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Newborn Drug Development Initiative Workshop

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Workshop Description



Issues and Challenges in the Design and Conduct of Clinical Trials of Drugs for Preterm Infants and Neonates

March 29-30, 2004

Marriott Waterfront Hotel
Baltimore, Maryland

The Best Pharmaceuticals for Children Act (BPCA) was signed on January 4, 2002, to establish a process for studying on-patent and off-patent drugs for use in pediatric populations, and to improve pediatric therapeutics through collaboration on scientific investigation, clinical study design, weight of evidence, and ethical and labeling issues.

As part of the BPCA collaboration, the NICHD and the U.S. Food and Drug Administration started a Newborn Drug Development Initiative to foster the development of safe and effective drug therapies for preterm and neonatal populations.

This workshop is the first in a series of such meetings for the Newborn Drug Initiative that will help frame the state-of-the-art and define research priorities for pain control and for cardiac, pulmonary, neurologic, and pulmonary diseases and/or conditions.

At this workshop, speakers and participants will:
  • Identify basic, pharmacologic, and clinical research needs to enhance the safe and effective use of drugs in preterm infants and neonates;
  • Explore approaches to the design and conduct of clinical trials of drugs in these populations, including:
  • Identifying gaps and barriers to accomplishing trials in these populations, such as ethical issues that arise in this research setting;
  • Overcoming the challenges of conducting clinical trials in limited (small) populations;
  • Exploring the challenges and approaches to designing and implementing longer term outcome trials; and
  • Addressing issues related to the selection and prioritization of drugs to be studied in clinical trials;
  • Provide comments on draft clinical trial issues that address drug development in the areas of pain control, heart failure, apnea, bronchopulmonary dysplasia, neonatal seizures and brain injury, and drug prioritization; and
  • Develop a workshop summary to disseminate the findings.


The workshop will be held at:

Marriott Waterfront Hotel
700 Aliceanna Street
Baltimore, MD 21202
Phone: 410-385-3000

For more information on the hotel, including driving directions, visit the hotel Web site: External Web Site Policy.


To learn more about the workshop or its content, contact Jan Leahey, NICHD, at 301-496-6593, or Donald Mattison, NICHD, at 301-497-5097.

To learn more about registration and logistics for the workshop, e-mail your contact information and questions to

Last Reviewed: 11/30/2012
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