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Issues and Challenges in the Design and Conduct of Clinical Trials of Drugs in Pre-Term Infants and Neonates

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The National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH), Department of Health and Human Services, will sponsor a working meeting to explore approaches for the design and conduct of clinical trials to foster safe and effective drug therapies in pre-term infants and neonates on March 29-March 30, 2004, at the Baltimore and Washington International Airport Marriott Hotel.

The NICHD is sponsoring the meeting in collaboration with the Food and Drug Administration, the Fogarty International Center, and other NIH institutes and centers, including the National Cancer Institute; National Heart, Lung, and Blood Institute; National Institute of Dental and Craniofacial Research; National Institute of Diabetes ands Digestive and Kidney Diseases; National Institute of Neurological Disorders and Stroke; National Institute of Allergy and Infectious Diseases; National Institute of General Medical Sciences; National Eye Institute; National Institute of Environmental Health Sciences; National Institute of Arthritis and Musculoskeletal and Skin Diseases; National Institute of Mental Health; National Institute on Drug Abuse; National Institute on Alcohol Abuse and Alcoholism; National Institute of Nursing Research; National Human Start Printed Page 54909Genome Research Institute; National Center for Research Resources; and National Center for Complementary and Alternative Medicine.

The purpose of the working meeting is to discuss the current status of drug research in neonates and pre-term infants. The meeting will focus on exploring gaps in existing knowledge in this field and in developing strategies to rectify the gaps that could be implemented by federal agencies and the scientific community.

Participants at the meeting will develop recommendations for potential research approaches for current and future pharmaceutical agents for use in newborns. The focus will be on issues related to: Trial design, ethics, pharmacokinetics, pharmacodynamics, efficacy and toxicity, drug formulations, drug prioritization, and surveillance of adverse events. Additional discussion will consider the assessment of long term outcomes and issues related to research in small subpopulations.

Attendance at the meeting will be limited. Persons interested in attending the meeting should submit a request containing the following information to <>.






Persons interested in obtaining more information about the meeting may contact Dr. Donald Mattison, NICHD, 6100 Executive Boulevard, Room 4B-100, Rockville, MD 20892, e-mail <>, telephone 301-496-5097 (not a toll-free number).

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Dated: September 12, 2003.

Raynard Kington,

Deputy Director, National Institutes of Health.

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[FR Doc. 03-23904 Filed 9-18-03; 8:45 am]