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Initially, strict enrolment criteria were imposed to enroll only registered drug users [ 27].
Using strict enrolment and assessment criteria, only 15.3% of SSc patients with active interstitial lung disease could be classified as improved after 6 months of treatment with low-dose imatinib.
The strict enrolment criteria for entry into clinical trials may cause underrepresentation of elderly people and may exclude them from more aggressive treatment strategies because of the side effects of the therapy on physical frailty, comorbidity, and polypharmacy (Koppie et al, 2008).
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The spill over effect was and continues to be further contained by the strict control on enrolment procedure which can be secured thanks to the availability of DSS data.
The criteria for enrolment are strict and well-defined, necessitating the screening of large numbers of individuals for each subject enrolled.
The strict application of the enrolment criteria has made possible to use a standardized treatment regimen throughout the country.
These include the use of relatively broad enrolment criteria instead of strict patient selection [ 4], covariate adjustment for baseline patient characteristics [ 5], and ordinal rather than dichotomous outcome analysis [ 6].
It is no surprise, therefore, that the British Council's Shape of International Education to 2025 report cites the UK as an example of a popular destination country that is experiencing decreased international student enrolment as a result of stricter visa regulations.
In future research this exclusion criteria can be formulated less strict, which will probably result in a greater enrolment.
Despite the strict inclusion criteria, which may have led to enrolment bias, similar findings have been described in other studies [ 69, 71, 78, 82].
Furthermore, patient enrolment was not performed according to a strict protocol as in a prospective trial but at the discretion of the attending physician.
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