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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

Citation

Koletzko, B and Benninga, MA and Godfrey, KM and Hornnes, PJ and Kolacek, S and Koletzko, S and Lentze, MJ and Mader, S and McAuliffe, FM and Oepkes, D and Oddy, WH and Phillips, A and Rzehak, P and Socha, P and Szajewska, H and Symonds, ME and Taminiau, J and Thapar, N and Troncone, R and Vandenplas, Y and Veereman, G, 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, Journal of Pediatric Gastroenterology and Nutrition, 58, (4) pp. 525-530. ISSN 0277-2116 (2014) [Refereed Article]

DOI: doi:10.1097/MPG.0000000000000284

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.

Item Details

Item Type:Refereed Article
Keywords:biomedical research, clinical trials, drug industry, food industry, public-private sector partnership, research ethics
Research Division:Medical and Health Sciences
Research Group:Nutrition and Dietetics
Research Field:Clinical and Sports Nutrition
Objective Division:Health
Objective Group:Public Health (excl. Specific Population Health)
Objective Field:Nutrition
Author:Oddy, WH (Professor Wendy Oddy)
ID Code:107526
Year Published:2014
Web of Science® Times Cited:5
Deposited By:Menzies Institute for Medical Research
Deposited On:2016-03-17
Last Modified:2017-11-06
Downloads:0

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