BBB and trial activities implementing decentralised methods | Prior to COVID-19, N respondents (%)c (n = 18 total) | As mitigation for COVID-19b, N respondents (%)c (n = 15 total) |
---|---|---|
Patient/participant engagement | 17 (94) | 10 (67) |
Social listening and patient landscape analysis | 9 (53) | 3 (30) |
Provide updates to patients throughout the trial | 7 (41) | 5 (50) |
Provide patient recruitment and retention incentives | 8 (47) | 5 (50) |
Patient concierge service | 6 (35) | 3 (30) |
Introducing behavioural incentives | 3 (18) | 3 (30) |
Patient-health care provider (HCP) interaction and communication | 6 (35) | 7 (70) |
Provide direct patient messaging | 6 (35) | 3 (30) |
Patient social community establishment | 1 (6) | 1 (10) |
Set-up and design | 13 (72) | 15 (100) |
Operational feasibility assessment | 9 (69) | 6 (40) |
Site selection/qualification | 12 (92) | 11 (73) |
Site initiation | 9 (69) | 9 (60) |
Technology set-up | 10 (77) | 6 (40) |
IMP supply | 6 (46) | 10 (67) |
Recruitment and enrolment | 15 (83) | 9 (60) |
Participant outreach | 10 (67) | 7 (78) |
Pre-screening | 11 (73) | 6 (67) |
Participant education | 10 (67) | 8 (89) |
Obtaining informed consent | 10 (67) | 4 (57) |
Screening | 5 (33) | 1 (11) |
Patient technology enablement | 6 (40) | 6 (67) |
Intervention and follow-up | 15 (83) | 14 (93) |
Self-intervention and self-monitoring | 8 (53) | 6 (43) |
Home health visits | 12 (80) | 7 (50) |
Telemedicine visits | 11 (73) | 11 (79) |
Clinic visits | 6 (40) | 7 (50) |
IMP adherence monitoring | 10 (67) | 7 (50) |
Close-out and reporting | 4 (22) | 2 (13) |
Decommissioning | 4 (100) | 2 (100) |
Archiving | 2 (50) | 2 (100) |
Data acquisition and processing | 17 (94) | 14 (93) |
Data collection | 16 (94) | 9 (64) |
Management of study-generated data | 13 (77) | 6 (43) |
Gathering and management of real-life data | 12 (67) | 6 (43) |
Clinical data repository management | 10 (59) | 6 (43) |
Data reconciliation and query management | 13 (77) | 6 (43) |
Source document verification | 7 (41) | 8 (57) |
Operations and coordination | 13 (72) | 11 (73) |
Clinical monitoring | 11 (85) | 10 (91) |
Performance monitoring | 12 (92) | 7 (64) |
Inspection facilitation | 5 (39) | 5 (46) |
System approval facilitation | 5 (39) | 4 (36) |
Safety (data) management | 12 (92) | 6 (55) |
Other trial activities | 4 (22) | 4 (27) |
Investigator payments | 1 (25) | – |
Meetings (e.g. investigator, safety, data monitoring, adjudication) | 1 (25) | 1 (25) |
Maintenance and fault checks of remote equipment | 1 (25) | – |
Patient panels and focus groups | 1 (25) | – |
Record linkage to national health and mortality databases | 1 (25) | 1 (25) |
e-signatures | – | 1 (25) |
Remote close-down of (regional) study centres | – | 1 (25) |