K. Wai, Lisa Marie Saldanha, Elvira Zenaida Lansang, Saumya Nayak, A. Sule, Ken J Lee
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引用次数: 1
摘要
通讯:Karen Wai Quintiles East Asia Pte Ltd, 79 Science Park Drive, 06-08, Cintech IV, Science Park One, 118264 Tel +65 6602 1561 Fax +65 6872 0430 Email karen.wai@quintiles.com摘要:类风湿关节炎(RA)临床试验空间竞争非常激烈,招募和留住受试者至关重要。可行性研究是确保成功征聘和留用的核心组成部分。可行性研究是对拟议研究方案的实用性进行评估,其目标是了解挑战并提供风险缓解战略,以便在评估有利的情况下更好地招募受试者和启动研究。本文介绍了对RA可行性的回顾性案例系列的研究结果,描述了在亚洲高度竞争的RA空间中需要考虑的重要参数。确定并讨论的关键参数是临床开发策略的决策如何使临床操作交付策略发生必要的变化,重点是纳入和排除标准以及患者贡献负荷的变化;当临床试验需要针对标准治疗难治性的患者群体时,患者群体有多小;管理时间;以及竞争激烈的临床试验环境。可行性评估是一项及时的工作。多个参数随着时间的推移而变化,特别是在一个对受试者具有竞争性的空间中,人们不能依靠一个静态的可行性评估来准确预测试验的效果。持续的可行性评估还将提供对赞助商、合同研究组织和调查地点的资源需求的见解。
Case series of feasibility considerations that impact operational delivery strategy in the highly competitive rheumatoid arthritis space in Asia
Correspondence: Karen Wai Quintiles East Asia Pte Ltd, 79 Science Park Drive, 06-08, Cintech IV, Science Park One, Singapore 118264 Tel +65 6602 1561 Fax +65 6872 0430 Email karen.wai@quintiles.com 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.