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Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN)

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

Standard

Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN). / Kubiak, Christine; de Andres-Trelles, Fernando; Kuchinke, Wolfgang; Huemer, Karl-Heinz; Thirstrup, Steffen; Whitfield, Kate; Libersa, Christian; Barraud, Béatrice; Grählert, Xina; Dreier, Gabriele; Grychtol, Ruth; Temesvari, Zsuzsa; Blasko, Gyorgy; Kardos, Gabriella; O'Brien, Timothy; Cooney, Margaret; Gaynor, Siobhan; Schieppati, Arrigo; Sanz, Nuria; Hernandez, Raquel; Asker-Hagelberg, Charlotte; Johansson, Hanna; Bourne, Sue; Byrne, Jane; Asghar, Adeeba; Husson, Jean-Marc; Gluud, Christian; Demotes-Mainard, Jacques.

I: Trials, Bind 10, 2009, s. 95.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

Harvard

Kubiak, C, de Andres-Trelles, F, Kuchinke, W, Huemer, K-H, 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, J-M, Gluud, C & Demotes-Mainard, J 2009, 'Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN)', Trials, bind 10, s. 95. https://doi.org/10.1186/1745-6215-10-95

APA

Kubiak, C., de Andres-Trelles, F., Kuchinke, W., Huemer, K-H., 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., ... Demotes-Mainard, J. (2009). Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN). Trials, 10, 95. https://doi.org/10.1186/1745-6215-10-95

Vancouver

Kubiak C, de Andres-Trelles F, Kuchinke W, Huemer K-H, Thirstrup S, Whitfield K o.a. Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN). Trials. 2009;10:95. https://doi.org/10.1186/1745-6215-10-95

Author

Kubiak, Christine ; de Andres-Trelles, Fernando ; Kuchinke, Wolfgang ; Huemer, Karl-Heinz ; Thirstrup, Steffen ; Whitfield, Kate ; Libersa, Christian ; Barraud, Béatrice ; Grählert, Xina ; Dreier, Gabriele ; Grychtol, Ruth ; Temesvari, Zsuzsa ; Blasko, Gyorgy ; Kardos, Gabriella ; O'Brien, Timothy ; Cooney, Margaret ; Gaynor, Siobhan ; Schieppati, Arrigo ; Sanz, Nuria ; Hernandez, Raquel ; Asker-Hagelberg, Charlotte ; Johansson, Hanna ; Bourne, Sue ; Byrne, Jane ; Asghar, Adeeba ; Husson, Jean-Marc ; Gluud, Christian ; Demotes-Mainard, Jacques. / Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN). I: Trials. 2009 ; Bind 10. s. 95.

Bibtex

@article{0c196a006a3411df928f000ea68e967b,
title = "Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN)",
abstract = "BACKGROUND: Thorough knowledge of the regulatory requirements is a challenging prerequisite for conducting multinational clinical studies in Europe given their complexity and heterogeneity in regulation and perception across the EU member states. METHODS: In order to summarise the current situation in relation to the wide spectrum of clinical research, the European Clinical Research Infrastructures Network (ECRIN) developed a multinational survey in ten European countries. However a lack of common classification framework for major categories of clinical research was identified, and therefore reaching an agreement on a common classification was the initial step in the development of the survey. RESULTS: The ECRIN transnational working group on regulation, composed of experts in the field of clinical research from ten European countries, defined seven major categories of clinical research that seem relevant from both the regulatory and the scientific points of view, and correspond to congruent definitions in all countries: clinical trials on medicinal products; clinical trials on medical devices; other therapeutic trials (including surgery trials, transplantation trials, transfusion trials, trials with cell therapy, etc.); diagnostic studies; clinical research on nutrition; other interventional clinical research (including trials in complementary and alternative medicine, trials with collection of blood or tissue samples, physiology studies, etc.); and epidemiology studies. Our classification was essential to develop a survey focused on protocol submission to ethics committees and competent authorities, procedures for amendments, requirements for sponsor and insurance, and adverse event reporting following five main phases: drafting, consensus, data collection, validation, and finalising. CONCLUSION: The list of clinical research categories as used for the survey could serve as a contribution to the, much needed, task of harmonisation and simplification of the regulatory requirements for clinical research in Europe.",
author = "Christine Kubiak and {de Andres-Trelles}, Fernando and Wolfgang Kuchinke and Karl-Heinz Huemer and Steffen Thirstrup and Kate Whitfield and Christian Libersa and B{\'e}atrice Barraud and Xina Gr{\"a}hlert and Gabriele Dreier and Ruth Grychtol and Zsuzsa Temesvari and Gyorgy Blasko and Gabriella Kardos and Timothy O'Brien and Margaret Cooney and Siobhan Gaynor and Arrigo Schieppati and Nuria Sanz and Raquel Hernandez and Charlotte Asker-Hagelberg and Hanna Johansson and Sue Bourne and Jane Byrne and Adeeba Asghar and Jean-Marc Husson and Christian Gluud and Jacques Demotes-Mainard",
note = "Keywords: Biomedical Research; Clinical Trials as Topic; Data Collection; Europe; Humans",
year = "2009",
doi = "10.1186/1745-6215-10-95",
language = "English",
volume = "10",
pages = "95",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central Ltd.",

