Clinical Trials and Spinal Cord Injury: Challenges and Therapeutic Interventions
In SCI, like other diseases, randomized control trials (RCTs) represent the gold standard towards establishing the efficacy of novel treatments. RCTs in SCI present with their own unique set of challenges, including considerable injury heterogeneity, low numbers, variable outcome measures, and ethical concerns. Many of these challenges are compounded by difficulties in translation between animal models and the real human condition. As a consequence, current treatments to improve neurological outcomes after SCI remain limited. In this chapter, we detail many of the challenges of conducting RCTs in SCI, whilst exploring progress of several potential therapies to protect and repair nervous system tissue in humans.
XI 1: Introduction 1 1.1 Background 1 1.1.1 Childhood injuries – the New Zealand context 3 1.2 Statement of the Problem 3 1.3 Statement of Purpose 5 1.3.1 The context for the study 5 1.3.2 State research question 6 1.3.3 Study aims 6 1.4 Significance of Research 7 1.4.1 Potential benefits to childhood research 7 1.4.2 Study delimitations 8 1.5 Thesis Structure Chapter Overview 9 2: Literature Review 11 2.