Case series of feasibility considerations that impact operational delivery strategy in the highly competitive rheumatoid arthritis space in Asia

Karen Wai,¹ Lisa Marie Saldanha,¹ Elvira Zenaida Lansang,¹ Saumya Nayak,¹ Anish Sule,² Ken J Lee<sup>3

1</sup>Feasibility and Site Identification Asia, Quintiles East Asia Pte Ltd, Singapore; ²Feasibility and Site Identification India, Quintiles India, Mumbai, India; ³Site Services Asia, Quintiles East Asia Pte Ltd, Singapore

Abstract: The rheumatoid arthritis (RA) clinical trial space is very competitive, and recruiting and retaining subjects is of critical importance. Feasibility studies are a central component of ensuring successful recruitment and retention. A feasibility study is an assessment of the practicality of a proposed study protocol, with the goal of understanding challenges and providing risk mitigation strategies leading to better subject enrolment and study start-up should the assessment be favorable. This paper presents findings from a retrospective case series of RA feasibilities, describing important parameters to consider in the highly competitive RA space in Asia. Key parameters identified and discussed are how decisions on clinical development strategy necessitate changes in the clinical operational delivery strategy, with focus on changes in inclusion and exclusion criteria and patient contribution load; how small the patient population becomes when the clinical trial needs to target the patient population that is refractory to standard therapy; regulatory timelines; and the competitive clinical trial landscape. Feasibility assessments are a snapshot in time exercise. Multiple parameters change over time, and, particularly in a space that has become competitive for subjects, one cannot rely on one static feasibility assessment to predict trial performance accurately. Continuous feasibility assessment will also provide insight into the resourcing needs on the part of the sponsor, contract research organization, and investigative site.

Keywords: site selection, country selection, clinical operations, risk management, recruitment rates