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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

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
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
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.
0277-2116
525-530
Kolezko, B.
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Benninga, M.A.
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Godfrey, K.M.
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Hornnes, P.J.
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Kolacek, S.
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Koletzko, S.
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Lentze, M.J.
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Mader, S.
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McAuliffe, F.M.
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Oepkes, D.
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Oddy, W.H.
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Phillips, A.
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Rzehak, P.
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Socha, P.
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Szajewska, H.
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Symonds, M.E.
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Taminiau, J.
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Thapar, N.
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Troncone, R.
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Vanderplas, Y.
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Veereman, G.
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Kolezko, B.
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Benninga, M.A.
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Godfrey, K.M.
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Hornnes, P.J.
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Kolacek, S.
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Koletzko, S.
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Lentze, M.J.
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Mader, S.
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McAuliffe, F.M.
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Oepkes, D.
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Oddy, W.H.
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Phillips, A.
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Rzehak, P.
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Socha, P.
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Szajewska, H.
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Symonds, M.E.
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Taminiau, J.
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Thapar, N.
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Troncone, R.
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Vanderplas, Y.
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Veereman, G.
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Kolezko, B., Benninga, M.A., Godfrey, K.M., Hornnes, P.J., Kolacek, S., Koletzko, S., Lentze, M.J., Mader, S., McAuliffe, F.M., Oepkes, D., Oddy, W.H., Phillips, A., Rzehak, P., Socha, P., Szajewska, H., Symonds, M.E., Taminiau, J., Thapar, N., Troncone, R., Vanderplas, Y. and Veereman, G. (2014) 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 & Nutrition, 58 (4), 525-530. (doi:10.1097/MPG.0000000000000284). (PMID:24399212)

Record type: Article

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.

Full text not available from this repository.

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Published date: April 2014
Organisations: Faculty of Medicine

Identifiers

Local EPrints ID: 365854
URI: http://eprints.soton.ac.uk/id/eprint/365854
ISSN: 0277-2116
PURE UUID: f99071e4-e42b-4b0e-a760-795d96823f2a
ORCID for K.M. Godfrey: ORCID iD orcid.org/0000-0002-4643-0618

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Date deposited: 17 Jun 2014 10:57
Last modified: 07 Oct 2020 01:35

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Contributors

Author: B. Kolezko
Author: M.A. Benninga
Author: K.M. Godfrey ORCID iD
Author: P.J. Hornnes
Author: S. Kolacek
Author: S. Koletzko
Author: M.J. Lentze
Author: S. Mader
Author: F.M. McAuliffe
Author: D. Oepkes
Author: W.H. Oddy
Author: A. Phillips
Author: P. Rzehak
Author: P. Socha
Author: H. Szajewska
Author: M.E. Symonds
Author: J. Taminiau
Author: N. Thapar
Author: R. Troncone
Author: Y. Vanderplas
Author: G. Veereman

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