title: 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.
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.
authors.affiliation: *Dr von Hauner Children's Hospital, Ludwig-Maximilians-University, Munich, Germany †Emma Children's Hospital/Academic Medical Centre, Department of Pediatric Gastroenterology & Nutrition, Amsterdam, The Netherlands ‡MRC Lifecourse Epidemiology Unit and NIHR Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK §Gynecology and Obstetrics, Hvidovre Hospital, Copenhagen, Denmark ||Children's Hospital Zagreb University Medical School, Zagreb, Croatia ¶Children's Hospital Medical Center, University Hospitals, Bonn, Germany #European Foundation for the Care of Newborn Infants, Munich, Germany **UCD Obstetrics & Gynaecology, School of Medicine and Medical Science, University College Dublin, National Maternity Hospital, Dublin, Ireland ††Department of Obstetrics, Leiden University Medical Centre, Leiden, The Netherlands ‡‡Telethon Institute for Child Health Research, Centre for Child Health Research, University of Western Australia, West Perth, Australia §§UCL Institute of Child Health, London, UK ||||Children's Memorial Health Institute ¶¶Department of Paediatrics, Medical University of Warsaw, Poland ##Academic Division of Child Health, School of Clinical Sciences, University of Nottingham, Nottingham, UK ***European Medicine Agency, Emma Children's Hospital, Academic Medical Centre, Amsterdam, The Netherlands †††UCL Institute of Child Health, Great Ormond Street Hospital, London, UK ‡‡‡Department of Paediatrics, Universita degli Studi di Napoli Frederico II, Naples, Italy §§§Department of Paediatrics, UZ Brussel, Vrije Universiteit Brussel, Brussels, Belgium.
authors.forename: Berthold
authors.initials: B
authors.lastname: Koletzko
authors.forename: Marc A
authors.initials: MA
authors.lastname: Benninga
authors.forename: Keith M
authors.initials: KM
authors.lastname: Godfrey
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Hornnes
authors.forename: Sanja
authors.initials: S
authors.lastname: Kolaček
authors.forename: Sibylle
authors.initials: S
authors.lastname: Koletzko
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Lentze
authors.forename: Silke
authors.initials: S
authors.lastname: Mader
authors.forename: Fionnuala M
authors.initials: FM
authors.lastname: McAuliffe
authors.forename: Dick
authors.initials: D
authors.lastname: Oepkes
authors.forename: Wendy H
authors.initials: WH
authors.lastname: Oddy
authors.forename: Alan
authors.initials: A
authors.lastname: Phillips
authors.forename: Peter
authors.initials: P
authors.lastname: Rzehak
authors.forename: Piotr
authors.initials: P
authors.lastname: Socha
authors.forename: Hania
authors.initials: H
authors.lastname: Szajewska
authors.forename: Michael E
authors.initials: ME
authors.lastname: Symonds
authors.forename: Jan
authors.initials: J
authors.lastname: Taminiau
authors.forename: Nikhil
authors.initials: N
authors.lastname: Thapar
authors.forename: Riccardo
authors.initials: R
authors.lastname: Troncone
authors.forename: Yvan
authors.initials: Y
authors.lastname: Vandenplas
authors.forename: Gigi
authors.initials: G
authors.lastname: Veereman
mesh_terms: D035843:Biomedical Research / Q000941:ethics* / Q000592:standards*; D001942:Breast Feeding; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D004345:Drug Industry; D005260:Female; D006801:Humans; D007223:Infant; D011247:Pregnancy; D055818:Public-Private Sector Partnerships / Q000941:ethics* / Q000592:standards*; D014495:Universities