lescence is clearly a period of physical and psychosocial maturation and vulnerability related to hormonal changes, changes in appearance, and transition toward adult roles and responsibilities. The metabolic and other effects of hormonal changes associated with puberty may alter disease processes (e.g., in patients with diabetes) or contribute to the onset of medical problems (e.g., depression or polycystic ovary syndrome), with corresponding implications for disease prevention, diagnosis, and management (see, e.g., Janner et al., 1994; Travers et al., 1995; Angold et al., 1999; NRC/ IOM, 1999; Schultz et al., 1999; Driscoll, 2003; and Sarnblad et al., 2003). Changes associated with puberty are an important consideration in much drug research, and the combination of physical, emotional, and social changes makes adolescence a particularly challenging period for psychosocial research.

In its regulations on pediatric drug testing, FDA uses a narrow definition of adolescence—ages 12 to 15 years (“up to 16 years”) (FDA, 1994a; 21 CFR 201.57(f)(9)(i)). The ICH guidelines, however, refer to adolescents as those aged 12 to 16 or 18 years (with the observation that the upper limit “varies among regions”) (ICH, 2000b, p.10). When adolescents are included in studies that also include adults, the guidelines suggest that it may appropriate “to consider studying adolescent patients … in centers knowledgeable and skilled in the care of this special population” (ICH, 2000b, p. 10). Recently, in draft guidance on the testing of medical devices, FDA proposed a broader age for adolescents—12 to 21 years—citing “the impact that a device could have on a growing adolescent as well as the effect growth could have on the device” as a rationale for the upper age limit (FDA, 2003b, p. 3). The agency noted that other factors—including weight, physiological development, and neuromuscular coordination—may be more relevant than chronological age for the assessment of device safety and effectiveness.

The Nelson Textbook of Pediatrics describes three periods of adolescence: early (ages 10 to 13 years), middle (ages 14 to 16 years), and late (ages 17 to 20 years and beyond) (Behrman et al., 2004).5 The text observes that the first visible signs of puberty usually occur between the ages of 8 and 13 years and thus the period of early adolescence overlaps with the period of middle and late childhood. In a general statement on the age limits for pediatrics practice, the American Academy of Pediatrics (AAP)

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Some of those involved with adolescent health services identify the transition period to adulthood as extending into the third decade of life (see, e.g., SAM, 1995). The spectrum of pediatric or adolescent care may also be stretched to cover the situation of children with conditions such as congenital heart disease or cystic fibrosis who survive into adulthood but who continue to benefit from care and support provided by their pediatric care team.



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