The depression working group at Critical Path Institute’s (C-Path) Patient-Reported Outcome (PRO) consortium

Author

Steven I. Blum, MBA, MA, Forest Research Institute, Inc., Jersey City, NJ, USA and Cochair of the PRO Consortium’s Depression Working Group (on behalf of the Depression Working Group)

The Depression Working Group (DWG) is one of seven PRO Consortium working groups. The DWG’s objective is to obtain FDA qualification of a patient-reported measure of major depressive disorder (MDD) symptoms for use as a primary endpoint measure in MDD clinical trials to support product labeling.

The DWG is composed of representatives from nine member firms (AbbVie, Bristol-Myers Squibb, Eli Lilly, Forest, Janssen, Pfizer, Shire, Sunovion, and Takeda), C-Path staff, and representatives from Health Research Associates, Inc. The DWG has also engaged a panel of experts to provide clinical input at key points during the research process.
Initial work consisted of a focused literature review of prior patient centered qualitative research and a detailed assessment of existing MDD assessment tools, both of which helped to inform the concept elicitation interviews. Individual interviews were conducted by trained research staff using a semistructured interview guide designed to elicit both spontaneous and probed responses. By leveraging the existing literature, clinician input, and the patient interview data, the DWG identified the most clinically relevant symptom concepts and decided to develop a new PRO measure rather than to seek qualification of an existing measure.

Draft items were developed and subsequently debriefed during three rounds of cognitive interviews. In parallel with the cognitive interviews, a translatability assessment was performed to ensure that the instrument and draft items could be easily adapted, both linguistically and culturally, for use in global studies. An electronic implementation assessment was conducted by C-Path’s ePRO Consortium to identify potential challenges in migration of the instrument to various electronic data-collection platforms. The preliminary version of the measure, the Symptoms of Major Depressive Disorder Scale (SMDDS), includes 35-items covering 11 domains. A briefing document detailing this initial development of the SMDDS has been submitted to the FDA for review by the Qualification Review Team. Quantitative research is planned to examine item function, assess test-retest reliability, evaluate cross sectional construct validity, and further refine the SMDDS prior to submission for FDA qualification.