Rational Therapeutics for Infants and Children Workshop Summary (2000) / Chapter Skim
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6 Concluding Remarks
6 Concluding Remarks
Pages 92-94
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From page 92... ...
Careful attention must be paid to recruitment incentives, clinical trial designs, the use of placebos, and the sufficiency of the data required for use of a drug by adults before children are involved. The workshop has raised concerns about whether sufficient numbers of pediatric patients and sufficient numbers of qualified clinical researchers can be recruited to carry out the ambitious studies that workshop participants agreed were desirable.
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From page 93... ...
· Longer-term follow-up studies must be developed, financed, and conducted to assess the effect of drugs on unique pediatric safety issues such as children's growth and their neuronal, psychosocial, and endocrinologic maturation. · If it is concluded that this incentive program is effective in spurring the development and appropriate use of drugs in the pediatric population and that it is worth the overall cost to society, the question of whether it should be applied to other populations (such as pregnant women, elderly people, or members of minority groups)
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