The Trials of Youth: Bringing Children Into Clinical Research


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    The memories of childhood often include long summer days, longer school days, skinned knees, and broken hearts. These images are seldom associated with long treks to clinics, waiting to see doctors, and taking experimental medicines. But for seriously ill children participating in clinical research, these experiences are all too real.
    Once considered unethical to conduct clinical studies of new medications in children, now it is considered unethical — and some even say immoral — to offer medical treatment to a vulnerable population with inadequate information about how those patients will respond.
    From a pharmacotherapeutic perspective, developmental variations clearly indicate that a child should not be treated simply as a smaller version of an adult, according to a Kalorama Information report, The Worldwide Market for Prescription Pediatric Drugs. Children of different ages absorb, distribute, metabolize, and excrete drugs in different ways.

World Market For Prescription Pediatric Drugs
Protecting a Vulnerable Population
The Dilemma of Off-Patent Products

Though Leaders
Wayne Matthew Dankner, M.D. Senior Medical Director, Parexel International Corp., Waltham, Mass.; Parexel is one of the largest biopharmaceutical outsourcing organizations, providing a broad range of contract research, medical marketing, and consulting services to the worldwide pharmaceutical, biotechnology, and medical-device industries. For more information, visit
Cameron Durrant, M.D., MBA. President, PediaMed Pharmaceuticals Inc., Florence, Ky.; PediaMed identifies, develops, and markets prescription pharmaceutical and nonprescription medicines that improve the well-being of infants, children, adolescents, and young adults. For more information, visit
James R. Hildebrand III, Pharm.D. Director of Clinical Pharmacology, The Alfred I. duPont Hospital for Children, Wilmington, Del.; The Alfred I. duPont Hospital for Children is a division of Nemours, which operates one of the nation’s largest group medical practices devoted to pediatric patient care, teaching, and research. For more information, visit
Sam Kazman. General Counsel for the Competitive Enterprise Institute, Washington, D.C.; The CEI is a nonprofit, nonpartisan public group dedicated to the principles of free enterprise and limited government. For more information, visit
Mark Schreiner, M.D. Executive Medical Director, Children’s Clinical Research Institute, Philadelphia; Children’s Clinical Research Institute, which is affiliated with The Children’s Hospital of Philadelphia, is a nonprofit, full-service clinical research organization whose mission is to advocate for the advancement of pediatric healthcare. For more information, visit
Christy Shaffer, Ph.D. CEO, Inspire Pharmaceuticals Inc., Durham, N.C.; Inspire Pharmaceuticals discovers and develops new drugs to treat diseases characterized by deficiencies in the body’s innate defense mechanisms of mucosal hydration and mucociliary clearance, as well as other nonmucosal disorders. For more information, visit
Vera Sharav. President, The Alliance for Human Research Protection, New York; The AHRP is a grassroots organization with a mission to protect children from harmful medical experiments. For more information, visit
Jeff Trewhitt. Pharmaceutical Research and Manufacturers of America, Washington, D.C.; PhRMA represents the country’s leading research-based pharmaceutical and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. For more information, visit
John Yee, M.D., M.P.H. BBK Healthcare Inc., Newton, Mass.; BBK Healthcare is a full-service patient recruitment consulting firm whose services include strategic consultation, investigative site recruitment, and patient recruitment. For more information, visit