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.
Mapi Research Trust, Lyon, France
Extending our PROLabels Coverage
As of August 2013, 675 drug approvals (also including biological products and vaccines), representing over 370 different molecules, have been approved with the use of PRO endpoints to demonstrate the efficacy of the treatment and the benefit from the patient’s perspective, at the EMA and the FDA. The PRO labeling claims, including the method of measure of the PRO, are fully described in PROLabels (www.prolabels.org).
New Instruments with PRO Claims
Among the wide range of different measures used to obtain the PRO labeling claims described in PROLabels, we can cite PRO questionnaires. To date, PROLabels contains 134 of them, and five have been added since the last listing in June 2012. (See Table 1)
PROLabels and PROQOLID work hand in hand to provide the best information exchange in health outcomes
When the author of an instrument concurs, we include a description of the instrument in PROQOLID and make a link from the PROLabels product sheet to the instrument’s dedicated webpage on the PROQOLID database. Likewise, there is a link from the instrument’s PROQOLID description sheet to our PROLabels site.
List of instruments recently added to PROLabels
- OAB-q (Link to PROQOLID: Overactive Bladder symptom and health-related quality-of-life questionnaire)
- PBAC (Pictorial blood-loss assessment chart)
- PDSS (Link to PROQOLID: Parkinson’s Disease Sleep Scale)
- PedsQL (Link to PROQOLID:
- Pediatric Quality-of-Life Inventory™)
- PUQE (Pregnancy-Unique Quantification of Emesis)