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Enrollment of Neonates in More Than One Clinical Trial.
Davis, Jonathan M; Baer, Gerri R; Portman, Ronald; Nelson, Robert; Storari, Linda; Aranda, Jacob V; Bax, Ralph; Zajicek, Anne; Klein, Agnes; Turner, Mark; Baygani, Simin; Thomson, Merran; Allegaert, Karel.
Afiliación
  • Davis JM; Department of Pediatrics and the Tufts Clinical and Translational Science Institute, Tufts University, Boston, Massachusetts. Electronic address: jdavis@tuftsmedicalcenter.org.
  • Baer GR; US Food and Drug Administration, Office of Pediatric Therapeutics, Silver Spring, Maryland.
  • Portman R; Novartis Pharmaceuticals, East Hanover, New Jersey.
  • Nelson R; US Food and Drug Administration, Office of Pediatric Therapeutics, Silver Spring, Maryland.
  • Storari L; Chiesi Farmaceutici SpA, Parma, Italy.
  • Aranda JV; State University of New York at Downstate Medical Center, Brooklyn, New York.
  • Bax R; The European Medicines Agency, London, United Kingdom.
  • Zajicek A; The Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.
  • Klein A; Health Canada, Ottawa, Ontario, Canada.
  • Turner M; University of Liverpool, Liverpool, United Kingdom.
  • Baygani S; Eli Lilly & Co, Indianapolis, Indiana.
  • Thomson M; Hillingdon Hospital NHS Trust, Uxbridge, United Kingdom.
  • Allegaert K; Department of Development and Regeneration, KU Leuven, Leuven, Belgium; Intensive Care and Department of Pediatric Surgery, Erasmus MC-Sophia Children's Hospital, Rotterdam, the Netherlands.
Clin Ther ; 39(10): 1959-1969, 2017 Oct.
Article en En | MEDLINE | ID: mdl-28987269
Because the highest rates of morbidity and mortality in neonates are seen in those born at <32 weeks' gestation, this group has the most urgent need for novel therapies to improve survival and outcome. Legislative efforts in the United States and Europe have attempted to address this issue by requiring the study of drugs, biological and nutritional products, devices, and other therapies in this population through a combination of high-quality regulatory and clinical trials, quality improvement initiatives, and observational studies. Because there are relatively small numbers of very preterm neonates born each year in any 1 country or continent, and because a significant number of clinical trials are recruiting at any 1 time, a neonate may meet enrollment criteria for >1 clinical trial. Neonatal units that have the infrastructure and resources to engage in research frequently face the question of whether it is permissible to enroll a neonate in >1 trial. This article examines the pertinent scientific, ethical, regulatory, and industry issues that should be taken into account when considering enrolling neonates in multiple clinical studies.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Ensayos Clínicos como Asunto Tipo de estudio: Observational_studies / Prognostic_studies Aspecto: Ethics Límite: Humans / Newborn Idioma: En Revista: Clin Ther Año: 2017 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Ensayos Clínicos como Asunto Tipo de estudio: Observational_studies / Prognostic_studies Aspecto: Ethics Límite: Humans / Newborn Idioma: En Revista: Clin Ther Año: 2017 Tipo del documento: Article Pais de publicación: Estados Unidos