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PMC full text:
J Med Ethics. Author manuscript; available in PMC 2013 Feb 13.
Published in final edited form as:
J Med Ethics. 2011 Jun; 37(6): 368–373.
Published online 2011 Mar 23. doi: 10.1136/jme.2010.039255

Table 2

Number (%) of recovered source documents by country and/or alliance and type of issuing body*. Countries included all those with >700 active clinical trials as of 24 July 2008

Regulatory agencyGovernment collaborationResearch sponsorNon-profit non-governmental organisationAdvisory bodyProfessional societyTrade organisationTotal by origin
Countries
 USA119 (39.4)02 (0.7)10 (3.3)29 (9.6)140 (46.4)2 (0.7)302
 Argentina1 (50.0)00001 (50.0)02
 Australia7 (33.3)0007 (33.3)3 (14.3)4 (19.0)21
 Austria2 (66.7)0001 (33.3)003
 Belgium6 (100.0)0000006
 Brazil2 (40.0)0003 (60.0)005
 Canada18 (50.0)09 (25.0)03 (8.3)6 (16.7)036
 China10 (76.9)0003 (23.1)0013
 Czech Republic10 (83.3)00002 (16.7)012
 Denmark14 (77.8)0001 (5.6)03 (16.7)18
 Finland4 (50.0)01 (12.5)03 (37.5)008
 France2 (14.3)00012 (85.7)0014
 Germany6 (42.9)02 (14.3)05 (35.7)1 (7.1)014
 Hungary9 (100.0)0000009
 India7 (33.3)00012 (57.1)02 (9.5)21
 Israel1 (25.0)002 (50.0)01 (25.0)04
 Italy2 (66.7)0001(33.3)003
 Japan8 (72.2)00002 (18.2)1 (9.1)11
 Mexico00000000
 The Netherlands15 (83.3)0001 (5.6)2 (11.1)018
 Norway14 (73.7)0003 (15.8)1 (5.3)1 (5.3)19
 Poland4 (100.0)0000004
 Puerto Rico00000000
 Russia2 (50.0)00002 (50.0)04
 Spain1 (50.0)01 (50.0)00002
 South Africa27 (55.1)010 (20.4)7 (14.3)1 (2.0)4 (8.2)049
 South Korea2 (66.7)001 (33.3)0003
 Sweden10 (58.8)06 (35.3)01 (5.9)0017
 Switzerland9 (69.2)00004 (30.8)013
 Taiwan5 (100.0)0000005
 UK79 (38.0)021 (10.1)3 (1.4)45 (21.6)42 (20.2)18 (8.7)208
 Subtotal by type3970522313121031844
Alliances
 Africa02 (40.0)1 (20.0)002 (40.0)05
 Asia1 (50.0)00001 (50.0)02
 Australasia000003 (100.0)03
 Eastern Europe01 (100.0)000001
 Europe33 (52.4)14 (22.2)4 (6.3)2 (3.2)1 (1.6)9 (14.3)063
 Latin America01 (100.0)000001
 North America00004 (100.0)004
 Middle East03 (100.0)000003
 Nordic Countries000001 (100.0)01
 Global1 (1.3)38 (49.4)1 (1.3)3 (3.9)14 (18.2)20 (26.0)077
 Subtotal by type35596517360158
Grand total432595828148246311004
*Types of issuing bodies included: regulatory agency (a body within a government which sets and enforces standards within specific fields of activity and whose approval is required in order to conduct and/or continue activity within the field. Includes national health services as in UK and Canada.); government collaboration (a group comprised of governments or agencies within governments which have agreed to work together to realise common objectives. The members of the groups work together to achieve their aims, but independent governments retain decision-making powers. Includes multi-national organisations whose members are appointed by the states to represent the states, and organisations that are subgroups of multi-national organisations.); funding agency (a public or private sponsor that funds medical research); non-profit non-governmental organisation (a nonprofit group that operates outside of institutionalised governmental or political structures and that addresses a specific agenda of issues and interests); advisory body (a body comprised of individuals (or groups) who have or exercise the power to give advice, guidance, or counsel pertaining to practices within a specific field of activity. Members of the field often regard this advice as relevant, though the advice may be non-binding or binding in effect only); professional society (a group of individuals engaged in the same professional or in related professions, whose members organise formally to attain shared objectives. These objectives often focus on the role and identity of the professional and on professional development. If a medical specialty was on the list at http://www.abms.org/Who_We_Help/Physicians/specialties.aspx, a corresponding national-level professional group was sought, for each nation); and trade organisation (a group comprised of companies that manufacture similar products or provide similar services. The group organises to promote trade and investment and to ensure fair trade and compliance with trade laws and agreements).
We did not seek standards-issuing documents from the following types of entities: research groups based in a single institution (e.g., the University of Aberdeen), individual private corporations, or individual provinces or states (unless the respective national regulatory agency specifically referred to them in place of national regulations).