Table 2.
List of identified items for study-level feasibility assessment of clinical trials
| Domain | Items | Number of checklists, total = 10 [References] |
|---|---|---|
| 1. Regulation, review and oversight | The clinical trial is compliant with local regulations | 7 [5, 17–19, 21, 23, 25] |
| The study protocol has been (independently) peer reviewed | 2 [21, 23] | |
| Safety aspects are accommodated | 3 [20, 21, 23] | |
| 2. Participant recruitment | The target population is available | 8 [5, 17, 18, 20–23, 25] |
| Competing trials are known | 7 [5, 17, 18, 21, 23–25] | |
| A recruitment rate is estimated | 6 [18, 19, 21–24] | |
| Factors that hinder/have an impact on recruitment are known | 5 [5, 21, 23–25] | |
| The target sample size to recruit is known | 5 [5, 18, 19, 21, 22] | |
| The study is interesting to others (e.g. physicians, co-investigators) | 5 [5, 18, 20, 21, 24] | |
| Strategies and resources that are needed for recruitment are known | 4 [5, 17, 21, 24] | |
| Routine data sources corroborate estimated recruitment rate or can facilitate recruitment | 4 [5, 17, 23, 24] | |
| Eligibility criteria are clear and realistic | 3 [17, 18, 25] | |
| Other sites are available, if necessary | 3 [17, 24, 25] | |
| Organisations and groups, relevant to recruitment, are known | 2 [5, 24] | |
| How the target sample size was calculated is known | 2 [5, 21] | |
| The necessary number of sites is known | 2 [17, 19] | |
| The estimated recruitment rate(s) is/are reasonable | 1 [23] | |
| 3. Space, material and equipment | Access to professional support and required facilities is available | 8 [5, 17–19, 21, 22, 24, 25] |
| Equipment is appropriate and sufficient | 8 [5, 17–20, 22, 24, 25] | |
| Working space is appropriate and sufficient to conduct the study | 6 [5, 17, 19, 21, 24, 25] | |
| Study drug and comparator are available | 7 [17–21, 24, 25] | |
| Storage room for study material is appropriate and sufficient | 5 [5, 17, 19, 21, 25] | |
| Secure storage room for study or patient documents/ recorded data is sufficient | 6 [5, 17, 19–21, 25] | |
| Access to relevant electronic systems are available | 5 [5, 18–21] | |
| 4. Financial resources | The budget is adequate | 6 [17, 18, 20, 21, 23, 25] |
| Excess costs at sites are accommodated | 3 [5, 21, 24] | |
| The budget for recruitment and follow-up visits is adequate | 1 [19] | |
| 5. Trial team resources | Adequate staffing is identified and available within the trial period | 8 [5, 17–21, 24, 25] |
| Investigator / study team has time for study visits | 5 [5, 17, 20, 21, 24, 25] | |
| Investigator has time to complete the study | 4 [5, 21, 24, 25] | |
| Training for staff is available | 4 [5, 18, 21, 24] | |
| Investigator has appropriate experience | 3 [21, 24, 25] | |
| Investigator has time to supervise the trial team | 4 [17, 20, 24, 25] | |
| Investigator has time to check the data | 2 [17, 25] | |
| Investigator has time to interact with the sponsor | 2 [17, 25] | |
| Work out of hours is accommodated | 2 [5, 21] | |
| Investigator has capacity to recruit the patients | 1 [25] | |
| 6. Trial management | Current standard of practice at trial site is compatible with trial protocol | 8 [5, 17, 18, 20–24] |
| The study schedule is reasonable | 4 [17, 18, 22, 25] | |
| Specific patient related aspects are accommodated (e.g. children) | 3 [21, 23, 24] | |
| The methods for site selection are known | 3 [5, 20, 24] | |
| Project management considerations were made | 2 [5, 19] | |
| Special vendor requirements are known | 2 [18, 21] | |
| On-site management is available | 1[19] | |
| Clinical care for trial participants is coordinated and managed | 1 [24] | |
| Assessment of outcomes is accommodated at sites | 1 [24] | |
| 7. Pilot or feasibility studies | A pilot study was conducted | 2 [5, 24] |
| All sites were included in the feasibility studies | 1 [24] |