How to protect the study blind with unblinded site staff and monitoring.
marydrozario
Study blinding is a complex topic administratively, scientifically, psychologically and philosophically. The double-blind is the "gold standard" of clinical research, but often for reasons of persuasion and sales as much as for reasons of scientific exactitude. Meanwhile, the growing body of information and network effects available to both medical personnel and patients makes blinding more difficult than ever, and a growing variety of products, especially biologics, are more difficult to to successfully blind.
In 2009, I created a presentation for the SoCRA Annual Convention that year that was half philosophy and history overview and half administrative advice for how to protect blinding by segmenting off unblinded study staff and unblinded monitors and study management. Attached is a SoCRA Source article that I wrote after the 2009 presentation, and the current slide set from a more recent iteration of the presentation.
I think this presentation continues to be requested because dealing with complex blinding protections continues to be a footnote to clinical research administration. The textbooks from my MSCR program did not mention it, and I know of no widely used clinical research management programs for sites or sponsors which included task support for unblinded study management. Future blog posts will touch on why this might be.
The documents:
Article PDF: D'Rozario, MKD. (2011, February). Unblinded monitoring programs: Design and Education. SoCRA Source. 70-75
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Post by Mary D'Rozario originally posted to the CRP Blog.