Patients Involved – Advisory boards on psoriasis clinical trials

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Introduction

Novartis Advisory Board meets with six National Psoriasis Patient Organisations to address patient relevant endpoints in psoriasis clinical trials.

 

When does it happen? – Phase III

Description of the case

Novartis Advisory Board with Patient Organisations to address patient relevant endpoints in psoriasis clinical trials involved six National Psoriasis Patient Organisations representatives (Germany, Italy, France, Spain, Sweden and Switzerland) to discuss patient relevant endpoints in psoriasis clinical trials.

Type(s) of patient (advocates) involved

• Patients with personal disease experience.
• Expert patient / patient advocate with good expertise on disease but little R&D experience.
• Expert patient / patient advocate with good expertise on disease and good R&D experience.

Benefits of patient involvement

• Patient relevant endpoints identified e.g. quality of life as primary secondary endpoint, efficacy and safety long term, rapidity for young patients.
• Psoriasis Area Severity Index (PASI) is not relevant for patients, important is location of plaques.
• Patient friendly materials and trained nurses to support treatment self-administration, compliance and trial participants’ awareness of concomitant therapies are requested.

Challenges and barriers

Find expert advocates with a specific knowledge in clinical trials.

Learnings

• Earlier start (Phase II and protocol design phase).
• Multi-stakeholders Advisory Board (with Key Opinion Leaders and/or payers)

A3-advisory-board-on-Psoriasis-clinical-trials_V1.0

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