Table 1.
Summary of responses to the survey provided by the five early phase clinical trials units
| Items | Total, n | Total, %** |
|---|---|---|
| Baseline data* | ||
| Phase I trials active, recruiting | 27 | |
| Phase II trials active, recruiting | 57 | |
| Molecular platforms active, recruiting | 2 | |
| Total phase I–II trials or molecular platforms active, recruiting | 86 | |
| H Vall d’Hebron | 25 | |
| H Sant Joan de Deu | 8 | |
| H La Fe | 18 | |
| H La Paz | 9 | |
| H Niño Jesús | 26 | |
| Phase I trials active, not yet recruiting | 8 | |
| Phase II trials active, not yet recruiting | 8 | |
| SIV previously scheduled for March/April 2020 | 10 | |
| MV previously scheduled for March/April 2020 | 49 | |
| Unit’s full-time workers | 73 | |
| Total of patients recruited in Phase I/II studies during 2019 | 98 | |
| Impact on personnel | ||
| Number of units suffering shortages of on-site staff | 5 | 100% (5/5) |
| Total reduction in number of on-site workers | 43 | 59% (43/73) |
| Cause of personnel reduction: | ||
| COVID-19-infected workers | 3 | 7% (3/43) |
| Institutional contingency policy (i.e., home-based work) | 38 | 88% (38/43) |
| Relocation to other areas to work on COVID-19 | 2 | 5% (2/43) |
| Units performing remote data entry | 5 | 100% (5/5) |
| Units with appropriate tools for homeworking | 3 | 60% (3/5) |
| Impact on on-site activities performed by the sponsors | ||
| Units suffering SIV delays/cancellation | 4 | 80% (4/5) |
| Number of SIV postponed | 7 | 70% (7/10) |
| Postponing SIV decided by: | ||
| Sponsor | 7 | 100% (7/7) |
| Investigators | 0 | 0% |
| Institution | 0 | 0% |
| Number of SIV performed remotely | 3 | 30% (3/10) |
| Units suffering MV delays/cancellation | 5 | 100% (5/5) |
| Number of MV postponed | 36 | 73% (36/49) |
| Postponing MV decided by: | ||
| Institution | 25 | 70% (25/36) |
| Investigators | 0 | 0% |
| Sponsor + Institution | 11 | 30% (11/36) |
| Number of MV performed remotely | 13 | 27% |
| Impact on recruitment | ||
| Units continuing recruitment | 4 | 80% (4/5) |
| Units with restrictions to accept new referrals | 4 | 80% (4/5) |
| New patients recruited to early phase trials*** | 2 | |
| Trials with recruitment stopped | ||
| H Vall d’Hebron | 6 | 24% (6/25) |
| H Sant Joan de Deu | 6 | 75% (6/8) |
| H La Fe | 18 | 100% (18/18) |
| H La Paz | 2 | 22% (2/9) |
| H Niño Jesús | 6 | 23% (6/26) |
| Recruitment stop decided by: | ||
| Sponsor | 18 | 47% (18/38) |
| Investigators | 0 | 0% |
| Institution | 20 | 53% (20/38) |
| Impact on IMP and research devices | ||
| Trials with IMP shortages | 0 | 0% |
| Units shipping IMPs to the patient’s home or to the local healthcare institution | 2 | 40% (2/5) |
| Trials in which IMP were shipped to the patient’s home or to the local healthcare centres | 6 | 7% (6/84) |
| Units in which the sponsor facilitated the shipment of IMP to patients | 5 | 100% (5/5) |
| Units managing to increase IMP supplies to patients | 3 | 60% (3/5) |
| Trials managing to increase IMP supplies to patients | 15 | 18% (15/84) |
| Trials suffering shortages of research devices (e.g., sample kits) | 0 | 0% |
| Units with difficulties to send out research samples | 0 | 0% |
| Impact on patient care organization | ||
| Units suffering restrictions to treat patients | 5 | 100% (5/5) |
| Total number of patient visits conducted | 143 | |
| Patient visits conducted on-site | 110 | 77% (110/143) |
| Patient visits conducted in other healthcare facilities | 13 | 9% (13/143) |
| Patient visits conducted by phone | 20 | 14% (20/143) |
| Patient visits rescheduled | 14 | 10% (14/143) |
| Patient visits cancelled | 0 | 0% |
| Units which received sponsor’s agreement to conduct patient visits in other health care institutions | 5 | 100% (5/5) |
| Patients suffering treatment delays | 1 | |
| Cause for patients suffering treatment delay: | ||
| Not possible to ensure IMP supply | 0 | 0% |
| Not possible to ensure safety | 0 | 0% |
| Patient/parents’ decision | 1 | 100% (1/1) |
| Patients suffering treatment discontinuation | 0 | |
| Units suffering restriction to perform trial assessments | 2 | 40% (2/5) |
| Patients not being able to be recruited into potential trials | 7 | |
| Alternative provided to patients not being able to be recruited into trials | ||
| No treatment | 3 | 43% (3/7) |
| Out-of-trial treatment | 4 | 57% (4/7) |
| Inclusion in a trial elsewhere | 0 | |
| Decision not to include patients taken by: | ||
| Sponsor | 3 | 43% (3/7) |
| Investigators | 4 | 57% (4/7) |
| Institution | 0 | 0% |
| Patient/parents | 0 | 0% |
| Impact on legal aspects | ||
| Pending contracts postponed | 3 | |
| Units approached with sponsor contingency plans for the management of issues related to the COVID-19 crisis | 5 | 100% (5/5) |
| Units creating individual contingency plans for the management of issues related to the COVID-19 crisis | 5 | 100% (5/5) |
| Future perspectives | ||
| Unit Leads expecting lower recruitment rates in 2020 compared to 2019 | 5 | 100% (5/5) |
| Unit Leads planning changes in organization for the next months to promote home working and remote MVs or SIVs | 4 | 80% (4/5) |
| Unit Leads thinking this crisis will make them better prepared for future crises | 5 | 100% (5/5) |