FDA Issues New Safeguards for Children in Clinical Trials

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Oncology NEWS InternationalOncology NEWS International Vol 10 No 7
Volume 10
Issue 7

ROCKVILLE, Md-To comply with a mandate in the Children’s Health Act of 2000, the FDA has issued an interim rule implementing additional requirements to safeguard children enrolled in clinical trials. "A key aspect of the new rule sets standards and procedures for assuring that children have assented to participating in clinical trials (when possible), and that their parents or guardians are able to give fully informed consent to the child’s participation in a study," the agency said in a statement.

ROCKVILLE, Md—To comply with a mandate in the Children’s Health Act of 2000, the FDA has issued an interim rule implementing additional requirements to safeguard children enrolled in clinical trials. "A key aspect of the new rule sets standards and procedures for assuring that children have assented to participating in clinical trials (when possible), and that their parents or guardians are able to give fully informed consent to the child’s participation in a study," the agency said in a statement.

Articles in this issue
NCI to Expand Its Support for Trials of STI-571
Patients and Physicians Differ on Chemotherapy Expectations
Neoadjuvant Weekly Paclitaxel Ups Breast Cancer Pathologic Complete Response Rates
Concurrent Chemoradiotherapy Helps Preserve Larynx
Once-Daily, Rapid-Onset Morphine Offers Alternative for Those in Severe Pain
FDA Issues New Safeguards for Children in Clinical Trials
Decision Board Helps Breast Cancer Patients Assess Chemotherapy Options, Increases Satisfaction
Over 20% of Breast Cancer Patients Risk Recurrence by Not Taking Their Tamoxifen
Selective Serotonin Reuptake Inhibitors Can Successfully Treat Depression But Not Fatigue in Cancer Patients
Leukemia Society Offers Patient Information on Use of STI-571
Hiking Cigarette Prices Discourages Teens From Taking Up the Habit
Consensus Growing for SV40 Role in Some Mesotheliomas
NCI Launches Randomized Trial of Shark Cartilage in NSCLC
Chemotherapy Common at End of Life
Can Cognitive Dysfunction in Breast Cancer Patients Be Prevented?

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