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Overcome failure to Publish nEgative fiNdings

Objective

Full information about completed and ongoing clinical trials is the indispensable base for decision making about medical therapies and diagnostic procedures by patients and doctors. Equally, researchers and research organisations, ethics boards, governments and health system agencies, courts for social justice, pharmaceutical companies and all professional groups of the health care system are dependent on unbiased information.
Research projects have consistently shown that for approximately 50% of all launched trials results or reasons for their failure are never published. Not only pharmaceutical industry, but also researchers and their organisations, ethics boards and scientific journals are actively contributing to the general failure to come close to a 100% publication rate. An obvious reason is the complexity of the system as well as the limitation of resources, giving ample space for all stakeholders to avoid appropriate changes and draw attention to deficiencies outside their responsibility.
This project is based on the assumption that the existence of broad publication bias with seriously harmful impact has been accepted by all stakeholders and does not require further evidence. The current knowledge on publication bias and its impact will be summarized by systematic reviews of the relevant literature, with emphasis on the situation in the EU.
OPEN focuses on the investigation of attitudes and handling of stakeholders involved in the whole knowledge translation process. Surveys, case studies and analyses of policies to reduce publication bias will be conducted to describe the current views and practice of stakeholders who are involved in knowledge translation. These results will be brought together to describe the status quo. Based on those insights recommendations will be derived to reduce publication bias and thus foster the provision of relevant results from clinical trials to citizens and organisations in the EU.

Call for proposal

FP7-HEALTH-2011-single-stage
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Coordinator

UNIVERSITAETSKLINIKUM FREIBURG
Address
Hugstetter Strasse 49
79106 Freiburg
Germany

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Jürgen Dreyer
EU contribution
€ 101 911

Participants (10)

EBERHARD KARLS UNIVERSITAET TUEBINGEN
Germany
EU contribution
€ 43 763
Address
Geschwister-scholl-platz
72074 Tuebingen

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Dirk Bassler (Dr.)
INSTITUT DE RECERCA DE L'HOSPITAL DE LA SANTA CREU I SANT PAU FUNDACION
Spain
EU contribution
€ 57 929
Address
C Sant Quinti 77-79
08041 Barcelona

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Activity type
Research Organisations
Administrative Contact
Hilda Herrero (Ms.)
KLEIJNEN SYSTEMATIC REVIEWS LTD
United Kingdom
EU contribution
€ 36 594
Address
Riccall Road Unit 6
YO19 6FD Escrick York

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Jos Kleijnen (Dr.)
MEDIZINISCHE HOCHSCHULE HANNOVER
Germany
EU contribution
€ 35 898
Address
Carl-neuberg-strasse 1
30625 Hannover

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Daniel Strech (Prof.)
SVEUCILISTE U SPLITU
Croatia
EU contribution
€ 21 346
Address
Rudera Boskovica 31
21000 Split

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Ana Marusic (Prof.)
WORLD HEALTH ORGANIZATION
Switzerland
EU contribution
€ 60 936
Address
Avenue Appia 20
1211 Geneve

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Activity type
Research Organisations
Administrative Contact
Davina Ghersi (Dr.)
ELIZABETH WAGER (SIDEVIEW)
United Kingdom
EU contribution
€ 33 919
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Elizabeth Wager (Dr.)
ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
Italy
EU contribution
€ 36 594
Address
Via Mario Negri 2
20156 Milano

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Activity type
Research Organisations
Administrative Contact
Silvano Gallus (Dr.)
GEMEINSAMER BUNDESAUSSCHUSS
Germany
EU contribution
€ 35 898
Address
Wegelystrasse 8
10623 Berlin

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Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Thomas Gutekunst
Université Paris Descartes
France
EU contribution
€ 35 203
Address
Rue De L'ecole De Médecine
75270 cedex 06 Paris

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Philippe Ravaud (Prof.)