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Public private collaboration in clinical research during pregnancy, lactation and childhood. A joint position statement of the early nutrition academy (ENA) and the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN)

Tijdschriftbijdrage - Tijdschriftartikel

This position statement summarises a view of academia regarding standards for clinical research in collaboration with commercial enterprises, focussing on trials in pregnant women, breastfeeding women and children. It is based on a review of the available literature and an expert workshop co-sponsored by the Early Nutrition Academy and the European Society for Paediatric Gastroenterology, Hepatology and Nutrition. Clinical research collaborations between academic investigators and commercial enterprises are encouraged by universities, public funding agencies and governmental organisations. One reason is a pressing need to obtain evidence on the effects, safety and benefits of drugs and other commercial products and services. However, the credibility and value of results obtained through public private research collaborations have been questioned, since many examples of inappropriate research practice have become known. Clinical research in pregnant and breastfeeding women, and in infants and children, raise sensitive scientific, ethical and societal questions and require the application of particularly high standards. Here we provide recommendations for the conduct of public private research collaborations in these populations. In the interest of all stakeholders these recommendations should contribute to more reliable, credible and acceptable results of commercially sponsored trials and to reducing the existing credibility gap.
Tijdschrift: J Pediatr Gastroenterol Hepatol 2000;31:480-489
ISSN: 0277-2116
Issue: 4
Volume: 58
Pagina's: 525-530
Jaar van publicatie:2014
Trefwoorden:public private collaboration
  • Scopus Id: 84897429663