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Response to Rickels Letter

To the Editor: We thank Dr. Rickels for reminding us of his early and important work in this area, which further highlights the porousness of the double-blind study. Indeed, as we pointed out, some of these concepts date back more than 25 years. In a previous draft of our commentary, we remarked on the curious point that such concepts seem to be rediscovered every decade or so.

Dr. Rickels also asserts his belief that alternative strategies, such as multiple raters or active placebos, will not be effective in preserving the blind. Certainly, one size does not fit all in a clinical trial design. However, given that existing trial design guidelines advocate these strategies, we might hope for an empirical study before dismissing them out of hand.

Boston, Mass.

accepted for publication in May 2010.

The author's disclosures accompany the original commentary.

References

1. International Conference of Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: ICH Harmonised Tripartite Guideline: Choice of Control Group and Related Issues in Clinical Trials (E10). Geneva, Switzerland, 2000. http://www.ich.org/LOB/media/MEDIA486.pdfGoogle Scholar