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PROs developed de novo, using the FDA guidance may involve structured patientinterviews or focus groups. Qualitative Research is a methodology for elicitingand coding interviews and produces concepts or themes. These concepts are usedto develop items in a PRO for use as an endpoint in Clinical trials. Aconvention in the field is that interviews and code/concept elicitation areconsidered complete when subsequent interviews produces "no new concepts"-termed "saturation". FDA reviewers frequently challenge PRO developers whetherthere are sufficient patient interviews to confirm that saturation is achievedafter occurrence of zero new concepts. Several authors have reported thatconcrete criteria are need for confirming that saturation is achieved (Francis2010, Mason 2010, Marshall 2013). I provide statistical methodology forconfirming saturation, suitable for review by a regulatory authority. Type Ierror for saturation, may occur if further interviews elicited more conceptsafter first occurrence of saturation. I use published data set on codeelicitation (Guest, 2006) to demonstrate that saturation may occur more thanonce in a sequence of interviews. I provide a statistical definition forsaturation in qualitative research, that addresses regulatory concerns forPRO's developed for use as a clinical trial endpoint in a regulatorysubmission.

Pragmatic Estimation of Sample Size for Number of Interviews for PRO development in the 2009 FDA PRO guidance