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 agency | Government collaboration | Research sponsor | Non-profit non-governmental organisation | Advisory body | Professional society | Trade organisation | Total by origin | |
|---|---|---|---|---|---|---|---|---|
| Countries | ||||||||
| USA | 119 (39.4) | 0 | 2 (0.7) | 10 (3.3) | 29 (9.6) | 140 (46.4) | 2 (0.7) | 302 |
| Argentina | 1 (50.0) | 0 | 0 | 0 | 0 | 1 (50.0) | 0 | 2 |
| Australia | 7 (33.3) | 0 | 0 | 0 | 7 (33.3) | 3 (14.3) | 4 (19.0) | 21 |
| Austria | 2 (66.7) | 0 | 0 | 0 | 1 (33.3) | 0 | 0 | 3 |
| Belgium | 6 (100.0) | 0 | 0 | 0 | 0 | 0 | 0 | 6 |
| Brazil | 2 (40.0) | 0 | 0 | 0 | 3 (60.0) | 0 | 0 | 5 |
| Canada | 18 (50.0) | 0 | 9 (25.0) | 0 | 3 (8.3) | 6 (16.7) | 0 | 36 |
| China | 10 (76.9) | 0 | 0 | 0 | 3 (23.1) | 0 | 0 | 13 |
| Czech Republic | 10 (83.3) | 0 | 0 | 0 | 0 | 2 (16.7) | 0 | 12 |
| Denmark | 14 (77.8) | 0 | 0 | 0 | 1 (5.6) | 0 | 3 (16.7) | 18 |
| Finland | 4 (50.0) | 0 | 1 (12.5) | 0 | 3 (37.5) | 0 | 0 | 8 |
| France | 2 (14.3) | 0 | 0 | 0 | 12 (85.7) | 0 | 0 | 14 |
| Germany | 6 (42.9) | 0 | 2 (14.3) | 0 | 5 (35.7) | 1 (7.1) | 0 | 14 |
| Hungary | 9 (100.0) | 0 | 0 | 0 | 0 | 0 | 0 | 9 |
| India | 7 (33.3) | 0 | 0 | 0 | 12 (57.1) | 0 | 2 (9.5) | 21 |
| Israel | 1 (25.0) | 0 | 0 | 2 (50.0) | 0 | 1 (25.0) | 0 | 4 |
| Italy | 2 (66.7) | 0 | 0 | 0 | 1(33.3) | 0 | 0 | 3 |
| Japan | 8 (72.2) | 0 | 0 | 0 | 0 | 2 (18.2) | 1 (9.1) | 11 |
| Mexico† | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| The Netherlands | 15 (83.3) | 0 | 0 | 0 | 1 (5.6) | 2 (11.1) | 0 | 18 |
| Norway | 14 (73.7) | 0 | 0 | 0 | 3 (15.8) | 1 (5.3) | 1 (5.3) | 19 |
| Poland | 4 (100.0) | 0 | 0 | 0 | 0 | 0 | 0 | 4 |
| Puerto Rico† | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Russia | 2 (50.0) | 0 | 0 | 0 | 0 | 2 (50.0) | 0 | 4 |
| Spain | 1 (50.0) | 0 | 1 (50.0) | 0 | 0 | 0 | 0 | 2 |
| South Africa | 27 (55.1) | 0 | 10 (20.4) | 7 (14.3) | 1 (2.0) | 4 (8.2) | 0 | 49 |
| South Korea | 2 (66.7) | 0 | 0 | 1 (33.3) | 0 | 0 | 0 | 3 |
| Sweden | 10 (58.8) | 0 | 6 (35.3) | 0 | 1 (5.9) | 0 | 0 | 17 |
| Switzerland | 9 (69.2) | 0 | 0 | 0 | 0 | 4 (30.8) | 0 | 13 |
| Taiwan | 5 (100.0) | 0 | 0 | 0 | 0 | 0 | 0 | 5 |
| UK | 79 (38.0) | 0 | 21 (10.1) | 3 (1.4) | 45 (21.6) | 42 (20.2) | 18 (8.7) | 208 |
| Subtotal by type | 397 | 0 | 52 | 23 | 131 | 210 | 31 | 844 |
| Alliances | ||||||||
| Africa | 0 | 2 (40.0) | 1 (20.0) | 0 | 0 | 2 (40.0) | 0 | 5 |
| Asia | 1 (50.0) | 0 | 0 | 0 | 0 | 1 (50.0) | 0 | 2 |
| Australasia | 0 | 0 | 0 | 0 | 0 | 3 (100.0) | 0 | 3 |
| Eastern Europe | 0 | 1 (100.0) | 0 | 0 | 0 | 0 | 0 | 1 |
| Europe | 33 (52.4) | 14 (22.2) | 4 (6.3) | 2 (3.2) | 1 (1.6) | 9 (14.3) | 0 | 63 |
| Latin America | 0 | 1 (100.0) | 0 | 0 | 0 | 0 | 0 | 1 |
| North America | 0 | 0 | 0 | 0 | 4 (100.0) | 0 | 0 | 4 |
| Middle East | 0 | 3 (100.0) | 0 | 0 | 0 | 0 | 0 | 3 |
| Nordic Countries | 0 | 0 | 0 | 0 | 0 | 1 (100.0) | 0 | 1 |
| Global | 1 (1.3) | 38 (49.4) | 1 (1.3) | 3 (3.9) | 14 (18.2) | 20 (26.0) | 0 | 77 |
| Subtotal by type | 35 | 59 | 6 | 5 | 17 | 36 | 0 | 158 |
| Grand total | 432 | 59 | 58 | 28 | 148 | 246 | 31 | 1004 |
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).