Table 4.
Difficulties in clinical research by study characteristicsa
| Study characteristics | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Privatebsponsorship | Public sponsorship | Multi center | Single center | Otherc | Clinicald | ||||
| Difficulties with: | % | % | p | % | % | p | % | % | p |
| Literature review (get relevant articles, read, synthesize) | 2.4 | 6.9 | 0.19 | 3.1 | 7.9 | 0.078 | 7.2 | 4.9 | 0.39 |
| Research question (formulation of a main research question and/or hypothesis) | 1.2 | 13.1 | 0.001 | 3.2 | 15.0 | <0.001 | 15.1 | 5.9 | 0.004 |
| Study design (identification of the study design, variables, instruments, analysis, including calculation of the sample size) | 2.4 | 25.8 | <0.001 | 8.2 | 29.1 | <0.001 | 23.3 | 18.0 | 0.21 |
| Approval by the Research Ethics Committee | 12.2 | 17.9 | 0.25 | 11.9 | 20.3 | 0.038 | 12.8 | 20.4 | 0.056 |
| Getting funding | 3.7 | 23.9 | <0.001 | 13.8 | 23.1 | 0.026 | 19.0 | 19.5 | 1.00 |
| Approval by the safety agencies (Swiss Agency for Therapeutic Products, etc.) | 17.3 | 8.3 | 0.023 | 14.6 | 7.0 | 0.024 | 3.9 | 15.7 | <0.001 |
| Patients enrollment | 51.3 | 41.5 | 0.13 | 48.1 | 42.5 | 0.30 | 37.1 | 51.5 | 0.005 |
| Data collection | 19.5 | 28.9 | 0.12 | 22.0 | 30.0 | 0.10 | 26.1 | 27.2 | 0.82 |
| Collaboration with caregivers for patient enrollment | 18.3 | 22.1 | 0.54 | 20.1 | 21.8 | 0.80 | 19.4 | 22.5 | 0.53 |
| Recruitment of competent persons to conduct the study | 12.2 | 22.0 | 0.059 | 16.4 | 22.9 | 0.12 | 16.7 | 23.3 | 0.13 |
| Data management | 6.1 | 20.4 | 0.002 | 10.1 | 21.8 | 0.002 | 19.6 | 14.6 | 0.22 |
| Data analysis (statistical or other) and results interpretation | 3.7 | 26.7 | <0.001 | 10.8 | 29.3 | <0.001 | 23.5 | 20.1 | 0.46 |
| Writing a manuscript for a scientific publication | 1.2 | 23.8 | <0.001 | 8.9 | 25.6 | <0.001 | 20.9 | 16.7 | 0.36 |
| Publication in a peer-reviewed journal | 4.9 | 25.5 | <0.001 | 14.6 | 24.8 | 0.020 | 21.1 | 20.0 | 0.80 |
| Other(s) difficulty(ies) | 3.7 | 5.8 | 0.58 | 5.0 | 5.3 | 1.00 | 8.9 | 1.9 | 0.002 |
aSelected from the multivariable model (Table 3). P-values come from the Fisher’s exact test
bIndustry or foundation
cHealth/illness, public health, methodology, etc
dIntervention or diagnosis or prognosis