BACKGROUND Newly approved, drug-modifying therapies are associated with still unknown adverse events, although clinical trials leading to approval have strict inclusion and exclusion criteria and analyse safety and efficacy. OBJECTIVES The aim of this study was to analyse the eligibility of multiple sclerosis (MS) patients treated in routine care into the phase III clinical trial of the respective drug. METHODS In total, 3577 MS patients with 4312 therapies were analysed. Patients with primary-progressive MS were excluded. Inclusion and exclusion criteria of phase III clinical trials in relapsing-remitting MS were adopted and subsequently applied. A comparison in clinical and sociodemographic characteristics was made between patient who met the criteria and those who did not. RESULTS 83% of registered patients would not have been eligible to the respective phase III clinical trial. Relapse was the single most frequent criterion not fulfilled (74.7%), followed by medication history (21.2%). CONCLUSION The majority of MS patients treated in routine care would not have met clinical trials criteria. Thus, the efficacy and safety of therapies in clinical trials can differ from those in the real world. Broader phase III inclusion criteria would increase their eligibility and contribute to a better generalizability of the results in clinical trials.

中文翻译：

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III期临床试验纳入排除标准对多发性硬化患者常规临床护理的影响

背景 新批准的药物修饰疗法与仍然未知的不良事件相关，尽管导致批准的临床试验具有严格的纳入和排除标准并分析安全性和有效性。目的 本研究的目的是分析接受常规治疗的多发性硬化症 (MS) 患者是否有资格参加相应药物的 III 期临床试验。方法 总共分析了 3577 名 MS 患者和 4312 种疗法。原发性进展型 MS 患者被排除在外。复发-缓解型 MS 的 III 期临床试验纳入和排除标准被采纳并随后应用。对符合标准的患者和不符合标准的患者进行临床和社会人口学特征的比较。结果 83% 的注册患者没有资格参加相应的 III 期临床试验。复发是未满足的最常见标准（74.7%），其次是用药史（21.2%）。结论 大多数接受常规治疗的 MS 患者不符合临床试验标准。因此，临床试验中治疗的有效性和安全性可能与现实世界中的不同。更广泛的 III 期纳入标准将提高他们的资格，并有助于临床试验结果的更好推广。临床试验中治疗的有效性和安全性可能与现实世界中的不同。更广泛的 III 期纳入标准将提高他们的资格，并有助于临床试验结果的更好推广。临床试验中治疗的有效性和安全性可能与现实世界中的不同。更广泛的 III 期纳入标准将提高他们的资格，并有助于临床试验结果的更好推广。