Table 6 Adaptation of protocol procedures and in-protocol required resources to the setting
From: Increasing protocol suitability for clinical trials in sub-Saharan Africa: a mixed methods study
| Â | marginally adapted [%] | partially adapted [%] | well adapted [%] | no opinion [%] |
|---|---|---|---|---|
Informed consent procedure | 3.6 | 39.1 | 56.4 | 0.9 |
Inclusion and exclusion criteria | 3.7 | 36.7 | 58.7 | 0.9 |
Participant incentives for participation | 13.6 | 45.5 | 36.4 | 4.6 |
Recruitment procedure | 3.6 | 46.4 | 50.0 | - |
Data and information to be collected | 4.6 | 36.7 | 57.8 | 0.9 |
Medical interventions | 8.2 | 35.5 | 52.7 | 3.6 |
Medical procedures and decisions | 7.3 | 39.5 | 51.4 | 1.8 |
Safety reporting and management | 4.6 | 39.1 | 54.6 | 1.8 |
Follow-up procedure | 2.8 | 30.3 | 65.1 | 1.8 |
Amount of workforce available | 13.6 | 53.6 | 30.9 | 1.8 |
Infrastructure available | 13.8 | 48.6 | 35.8 | 1.8 |
Availability and needs of trial participants | 10.0 | 50.9 | 38.2 | 0.9 |
Daily clinical practice | 8.3 | 56.9 | 32.1 | 2.8 |
Ethics committee system | 8.2 | 46.4 | 44.6 | 0.9 |
Drug regulatory authority system | 9.1 | 42.7 | 45.5 | 2.7 |