PC2018: Tanner Staging Use in Pediatric Clinical Research

Purpose/Objectives: Rapid and complex overlapping hormonal, physical, and cognitive components occur during the transition from childhood to sexual maturity. Tanner Staging is employed in many pediatric clinical trials which do not involve investigational products intended or suspected of treating or causing pubertal disorders, predominantly to assess the childbearing potential of female participants, which may trigger requirements for pregnancy tests and contraception use. Protocols rarely call for this assessment to be conducted by clinicians properly-trained for this assessment which is the province of pediatric endocrinologists; other medical specialists may never have conducted such assessments, or may not have done so for many years. The evaluation of minors of childbearing potential involves several legal, psychological and ethical questions. In some instances, these may be better processed by an inter-professional team involving the primary care practitioner, the Principal Investigator or his collaborators, or a psychologist and a gynecologist with an experience in child and adolescent bio-psychosocial development. The presence of the caregiver or chaperon in the same room can be useful for the adolescent to feel safe. Gender and cultural differences must also be considered prior to conducting a physical examination. Gender difference, when conducting a Tanner Stage assessment, can represent a moment of intense stress and embarrassment for young patients. In some cultures, it may be uncomfortable or even shameful for a male doctor to examine a female patient and the examination of a male patient by a female can be perceived as extremely embarrassing for the young patient. In addition to obtaining consent prior to the examination a proper explanation of the reason(s) the examination is necessary and detailing the procedures of the assessment using age-appropriate terminology in a tactful manner should be employed. The authors propose that retraining or certification of staff involved in a pediatric clinical trials involving Tanner Staging should be considered to ensure that those making this assessment are fully qualified thereby minimizing variability in the assessment.
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Design/Methods: Peer reviewed journals and experience in clinical research

Results: Age is not a good predictor of this because of a mix of genetic, ethnic, nutritional, and psychosocial factors. Adequate assessment of pubertal onset and progression is crucial to detect disorders that may affect the sexual maturation process, but also an essential part of clinical trial conduct in children.

Conclusion/Discussion: Tanner Staging assessment is unlikely to be as potentially damaging to a child as a within-trial pregnancy so the point here is not to discourage or prevent Tanner Staging, but to conduct it in the most appropriate way.