We would like to thank the authors of the FIRST trial for responding to our paper on 'Ethical implications of excessive cluster sizes in cluster randomised trials'.1 We are pleased that our paper has generated this interest. The science and methodology of trial design are constantly evolving and will evolve faster, to the future benefit of science, if we can openly reflect on how things have been done in the past and how we might do things differently in the future. We used the FIRST trial as a case study in our analysis as we believed it demonstrated potential for a more efficient design.
The FIRST authors make some valid points about pragmatic trials and large cluster sizes, that being that there are multiple factors to consider when designing trials. However, generalisability refers to the replication of the study results across different populations. Very large trials in...
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