. The first session focused on the cessation of therapy for growth by addressing the issue of adult height. This discussion was followed by a session on the recent issue of GH therapy for patients with adult GH deficiency. The safety issues discussed included an analysis of the relation between GH therapy and pigmented nevi and between GH and craniofacial changes. Another session included a description of a new GH assay and an analysis of serum GH levels in regard to the diagnosis of GH deficiency. The meeting ended with a session on the usefulness of bone age determinations in GH therapy.
Because of its size and scope the NCGS will continue to be an invaluable resource for collecting data on the safety and effectiveness of GH therapy, for examining the means by which appropriate patients may be identified, and for helping establish reasonable expectations for the physicians who treat them.
- Copyright © 1999 American Academy of Pediatrics