ATTRACTIVENESS OF PRO MIXED MODES – WHAT ARE PATIENTS SAYING?
Author(s)
Ross J, Holzbaur E
Almac Clinical Technologies, Souderton, PA, USA
Presentation Documents
OBJECTIVES: An important industry topic is the utilization of mixed PRO modes in clinical trials. Using mixed modes may be beneficial for sponsors, but there is a lack of evidence supporting that data from different modes renders equivalence across modes. Given the industry’s interest in mixed modes, a qualitative research investigation was done to see if patients would be accepting if mixed modes were introduced into clinical trials. METHODS: A global internet-based survey was administered to patients who participated in at least 1 trial including patient diaries in the past 2 years. The survey included a qualitative section that asked patients to explain how attractive the option to utilize several different modes of patient diaries would be versus one mode alone in future trials. Responses were examined and placed into categories for analysis. RESULTS: CONCLUSIONS: Results show that many patients would be accepting of mixed modes, but the acceptance is not unanimous. Mixed modes may be a part of future clinical studies if equivalence evidence is established. By examining responses of those against mixed modes, patients’ concerns can be identified and addressed. Common messages identified include keeping the modes easy to use and selecting proper choice of modes for administration.
Conference/Value in Health Info
2014-05, ISPOR 2014, Palais des Congres de Montreal
Value in Health, Vol. 17, No. 3 (May 2014)
Code
PIH57
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes, Stated Preference & Patient Satisfaction
Disease
Multiple Diseases, Reproductive and Sexual Health