Using Electronic Health Records to Support Clinical Trials: A Report on Stakeholder Engagement for EHR4CR
Table 2
Use of the EHR4CR platform for trial feasibility.
Scenario
A
B
C
D
Do you think that data transfer would require previous informed consent by patients for the use of their data in this manner?
Yes
7 (19)
10 (27)
25 (68)
29 (78)
No
30 (81)
26 (70)
8 (22)
5 (14)
Do not know
0
1 (3)
3 (8)
3 (8)
Do you think that data transfer would be approved by your institution (or an institution in your country if you are not based in a healthcare institution)/by an ethics committee in your country?
Yes
30 (81)
26 (70)
16 (43)
12 (32)
No
3 (8)
5 (14)
9 (24)
15 (41)
DK
1 (3)
2 (5)
8 (22)
6 (16)
Do you think that the transfer of these data would create ethical/information governance concerns at your institution (or an institution in your country if you are not based in a healthcare institution)?
Yes
7 (21)
7 (21)
22 (65)
29 (85)
No
25 (74)
22 (65)
7 (21)
2 (6)
DK
1 (3)
4 (12)
4 (12)
2 (6)
Strongly Agree
Agree
Neither
Disagree
Strongly Disagree
Indicate your agreement/disagreement with the statement that “this approach to facilitating feasibility assessment would enhance the conduct of clinical trials.”
0
3 (100)
0
0
0
Indicate your agreement/disagreement with the statement that “providing data to an organisation conducting clinical research or trusted third party in such an automated manner would reduce workloads and save time of healthcare institution employees.”
8 (24)
16 (47)
6 (18)
4 (12)
0
Scenario A: total number of patients meeting all criteria only returned to sponsor.
Scenario B: number of patients meeting each criterion returned to sponsor.
Scenario C: number of patients meeting each criterion returned to 3rd party.
Scenario D: deidentified patient records meeting criteria returned to sponsor.
