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.
*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.
Address correspondence and reprint requests to Professor Berthold Koletzko, Dr med Dr med habil, MD, PhD, Division of Metabolic and Nutritional Medicine, Dr von Hauner Children's Hospital Ludwig-Maximilians-University, Lindwurmstr 4, 80337 München, Germany (e-mail: email@example.com).
Received 9 December, 2013
Accepted 14 December, 2013
This study was supported by the European Association of Perinatal Medicine, the European Board of Colleges of Obstetricians and Gynaecologists, the European Foundation for the Care of Newborn Infants, and the European Society of Human Reproduction and Embryology.
The workshop was jointly organised and cofunded by the European Society for Pediatric Gastroenterology, Hepatology and Nutrition (www.espghan.org) and the Early Nutrition Academy (early-nutrition.org), with partial financial support by the Commission of the European Community, specific RTD Programme “Quality of Life and Management of Living Resources,” within the 7th Framework Programme, research grant no. FP7/2007-13 (EarlyNutrition Project; www.project-earlynutrition.eu) and the European Research Council Advanced Grant ERC-2012-AdG—no. 322605 META-GROWTH. This article does not necessarily reflect the views of the Commission and in no way anticipates future policy in this area.
The authors report receiving grants and other compensation from the following entities: B.K.: European Commission, European Research Council (member of National Breastfeeding Committee and tends to bias towards breast-feeding; Ludwig-Maximilians-University of Munich and its employee, B.K., have received support for scientific and educational activities by companies that market parenteral nutrition products [eg, Baxter, B.Braun, Fresenius Kabi] and companies that market human milk fortifiers or infant formulae [eg, Abbott Nutrition, Danone, Fonterra, Mead Johnson, Nestlé], predominantly as part of publically funded research projects with support of the European Commission or the German government); M.A.B.: Shire, Sucampo; K.M.G.: Abbott Nutrition, Danone, International Life Sciences Institute, Nestec, Nestlé Nutrition, UK Medical Research Council; S. Kolaček: Abbott Nutrition, Arla Foods, B.Braun, Bio Gaia, Fresenius, Falk, Merck-Sharpe-Dohme, Nestlé, Nutricia (her institution received compensation from Abbott, BioGaia, Dukat, Nestlé, Nutricia, Podravka); S. Koletzko: Abbott, Danone, Fresenius, HiPP, Merck-Sharpe-Dohme, Nestlé, Phadia (her institution received grants from Mead Johnson, Nestlé Nutrition); F.M.M.: European Commission's 7th Framework Programme for Research and Technological Development, Irish Medical Council, Pfizer, University College Dublin; D.O.: Cambridge University Press; A.P.: ESPGHAN; P.S.: Nestlé, Nutricia, Nutricia/Danone, Sequoia; H.S.: Abbott, Arla, BioGaia, Biocodex, Danone, Dicofarm, ESPGHAN, Nestlé, Nestlé Nutrition Institute, Nutricia, Mead Johnson, Sequoia; N.T.: Abbott Nutrition, Danone, Sucampo; Y.V.: Biocodex, United Pharmaceuticals; G.V.: ESPGHAN. The other authors report no conflicts of interest.