Radiological clinical trials: Proposal of a problem-finding questionnaire to improve study success

Table 1 List of main issues and problems identified when conducting clinical trials¹

Problem	Score (mean ± SD) among respondents	Effect on clinical trial conduction	Suggested solution	No. of surveys scored from 19 completed surveys
Principal investigator	9 ± 0.5	Lack of team consistency and participation	The principal investigator should be PERSONALLY involved and have a pro-active approach to the study	15/19
Administrative impediments (ethics committee, insurance) affect the beginning of clinical trials	6 ± 0.37	Delay in starting the study	Employ a coordinator from administrative staff with no clinical burden	13/19
Technical problems with instruments used in the study	6 ± 0.62	Delay in conducting the study	Identify a key person to regularly check instrumentation	12/19
Insufficient willingness to be part of a team and to collaborate in the trial	7 ± 0.41	Lack of interest and enthusiasm and inability to progress or finish in time	Organise frequent investigator meetings, conference calls and study checks	15/19
Slightly different clinical practices of the involved centres	7 ± 0.42	Risk of missing or non-standardized data	Discuss and standardize practical, methodological data-related aspects of the study	14/19
Difficulties to complete a complex e-CRF	7 ± 0.46	Incomplete e-CFR and missing data	Simplify the e-CRF	17/19
Perform quantitative evaluations	8 ± 0.38	Delay in quantitative radiological data acquisition	Have dedicated trained personnel and workstations	18/19
Extra work required to comply with study inclusion criteria	9 ± 0.32	Loss of patients potentially eligible for the study	Check inclusion criteria in advance by available patient data review	18/19

¹The score system ranges from 1 (no problem) to 10 (serious problem). e-CRF: Electronic-case report form.