Public-private collaboration in clinical research during pregnancy, lactation, and childhood: joint position statement of the Early Nutrition Academy and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition

Berthold Koletzko, Marc A. Benninga, Keith M. Godfrey, Peter J. Hornnes, Sanja Kolaček, Sibylle Koletzko, Michael J. Lentze, Silke Mader, Fionnuala M. McAuliffe, Dick Oepkes, Wendy H. Oddy, Alan Phillips, Peter Rzehak, Piotr Socha, Hania Szajewska, Michael E. Symonds, Jan Taminiau, Nikhil Thapar, Riccardo Troncone, Yvan VandenplasGigi Veereman

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Abstract

This position statement summarises a view of academia regarding standards for clinical research in collaboration with commercial enterprises, focussing on trials in pregnant women, breast-feeding women, and children. It is based on a review of the available literature and an expert workshop cosponsored by the Early Nutrition Academy and the European Society for Pediatric 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. The credibility and value of results obtained through public-private research collaborations have, however, been questioned because many examples of inappropriate research practice have become known. Clinical research in pregnant and breast-feeding women, and in infants and children, raises sensitive scientific, ethical, and societal questions and requires 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
Original languageEnglish
Pages (from-to)525-530
JournalJournal of pediatric gastroenterology and nutrition
Volume58
Issue number4
DOIs
Publication statusPublished - 2014

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