Table 2 List of all broad themes in the 2009 and 2011 public consultation

1

Trial application, assessment and approval

Comments on difficulties with regard to trial application and approval; options to streamline and speed up the assessment

238

60

25

90

32

1

25

2

3

2

Text and form of legislative act

Problems with divergent interpretation of definitions, e.g. ‘non-interventional trials’; comments on the form of the law and the revision of accompanying guidelines

77

28

14

13

10

0

10

2

0

3

Sponsorship of trials

Comments on multiple sponsorship and the possibility to exclude academic sponsors from the regulation

72

32

12

15

11

0

1

1

0

4

SUSAR Reporting (Suspected Unexpected Serious Adverse Reactions)

Problems with the current method of SUSAR reporting and options for improvement

56

11

8

10

17

2

8

0

0

5

Third countries

Options to improve GCP compliance in third countries

43

26

5

8

3

0

1

0

0

6

Regulation of specific trials

Problems with regard to specific trials, e.g. paediatric or emergency trials

34

13

7

9

2

2

1

0

0

7

General comments

Comments on data presented by the European Commission; comments on the EU as a site for clinical research; problems with delays in starting trials, and decline in number of trials conducted and subjects enrolled in trials

34

4

8

9

6

0

6

0

1

8

Risk classification

Comments on the possibility and necessity of a risk-based approach to trial legislation

33

14

4

5

4

0

5

1

0

9

Divergent national application of CTD

General comments on negative effects of the divergent application of legislation in the different member states

32

7

4

13

6

0

0

0

2

10

Resources and costs

Comments around management of administrative costs

25

6

6

9

3

0

0

1

0

11

Improvements since 2004

Comments on positive aspects of introduction of CTD, e.g. patient protection and standardization

25

6

5

4

6

0

4

0

0

12

Trial insurance

Comments on aspects of harmonized trial insurance

7

4

1

1

0

0

0

1

0

Total codes

676

211

99

186

100

5

61

8

6

1

Trial application, assessment and approval

Comments on policy options: central submission of trial applications, central assessment versus coordinated assessment involving all member states concerned; comments on the possibility of a pre-assessment of trials, including lesser requirements for low-risk trials

429

101

36

139

78

29

2

29

15

2

Text and form of legislative act

Proposals for clearer definitions of central concepts, e.g. “non-interventional trial” and “Investigational Medicinal Product”

96

19

13

33

16

7

2

4

2

3

Sponsorship of trials

Comments on multiple sponsorship and the possibility to exclude academic sponsors from the regulation

82

22

6

21

12

8

0

9

4

4

Insurance

Comments on the responsibility for insurance and on a proposed risk-based approach for insurance requirements

52

13

5

17

6

1

0

6

4

5

Risk assessment

Options for a general risk-based approach by the legislation, with special regard to application approval and safety reporting

24

11

5

5

0

1

0

0

2

6

Third countries

Comments on registration of third country trials in European databases and the assessment and inspection of trial sites outside the EU

24

12

0

6

3

0

0

1

2

7

Informed consent

Proposals to improve provisions for obtaining consent from trial participants

13

3

2

1

2

0

1

4

0

8

Safety reporting and vigilance

Comments on the functioning of safety reporting

11

1

0

2

8

0

0

0

0

9

Trials in emergency situations

Criteria that need to be met to justify the conduct of trials in emergency situations

11

0

3

0

5

3

0

0

0

10

Other comments

Several topics, e.g. the need for more patient-oriented research

6

0

3

0

0

0

1

1

1

Total codes

748

182

73

224

130

49

6

54

30