Using Electronic Health Records to Support Clinical Trials: A Report on Stakeholder Engagement for EHR4CR
Table 5
Use of the EHR4CR platform for adverse event reporting.
Scenario
H
I
J
Do you think that this scenario would be accepted by your institution (or an institution in your country if you are not based in a healthcare institution)?/do you think that this scenario would be approved by an ethics committee in your country?
Yes No DK
19 (51) 9 (24) 7 (19)
26 (70) 4 (11) 5 (14)
22 (59) 4 (11) 7 (19)
Do you think that this scenario would create ethical/information governance concerns at your institution (or an institution in your country if you are not based in a health care institution)?
Yes
17 (50)
8 (24)
12 (32)
No
16 (47)
22 (65)
21 (57)
DK
0
3 (9)
2 (5)
Indicate your agreement/disagreement with the statement that “accumulating adverse event reports in this manner will significantly improve the reporting of adverse drug reactions during clinical trials”/indicate your agreement/disagreement with the statement that “this approach to facilitating adverse event reporting would enhance the evaluation of the safety of medicines.”
Strongly Agree
7 (19)
15 (41)
8 (22)
Agree
18 (49)
16 (43)
17 (46)
Neither
10 (27)
4 (11)
7 (19)
Disagree
1 (3)
0
4 (11)
Strongly Disagree
1 (3)
1 (3)
0
Indicate whether you think that this scenario would require previous informed consent by patients for the use of their data.
Yes
17 (46)
12 (32)
No
15 (41)
21 (57)
DK
3 (8)
2 (5)
Scenario H: individual patient level data on adverse events returned to organisation conducting research. Scenario I: individual patient level data on adverse events returned to local clinician to prepare report for regulatory authorities. Scenario J: periodic aggregated data on adverse events reported turned to regulatory authorities.
