The Institute of Medicine's (IOM's) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices evolved from the Forum on Drug Development, which was established in 1986. Sponsor representatives and IOM determined the importance of maintaining a neutral setting for discussions regarding long-term and politically sensitive issues justified the need to revise and enhance past efforts. The new Roundtable is intended to be a mechanism by which a broad group of experts from the public* and private sectors can be convened to conduct a dialogue and exchange information related to the development of drugs, biologics, and medical devices. Members have expertise in clinical medicine, pediatrics, clinical pharmacology, health policy, health insurance, industrial management, and product development; and they represent interests that address all facets of public policy issues.
From time to time, the Roundtable requests that a workshop be conducted for the purpose of exploring a specific topic in detail and obtaining the views of additional experts. The first workshop for the Roundtable was held on April 14 and 15, 1998, and was entitled Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making. The summary on that workshop is available from IOM.
This workshop summary covers the second workshop, which was held on May 24 and 25, 1999, and which was aimed at facilitating the development and proper use of drugs, biologics, and medical devices for infants and children. It explores the scientific underpinnings and clinical needs, as well as the regulatory, legal, and ethical issues, raised by this area of research and development.
Table of Contents
|2 Similarities and Dissimilarities in Physiology, Metabolism, and Disease States and Responses to Therapy in Children and Adults||14-33|
|3 Pharmacokinetics and Pharmacodynamics in Children Versus Adults||34-60|
|4 Extrapolation of Safety and Efficacy Data to Children||61-70|
|5 Raising Awareness of Regulatory, Legal, and Ethical Issues||71-91|
|6 Concluding Remarks||92-94|
|Appendix A: Workshop Agenda||105-110|
|Appendix B: Biographies||111-122|
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