}

RIS

TY - JOUR

T1 - Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN)

AU - Kubiak, Christine

AU - de Andres-Trelles, Fernando

AU - Kuchinke, Wolfgang

AU - Huemer, Karl-Heinz

AU - Thirstrup, Steffen

AU - Whitfield, Kate

AU - Libersa, Christian

AU - Barraud, Béatrice

AU - Grählert, Xina

AU - Dreier, Gabriele

AU - Grychtol, Ruth

AU - Temesvari, Zsuzsa

AU - Blasko, Gyorgy

AU - Kardos, Gabriella

AU - O'Brien, Timothy

AU - Cooney, Margaret

AU - Gaynor, Siobhan

AU - Schieppati, Arrigo

AU - Sanz, Nuria

AU - Hernandez, Raquel

AU - Asker-Hagelberg, Charlotte

AU - Johansson, Hanna

AU - Bourne, Sue

AU - Byrne, Jane

AU - Asghar, Adeeba

AU - Husson, Jean-Marc

AU - Gluud, Christian

AU - Demotes-Mainard, Jacques

N1 - Keywords: Biomedical Research; Clinical Trials as Topic; Data Collection; Europe; Humans

PY - 2009

Y1 - 2009

N2 - BACKGROUND: Thorough knowledge of the regulatory requirements is a challenging prerequisite for conducting multinational clinical studies in Europe given their complexity and heterogeneity in regulation and perception across the EU member states. METHODS: In order to summarise the current situation in relation to the wide spectrum of clinical research, the European Clinical Research Infrastructures Network (ECRIN) developed a multinational survey in ten European countries. However a lack of common classification framework for major categories of clinical research was identified, and therefore reaching an agreement on a common classification was the initial step in the development of the survey. RESULTS: The ECRIN transnational working group on regulation, composed of experts in the field of clinical research from ten European countries, defined seven major categories of clinical research that seem relevant from both the regulatory and the scientific points of view, and correspond to congruent definitions in all countries: clinical trials on medicinal products; clinical trials on medical devices; other therapeutic trials (including surgery trials, transplantation trials, transfusion trials, trials with cell therapy, etc.); diagnostic studies; clinical research on nutrition; other interventional clinical research (including trials in complementary and alternative medicine, trials with collection of blood or tissue samples, physiology studies, etc.); and epidemiology studies. Our classification was essential to develop a survey focused on protocol submission to ethics committees and competent authorities, procedures for amendments, requirements for sponsor and insurance, and adverse event reporting following five main phases: drafting, consensus, data collection, validation, and finalising. CONCLUSION: The list of clinical research categories as used for the survey could serve as a contribution to the, much needed, task of harmonisation and simplification of the regulatory requirements for clinical research in Europe.

AB - BACKGROUND: Thorough knowledge of the regulatory requirements is a challenging prerequisite for conducting multinational clinical studies in Europe given their complexity and heterogeneity in regulation and perception across the EU member states. METHODS: In order to summarise the current situation in relation to the wide spectrum of clinical research, the European Clinical Research Infrastructures Network (ECRIN) developed a multinational survey in ten European countries. However a lack of common classification framework for major categories of clinical research was identified, and therefore reaching an agreement on a common classification was the initial step in the development of the survey. RESULTS: The ECRIN transnational working group on regulation, composed of experts in the field of clinical research from ten European countries, defined seven major categories of clinical research that seem relevant from both the regulatory and the scientific points of view, and correspond to congruent definitions in all countries: clinical trials on medicinal products; clinical trials on medical devices; other therapeutic trials (including surgery trials, transplantation trials, transfusion trials, trials with cell therapy, etc.); diagnostic studies; clinical research on nutrition; other interventional clinical research (including trials in complementary and alternative medicine, trials with collection of blood or tissue samples, physiology studies, etc.); and epidemiology studies. Our classification was essential to develop a survey focused on protocol submission to ethics committees and competent authorities, procedures for amendments, requirements for sponsor and insurance, and adverse event reporting following five main phases: drafting, consensus, data collection, validation, and finalising. CONCLUSION: The list of clinical research categories as used for the survey could serve as a contribution to the, much needed, task of harmonisation and simplification of the regulatory requirements for clinical research in Europe.

U2 - 10.1186/1745-6215-10-95

DO - 10.1186/1745-6215-10-95

M3 - Journal article

C2 - 19835581

VL - 10

SP - 95

JO - Trials

JF - Trials

SN - 1745-6215

ER -

ID: 20008207