Summary remarks
Article Abstract:
Considerations in the design of clinical trials involving a patient or a group of patients with wasting conditions depend on the objectives of the studies. Definitive therapeutic trials are conducted primarily to assess the efficacy and safety of pharmaceutical drugs. It is important to be clear about the exact indication for which an agent is assessed. Usually, the endpoints are selected by exactly how the indication is defined. A well-defined indication is very important for choosing a meaningful and objective primary endpoint. The evaluation of clinical outcomes is also discussed.
Publication Name: The Journal of Nutrition
Subject: Food/cooking/nutrition
ISSN: 0022-3166
Year: 1999
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Working group session report: special considerations in trials involving children
Article Abstract:
Clinical trials of agents for the treatment of wasting in children need special consideration of data in terms of physical growth and development. Clinical researchers should take advantage of the opportunities offered by trials involving children because growth and development are powerful markers of treatment efficacy. However, data from clinical trials with children as subjects must be interpreted based on normative data, including data standardized for chronologic age, bone age, gender, race and stage of sexual development.
Publication Name: The Journal of Nutrition
Subject: Food/cooking/nutrition
ISSN: 0022-3166
Year: 1999
User Contributions:
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