Department of Research, MS Society UK, London, UK.
Research Network, MS Society UK, London, UK.
Mult Scler. 2023 Aug;29(9):1162-1173. doi: 10.1177/13524585231189678.
Although often overlooked, patient and public involvement (PPI) is vital when considering the design and delivery of complex and adaptive clinical trial designs for chronic health conditions such as multiple sclerosis (MS).
We conducted a rapid review to assess current status of PPI in the design and conduct of clinical trials in MS over the last 5 years. We provide a case study describing PPI in the development of a platform clinical trial in progressive MS.
We identified only eight unique clinical trials that described PPI as part of articles or protocols; nearly, all were linked with funders who encourage or mandate PPI in health research. The OCTOPUS trial was co-designed with people affected by MS. They were central to every aspect from forming part of a governance group shaping the direction and strategy, to the working groups for treatment selection, trial design and delivery. They led the PPI strategy which enabled a more accessible, acceptable and inclusive design.
Active, meaningful PPI in clinical trial design increases the quality and relevance of studies and the likelihood of impact for the patient community. We offer recommendations for enhancing PPI in future MS clinical trials.
尽管常常被忽视，但在考虑设计和实施针对多发性硬化症（MS）等慢性健康状况的复杂和适应性临床试验时，患者和公众参与（PPI）至关重要。
我们进行了快速审查，以评估过去 5 年来 PPI 在 MS 临床试验设计和实施中的现状。我们提供了一个案例研究，描述了 PPI 在进展性 MS 平台临床试验开发中的应用。
我们仅确定了八项独特的临床试验，这些试验将 PPI 作为文章或方案的一部分进行描述；几乎所有临床试验都与鼓励或要求在健康研究中进行 PPI 的资助者有关。OCTOPUS 试验是与受 MS 影响的人共同设计的。他们从治理小组的形成到治疗选择、试验设计和交付的工作组，都对每个方面发挥了核心作用。他们领导了 PPI 战略，使设计更具可及性、可接受性和包容性。
在临床试验设计中积极、有意义的 PPI 可以提高研究的质量和相关性，以及对患者群体的影响可能性。我们为未来的 MS 临床试验中的 PPI 提供了建议。
