Table 4.
Effect of barriers on investigators' decisions to no longer conduct FDA-regulated drug trials.a
| Broad barriers and sub-barriers | Response category, n (%) |
||||
|---|---|---|---|---|---|
| Major effect | Moderate effect | Minor effect | No effect | Not applicable | |
| Time requirements, n = 30 | |||||
| Amount of time required by investigator to support trial and site staff | 11 (36.7) | 13 (43.3) | 3 (10.0) | 3 (10.0) | 0 (0) |
| Amount of time required to implement the trial | 11 (36.7) | 12 (40.0) | 5 (16.7) | 2 (6.7) | 0 (0) |
| Amount of time required to prepare for trial start-up | 15 (50.0) | 7 (23.3) | 6 (20.0) | 2 (6.7) | 0 (0) |
| Amount of time required by staff to support the trial | 9 (30.0) | 8 (26.7) | 5 (16.7) | 5 (16.7) | 3 (10.0) |
| Workload balance, n = 32 | |||||
| Long work hoursb | 12 (38.7) | 11 (35.5) | 5 (16.1) | 3 (9.7) | 0 (0) |
| Finding time to devote to activities fostering academic promotionb | 10 (32.3) | 7 (22.6) | 4 (12.9) | 6 (19.4) | 4 (12.9) |
| Finding time to devote to other work activities (non-clinical)b | 9 (29.0) | 11 (35.5) | 7 (22.6) | 4 (12.9) | 0 (0) |
| Finding time to devote to other work activities (clinical)b | 7 (22.6) | 16 (51.6) | 4 (12.9) | 4 (12.9) | 0 (0) |
| Unpredictable work hoursc | 6 (20.0) | 10 (33.3) | 7 (23.3) | 7 (23.3) | 0 (0) |
| Data and safety reporting, n = 32 | |||||
| Frequency of reporting safety datad | 9 (31.0) | 9 (31.0) | 7 (24.1) | 4 (13.8) | 0 (0) |
| Method of reporting non-safety datad | 7 (24.1) | 12 (41.4) | 6 (20.7) | 4 (13.8) | 0 (0) |
| Amount of non-safety data to reportd | 6 (20.7) | 12 (41.4) | 7 (24.1) | 4 (13.8) | 0 (0) |
| Amount of safety data to reportd | 6 (20.7) | 14 (48.3) | 5 (17.2) | 4 (13.8) | 0 (0) |
| Method of reporting safety datae | 6 (21.4) | 11 (39.3) | 6 (21.4) | 5 (17.9) | 0 (0) |
| Finance, n = 22 | |||||
| Sponsor/site budget negotiations | 7 (31.8) | 4 (18.2) | 5 (22.7) | 3 (13.6) | 3 (13.6) |
| Sponsor/site contract negotiations | 7 (31.8) | 4 (18.2) | 4 (18.2) | 4 (18.2) | 3 (13.6) |
| Final site budget | 6 (27.3) | 4 (18.2) | 5 (22.7) | 4 (18.2) | 3 (13.6) |
| Final contract | 5 (22.7) | 5 (22.7) | 4 (18.2) | 5 (22.7) | 3 (13.6) |
| Schedule of site paymentsb | 2 (9.5) | 6 (28.6) | 3 (14.3) | 6 (28.6) | 4 (19.0) |
| Study protocol and procedures, n = 20 | |||||
| Drug storage & accountability requirements | 3 (15.0) | 0 (0) | 7 (35.0) | 10 (50.0) | 0 (0) |
| Integration of study protocol procedures with standard-of-care procedures | 3 (15.0) | 4 (20.0) | 5 (25.0) | 8 (40.0) | 0 (0) |
| Study inclusion and exclusion criteria | 2 (10.0) | 5 (25.0) | 6 (30.0) | 7 (35.0) | 0 (0) |
| Recruiting patients | 2 (10.0) | 7 (35.0) | 3 (15.0) | 8 (40.0) | 0 (0) |
| Retaining patients | 1 (5.0) | 4 (20.0) | 3 (15.0) | 10 (50.0) | 2 (10.0) |
| Identifying patients | 1 (5.0) | 3 (15.0) | 8 (40.0) | 8 (40.0) | 0 (0) |
| Frequency of patient study visits | 0 (0) | 5 (25.0) | 6 (30.0) | 8 (40.0) | 1 (5.0) |
| Investigator and staff engagement and investment, n = 11 | |||||
| Lack of investigator input on protocol design | 2 (18.2) | 3 (27.3) | 2 (18.2) | 2 (18.2) | 2 (18.2) |
| Excessive training for site investigatorsb | 0 (0.0) | 2 (20.0) | 3 (30.0) | 4 (40.0) | 1 (10.0) |
| Excessive training for study staffb | 0 (0.0) | 1 (10.0) | 4 (40.0) | 4 (40.0) | 1 (10.0) |
| Limited opportunities for investigators to learn about new studiesb | 1 (10.0) | 3 (30.0) | 5 (50.0) | 1 (10.0) | 0 (0) |
| Inadequate training for investigators | 0 (0) | 4 (36.4) | 1 (9.1) | 6 (54.5) | 0 (0) |
| Inadequate training for study staff | 0 (0) | 4 (36.4) | 1 (9.1) | 6 (54.5) | 0 (0) |
a
Question only asked to investigators who indicated they decided for personal reasons to no longer conduct FDA-regulated drug trials or who indicated another reason.
b
Data missing from 1 investigator.
c
Data missing from 2 investigators.
d
Data missing from 3 investigators.
e
Data missing from 4 investigators.