Table 2 Major barriers to the conduct of randomized trials identified by systematic reviews
Major barriers to the conduct of randomized trials | Source |
Inadequate funding | Duley et al. (2008) [1], Djurisic et al. (2017) [2], Alemayehu et al. (2018) [4] |
Complex/not harmonized regulations | Duley et al. (2008) [1], Djurisic et al. (2017) [2], Alemayehu et al. (2018) [4] |
Excessive/non-focused monitoring | |
Over-restrictive interpretations of privacy laws without evidence of subject benefit/Lack of transparency | |
Inadequate understanding of methodology | Duley et al. (2008) [1] |
Inadequate identification of the clinical research questions | Djurisic et al. (2017) [2] |
Inadequate knowledge and understanding of clinical research | Djurisic et al. (2017) [2] |
Inadequate knowledge and understanding of clinical trials | Djurisic et al. (2017) [2] |
Inadequate infrastructures | |
Unsupportive administrative system | Alemayehu et al. (2018) [4] |
Competing demands | Alemayehu et al. (2018) [4] |
Difficult patient recruitment | Alemayehu et al. (2018) [4] |
Major barriers to the conduct of RCTs in rare diseases | Source |
Difficult to recruit patients due to rarity | Rath et al. (2017) [3] |
Incomplete understanding of national history to inform trial design | Rath et al. (2017) [3] |
Need for trial designs adapted to small population size and clinical heterogeneity | Rath et al. (2017) [3] |
Organizational challenges as a consequence from the need for multinational randomized clinical trials | Rath et al. (2017) [3] |
Need for more sensitive outcome measures to quantify disease | Rath et al. (2017) [3] |
Need for involvement of all the stakeholders in the study design and conduct | Rath et al. (2017) [3] |