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.

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.

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.

"Neonatal and Pediatric Pharmacology offers guidelines for safe, effective, and rational drug therapy in newborns, children and adolescents. The book provides relevant and useful data on the molecular, physiologic, biochemical, and pharmacologic mechanisms of drug action and therapy in this population. The authors identify areas of innovative basic and translational research necessary for the continuing evaluation and development of drugs for the fetus, newborns, children and adolescents. Neonatal and Pediatric Pharmacology is is a valuable reference for all health care professionals who treat the fetus, newborns, children, and adolescents, including neonatologists, nurses, pediatricians, general practitioners, students, obstetricians, perinatologists, surgeons and allied health professionals. It will be useful anytime during the day and especially in the middle of the night when knowledge of appropriate indications, safe and effective use, dosage, and therapeutic regimen for a certain drug or molecular entity is immediately needed. The book is also directed to those involved in basic, clinical, and other academic pharmacological research, the pharmaceutical industry, and regulatory agencies dealing with drug and therapeutic developments for this population. Those teaching pharmacology and therapeutics will find this compilation of information extremely useful in preparing teaching materials"--Provided by publisher.

As our nation enters a new era of medical science that offers the real prospect of personalized health care, we will be confronted by an increasingly complex array of health care options and decisions. The Learning Healthcare System considers how health care is structured to develop and to apply evidence-from health profession training and infrastructure development to advances in research methodology, patient engagement, payment schemes, and measurement-and highlights opportunities for the creation of a sustainable learning health care system that gets the right care to people when they need it and then captures the results for improvement. This book will be of primary interest to hospital and insurance industry administrators, health care providers, those who train and educate health workers, researchers, and policymakers. The Learning Healthcare System is the first in a series that will focus on issues important to improving the development and application of evidence in health care decision making. The Roundtable on Evidence-Based Medicine serves as a neutral venue for cooperative work among key stakeholders on several dimensions: to help transform the availability and use of the best evidence for the collaborative health care choices of each patient and provider; to drive the process of discovery as a natural outgrowth of patient care; and, ultimately, to ensure innovation, quality, safety, and value in health care.

The premier comprehensive textbook in the field, Yaffe and Aranda’s Neonatal and Pediatric Pharmacology, Fifth Edition, provides an authoritative overview of all aspects of drug therapy in newborns, children, and adolescents. It offers evidence-based guidelines for safe, effective, and rational drug therapy, including specific recommendations for all major drug classes and diseases. Now in a vibrant two-color format, this fully revised reference is an indispensable resource for pediatricians, neonatologists, pediatric residents, and fellows in different pediatric subspecialties, including neonatal medicine and pediatric critical care.

In 1992 world leaders met at the Earth Summit in Rio de Janeiro to reaffirm the Declaration of the United Nations Conference on the Human Environment that was established on June 16, 1972 in Stockholm. The meeting resulted in the adoption of Agenda 21 by the member states which is a framework for the transition to a more sustainable world. In 2012 the members gathered to assess and reaffirm the importance of progress towards the efforts of Agenda 21. In response to this the Institute of Medicine's (IOM's) Roundtable on Environmental Health Sciences, Research, and Medicine held a workshop to inform the policies that are discussed at the 2012 Earth Summit. The workshop, held in Woods Hole, Massachusetts on July 25-26, 2011, focused on the issue of sustainability and health as well as the linkages that are currently present between the two. The workshop included presentations and discussions which are summarized in Public Health Linkages with Sustainability: Workshop Summary. The report presents how different areas of public health, such as food and water resources, link to sustainability and opportunities or venues that can be examined.

In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

Widely considered the leading book involving nutrition and feeding infants and children, this revised edition offers practical advice that takes into account the most recent research into such topics as: emotional, cultural, and genetic aspects of eating; proper diet during pregnancy; breast-feeding versus; bottle-feeding; introducing solid food to an infant's diet; feeding the preschooler; and avoiding mealtime battles. An appendix looks at a wide range of disorders including allergies, asthma, and hyperactivity, and how to teach a child who is reluctant to eat. The author also discusses the benefits and drawbacks of giving young children vitamins.

There is ample evidence that children and adolescents in large numbers are actively using integrative (complementary and alternative) therapies. Various studies now indicate that over 50% of pediatricians surveyed would refer a patient for integrative therapy, and they would welcome more natural therapies for children provided they were safe and effective. However, there has been little training for pediatricians in this area. Integrative Pediatrics addresses these issues and provides guidelines for pediatricians, parents, and general audiences in a balanced, evidence-based manner. In this volume in the Weil Integrative Medicine Library series, the authors describe a rational and evidence-based approach to the integrative therapy of childhood disorders and well-child care, integrating the principles of alternative and complementary therapies into the principles and practice of conventional pediatrics. The authors examine what works and what doesn't and offer practical guidelines for physicians to incorporate integrative medicine into their practice and how to advise patients and their parents on reasonable and effective therapies. The text also covers areas of controversy and identifies areas of uncertainty where future research is needed. Chapters also cite the best available evidence for both safety and efficacy of all therapies discussed. The series editor is Andrew Weil, MD, Professor and Director of the Program of Integrative Medicine at the University of Arizon. Dr. Weil's program was the first academic program in the US and he is the major name in integrative medicine in the US, and well-known around the world. His program's stated goal is "to combine the best ideas and practices of conventional and alternative medicine into cost effective treatments without embracing alternative practices uncritically."