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Sharing and reuse of individual participant data from clinical trials: principles and recommendations.
Ohmann C, Banzi R, Canham S, Battaglia S, Matei M, Ariyo C, Becnel L, Bierer B, Bowers S, Clivio L, Dias M, Druml C, Faure H, Fenner M, Galvez J, Ghersi D, Gluud C, Groves T, Houston P, Karam G, Kalra D, Knowles RL, Krleža-Jerić K, Kubiak C, Kuchinke W, Kush R, Lukkarinen A, Marques PS, Newbigging A, O'Callaghan J, Ravaud P, Schlünder I, Shanahan D, Sitter H, Spalding D, Tudur-Smith C, van Reusel P, van Veen EB, Visser GR, Wilson J, Demotes-Mainard J. Ohmann C, et al. Among authors: gluud c. BMJ Open. 2017 Dec 14;7(12):e018647. doi: 10.1136/bmjopen-2017-018647. BMJ Open. 2017. PMID: 29247106 Free PMC article.
Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN).
Kubiak C, de Andres-Trelles F, Kuchinke W, Huemer KH, Thirstrup S, Whitfield K, Libersa C, Barraud B, Grählert X, Dreier G, Grychtol R, Temesvari Z, Blasko G, Kardos G, O'Brien T, Cooney M, Gaynor S, Schieppati A, Sanz N, Hernandez R, Asker-Hagelberg C, Johansson H, Bourne S, Byrne J, Asghar A, Husson JM, Gluud C, Demotes-Mainard J. Kubiak C, et al. Among authors: gluud c. Trials. 2009 Oct 16;10:95. doi: 10.1186/1745-6215-10-95. Trials. 2009. PMID: 19835581 Free PMC article.
Compassionate use of interventions: results of a European Clinical Research Infrastructures Network (ECRIN) survey of ten European countries.
Whitfield K, Huemer KH, Winter D, Thirstrup S, Libersa C, Barraud B, Kubiak C, Stankovski L, Grählert X, Dreier G, Geismann S, Kuchinke W, Strenge-Hesse A, Temesvari Z, Blasko G, Kardos G, O'Brien T, Cooney M, Gaynor S, Schieppati A, Serrano M, de Andres F, Sanz N, Hernández R, Kreis G, Asker-Hagelberg C, Johansson H, Asghar A, Husson JM, Demotes J, Gluud C. Whitfield K, et al. Among authors: gluud c. Trials. 2010 Nov 12;11:104. doi: 10.1186/1745-6215-11-104. Trials. 2010. PMID: 21073691 Free PMC article.
EMA's reflection on placebo does not reflect patients' interests.
Bertele' V, Banzi R, Gluud C, Garattini S. Bertele' V, et al. Among authors: gluud c. Eur J Clin Pharmacol. 2012 May;68(5):877-9. doi: 10.1007/s00228-011-1175-4. Epub 2011 Dec 2. Eur J Clin Pharmacol. 2012. PMID: 22134525 No abstract available.
Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries.
Gluud C, Kubiak C, Whitfield K, Byrne J, Huemer KH, Thirstrup S, Libersa C, Barraud B, Grählert X, Dreier G, Geismann S, Kuchinke W, Temesvari Z, Blasko G, Kardos G, O'Brien T, Cooney M, Gaynor S, Schieppati A, de Andres F, Sanz N, Kreis G, Asker-Hagelberg C, Johansson H, Bourne S, Asghar A, Husson JM, Demotes-Mainard J. Gluud C, et al. Trials. 2012 Mar 27;13:27. doi: 10.1186/1745-6215-13-27. Trials. 2012. PMID: 22452964 Free PMC article.
Fostering EMA's transparency policy.
Banzi R, Bertele' V, Demotes-Mainard J, Garattini S, Gluud C, Kubiak C, Ohmann C. Banzi R, et al. Among authors: gluud c. Eur J Intern Med. 2014 Oct;25(8):681-4. doi: 10.1016/j.ejim.2014.07.012. Epub 2014 Sep 6. Eur J Intern Med. 2014. PMID: 25200801
A European multi-language initiative to make the general population aware of independent clinical research: the European Communication on Research Awareness Need project.
Mosconi P, Antes G, Barbareschi G, Burls A, Demotes-Mainard J, Chalmers I, Colombo C, Garattini S, Gluud C, Gyte G, Mcllwain C, Penfold M, Post N, Satolli R, Valetto MR, West B, Wolff S. Mosconi P, et al. Among authors: gluud c. Trials. 2016 Jan 12;17:19. doi: 10.1186/s13063-015-1146-7. Trials. 2016. PMID: 26758509 Free PMC article.
Evidence-based clinical practice: Overview of threats to the validity of evidence and how to minimise them.
Garattini S, Jakobsen JC, Wetterslev J, Bertelé V, Banzi R, Rath A, Neugebauer EA, Laville M, Masson Y, Hivert V, Eikermann M, Aydin B, Ngwabyt S, Martinho C, Gerardi C, Szmigielski CA, Demotes-Mainard J, Gluud C. Garattini S, et al. Among authors: gluud c. Eur J Intern Med. 2016 Jul;32:13-21. doi: 10.1016/j.ejim.2016.03.020. Epub 2016 May 6. Eur J Intern Med. 2016. PMID: 27160381 Review.
Barriers to the conduct of randomised clinical trials within all disease areas.
Djurisic S, Rath A, Gaber S, Garattini S, Bertele V, Ngwabyt SN, Hivert V, Neugebauer EAM, Laville M, Hiesmayr M, Demotes-Mainard J, Kubiak C, Jakobsen JC, Gluud C. Djurisic S, et al. Among authors: gluud c. Trials. 2017 Aug 1;18(1):360. doi: 10.1186/s13063-017-2099-9. Trials. 2017. PMID: 28764809 Free PMC article. Review.
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