January 24, 2023: A new report finds that 3,627 American children participated in clinical trials whose results remain hidden. This is not ‘only’ unethical – it’s illegal.
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NCHR Comments on FDA Ethical Considerations for Clinical Investigations of Medical Products Involving Children
December 27, 2022: We address suggestions of how to improve this guidance to promote safety and efficacy in clinical investigations of medical products involving children. Many new medical products that are used by children are never actually tested on them or approved for them prior to entering the market. Many children are either left with no treatment options or given products “off label” that have not been tested for safety, effectiveness, or dosage requirements in patients of their age, size, or weight.
Read More »NCHR’s Public Comments on United States Preventive Services Task Force’s Draft Research Plan on Screening for Depression, Anxiety, and Suicide Risk in Children and Adolescents
We agree that it is very important to examine whether screening programs for depression, anxiety, and increased risk of suicide accurately identify children and adolescents with those conditions, as well as whether screening leads to improved health outcomes among children and adolescents. We agree that it is equally important to assess the potential harms of screening and treatment. There are, however, three points that we suggest should be re-examined in the draft research plan.
Read More »NCHR’s Comments on USPSTF’s Draft Recommendation Statement Regarding Screening for High Blood Pressure in Children and Adolescents
We agree that screening should not be recommended without sufficient evidence that it helps prevent negative health outcomes.
Read More »NCHR Testimony on Singulair and Neuropsychiatric Side Effects
September 27, 2019. Singulair has serious side effects and we need much better data to determine the likely benefit and risk of harm for patients. FDA has an important role to play in encouraging this research. In the meantime, patients, parents, and clinicians must be given clear information about the risks so that they can make an informed decision about whether to use montelukast (Singulair).
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