Research Article

Using Electronic Health Records to Support Clinical Trials: A Report on Stakeholder Engagement for EHR4CR

Table 6

Motivators and threats for participation in EHR4CR.

Use of existing national datasets of deidentified data

Do you think that out-licensing from your institution (or from an institution in your country if you are not based in a healthcare institution) of a large body of detailed pseudoanonymised longitudinal secondary care (hospital) data to an organisation conducting research into postmarketing drug safety would:YesNoDo not know
(a) Require prior patient level consent?22 (59)14 (38)0
(b) Be likely to receive institutional approval?22 (59)6 (16)8 (22)
(c) Raise significant ethical/information security concerns?21 (57)14 (38)1 (3)
(d) Require data protection authority or another regulatory external body approval?26 (70)5 (14)4 (11)

Other aspects

Indicate your agreement/disagreement with the following as strong motivating factors for your institution’s participation in the EHR4CR platform (now or in the future). If you are not based in a healthcare institution, consider these factors for an institution in your country.Strongly AgreeAgreeNeitherDisagreeStrongly Disagree
Increased income generation from participation in more industry trials6 (16)20 (54)1 (3)5 (14)4 (11)
Pressure from government or institution to participate in more pharma industry studies6 (16)8 (22)8 (22)11 (30)3 (8)
Providing patients with faster access to new generation medicines10 (27)17 (46)4 (11)3 (8)2 (5)
Development of local health information systems8 (22)19 (51)6 (16)1 (3)2 (5)
Improvement of local data quality and healthcare14 (38)15 (41)3 (8)3 (8)1 (3)
The potential to use EHR4CR platform to conduct academic studies13 (35)18 (49)3 (8)1 (3)0
Opportunity to improve the quality of data in clinical trials12 (32)17 (46)3 (8)3 (8)1 (3)
Opportunity to improve the efficiency of clinical trials11 (30)20 (54)5 (14)00

Indicate your agreement/disagreement with the following as significant threats in your institution or country to the success of EHR4CR.

Inadequate availability of key data fields in the patient record6 (16)16 (43)6 (16)6 (16)3 (8)
Missing data in the patient record6 (16)17 (46)7 (19)7 (19)0
Inadequacy of local health information systems6 (16)16 (43)2 (5)10 (27)2 (5)
Cost of upgrading local systems to be compatible with EHR4CR12 (32)10 (27)9 (24)6 (16)0
Ethical committee concerns3 (8)18 (49)4 (11)11 (30)1 (3)
Local information governance concerns5 (14)19 (51)4 (11)9 (24)0
Data protection authorities4 (11)17 (46)5 (14)7 (19)2 (5)
Concerns of hospital management2 (5)13 (35)8 (22)13 (35)1 (3)
Concerns of patients3 (8)11 (30)5 (14)16 (43)2 (5)
Concerns of clinicians013 (35)5 (14)16 (43)3 (8)