Koletzko Berthold, Benninga Marc A, Godfrey Keith M, Hornnes Peter J, Kolaček Sanja, Koletzko Sibylle, Lentze Michael J, Mader Silke, McAuliffe Fionnuala M, Oepkes Dick, Oddy Wendy H, Phillips Alan, Rzehak Peter, Socha Piotr, Szajewska Hania, Symonds Michael E, Taminiau Jan, Thapar Nikhil, Troncone Riccardo, Vandenplas Yvan, Veereman Gigi
*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.
J Pediatr Gastroenterol Nutr. 2014 Apr;58(4):525-30. doi: 10.1097/MPG.0000000000000284.
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.
本立场声明总结了学术界对于与商业企业合作开展临床研究的标准的观点，重点关注针对孕妇、哺乳期妇女及儿童的试验。它基于对现有文献的综述以及由早期营养学会和欧洲儿科胃肠病、肝病和营养学会共同主办的一次专家研讨会。大学、公共资助机构和政府组织鼓励学术研究人员与商业企业开展临床研究合作。一个原因是迫切需要获取有关药物及其他商业产品和服务的效果、安全性和益处的证据。然而，通过公私合作研究获得的结果的可信度和价值受到了质疑，因为已经出现了许多不当研究行为的例子。针对孕妇、哺乳期妇女以及婴幼儿的临床研究引发了敏感的科学、伦理和社会问题，需要应用特别高的标准。在此，我们针对在这些人群中开展公私合作研究提供建议。为了所有利益相关者的利益，这些建议应有助于使商业赞助试验产生更可靠、可信且可接受的结果，并缩小现有的可信度差距。
