Where trial design was changed, pre-trial testing led to an arm of the trial being dropped in three cases.
3 Furthermore, any strategies to reduce the potential for unblinding should be described in the protocol, such as pre-trial testing of blinding procedures.
The initial phone survey developed by the research team had 159 questions and in pre-trial testing took 30 minutes to complete.
If funders were more receptive to supporting, or even insisted upon, comprehensive pre-trial testing it is reasonable to believe that fewer suboptimal complex interventions would enter full-scale trials.
We limited ourselves to these seven journals because we thought it would be unwise to commit resources to a systematic review without having a much better idea of the type and extent of pre-trial testing done in complex intervention studies.
Fish showed no signs of adverse reaction to this Daphnia delivery method during pre-trial tests, and startle responses to the Daphnia delivery during silent control trials were rare (see Figure 4a).
The results of pre-trial potency testing revealed that both FP9 and MVA ME-TRAP were as immunogenic as expected based on previous assays of these vaccines, producing on ELISPOT a mean number of 125 spot forming units (sfu) per 106 splenocytes (standard deviation, SD 59.7), and 554 splenocytesenocyteSD(SD 118) respectively (mean of results from 4 individual mice for each vaccine).
The device was conceived by JF, developed in conjunction with KB, and prototype models were produced by a product design and development consultancy, which completed pre-trial laboratory testing.
In the absence of RCTs, other research designs - non-randomised controlled trials, pre-test-post-test studies, cohort studies, case-control studies, and descriptive studies - were considered for inclusion.
Thus, the 8-color ICS assay was formally qualified according to the ICH guidelines Q2 (R1) for specificity and precision indicating that it is considered a standardized/robust assay acceptable for use in pre-clinical trial immunogenicity testing.
* The difference in proportion of the number of women tested for chlamydia in the pre-trial and trial periods.
