CIDP: Development of a PRO Strategy
Research type
Research Study
Full title
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): Development of a PRO Strategy
IRAS ID
202812
Contact name
Stefan Cano
Contact email
Sponsor organisation
UCB Biopharma Sprl,
Duration of Study in the UK
0 years, 8 months, 1 days
Research summary
UCB Biopharma Sprl, a pharmaceutical company is considering drug development for several rare autoimmune diseases, including chronic inflammatory demyelinating polyneuropathy (CIDP). UCB wishes to explore CIDP symptoms and daily impact from the patient’s perspective, and to use this information in the assessment of new treatments. UCB has commissioned Modus Outcomes, an independent outcomes research and consulting firm to conduct a research study and address this goal. The proposed study has been designed to investigate the range of symptoms experienced by adult CIDP patients and the spectrum of daily impact of CIDP with the aim of conceptualising “treatment benefit” in CIDP.
Trained Modus Outcomes interviewer (Dr Sophie Cleanthous) will conduct two rounds of telephone interviews with a total of 60 people living with CIDP. Interviews will last approximately 60 minutes and will be audio-taped. NO personal information about participants will be shared with the pharmaceutical company.
The first round of interviews will be exploratory, aiming to elicit the concepts important to patients in relation to their condition. Qualitative analysis will be used to map out aspects of treatment benefit in CIDP (including symptoms and general impact and function) and generate items which can be used at a later stage for the assessment of treatment benefit in CIDP (i.e. items that can later be used in a questionnaire). The second round of interviews will be semi-structured aiming to assess the comprehensiveness of the ”treatment benefit” conceptual framework and to cognitively debrief the newly generated items produced by the analysis of the first round interviews.
This study will enhance knowledge of CIDP, highlighting concepts which are most important to patients, and will further propose a treatment benefit conceptual framework and draft item stems which could form the basis for the assessment of treatments in CIDP.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
16/EM/0104
Date of REC Opinion
15 Mar 2016
REC opinion
Further Information Favourable Opinion