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Table 3 The adoption of decentralised methods prior to and as a mitigation strategy for COVID-19a

From: A cross-sectional survey on the early impact of COVID-19 on the uptake of decentralised trial methods in the conduct of clinical trials

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)

  1. aNot all respondents reported on each BBB; totals do not necessarily add up to 18/15
  2. bBold indicates these decentralised methods were more often implemented as mitigation for COVID-19 compared to their use prior to COVID-19
  3. cRespondents per BBB as the proportion of total respondents; percentages for trial activities as the proportion of respondents for the specific BBB