Factors determining placebo response in drug-resistant focal epilepsy
决定耐药局灶性癫痫安慰剂反应的因素
基本信息
- 批准号:8670039
- 负责人:
- 金额:$ 8.39万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2013
- 资助国家:美国
- 起止时间:2013-06-15 至 2016-05-30
- 项目状态:已结题
- 来源:
- 关键词:AdultAdverse eventAffectAgreementAntiepileptic AgentsCategoriesCharacteristicsChildClinical TreatmentClinical TrialsClinical Trials DesignCollaborationsConduct Clinical TrialsDataDrug Approval ProcessesDrug resistanceEnrollmentEpilepsyFailureGoalsGoldIndividualInternationalLeadMeta-AnalysisMonitorNational Institute of Neurological Disorders and StrokeOutcome StudyPartial EpilepsiesPatientsPharmaceutical PreparationsPharmacologic SubstancePhasePlacebo ControlPlacebo EffectPlacebosPlayRandomizedRandomized Clinical TrialsRandomized Controlled TrialsRefractoryResearchResearch DesignResearch InfrastructureRoleSample SizeSeizuresSiteTarget PopulationsTimebasedemographicsdesigndisease characteristicdosagedrug abusereffective therapyinterestpatient populationpublic health relevanceresponsesuccesstreatment centertreatment effecttrendwillingness
项目摘要
DESCRIPTION (provided by applicant): Clinical trials constitute the gold standard of research that informs treatment of epilepsy as well as the drug approval process. Improper trial design or a design based on incorrect assumptions could lead to the wrong conclusions and, potentially, to a misuse of the drug. The context in which adjunctive-therapy AED trials are designed and conducted has profoundly changed over the past 20 years. Associated with these changes is an observed increased variability in the responder rate both across and within studies and, in particular, an observed increased response to placebo with peaks as high as 40%. Recent analysis of randomized controlled trials of adjunctive AEDs showed that response to placebo has increased significantly over time. Higher than hypothesized placebo response rates can confound the true treatment effect size potentially resulting in failure of investigational AEDs to
show efficacy. The goal of this project is to determine factors associated with response in patients randomized to placebo in adjunctive randomized clinical trials of AEDs in adults and children with focal epilepsy. In collaboration with the NINDS, the International League against Epilepsy has reached an agreement with a number of pharmaceutical companies who have expressed interest in this project and willingness to share information about their trials. Previou meta-analysis have suggested that multiple factors may be responsible for the increasing placebo response rates. These factors contribute at different levels. We will be exploring three major categories of variables. In Aim 1 we will be looking at patient-related factors, in Aim 2 we will focus on trial-specific factors and in Aim 3 we will be looking at site- related factors. The
context in which clinical trials in epilepsy are conducted has changed over time. In order to design the most efficient and most successful trials it is essential to understand what factors need to be taken into consideration during the design phase and the conduct of the trial. The proposed study will help understand these factors and will inform the design of new studies in patients with drug resistant epilepsy.
描述(由申请人提供):临床试验构成研究的黄金标准,为癫痫治疗以及药物审批流程提供信息。不正确的试验设计或基于错误假设的设计可能会导致错误的结论,并可能导致药物的滥用。过去 20 年来,辅助治疗 AED 试验的设计和实施背景发生了深刻的变化。与这些变化相关的是研究之间和研究内部的反应者率变异性增加,特别是观察到对安慰剂的反应增加,峰值高达 40%。最近对辅助 AED 随机对照试验的分析表明,随着时间的推移,对安慰剂的反应显着增加。高于假设的安慰剂反应率可能会混淆真实的治疗效果大小,可能导致研究性 AED 失败
显示功效。 该项目的目标是确定与成人和儿童局灶性癫痫 AED 辅助随机临床试验中随机接受安慰剂的患者反应相关的因素。国际抗癫痫联盟与 NINDS 合作,与多家制药公司达成协议,这些公司表示对此项目感兴趣,并愿意分享其试验信息。之前的荟萃分析表明,多种因素可能导致安慰剂反应率增加。这些因素在不同层面上发挥着作用。我们将探索三大类变量。在目标 1 中,我们将关注与患者相关的因素,在目标 2 中,我们将关注试验特定因素,在目标 3 中,我们将关注与地点相关的因素。 这
随着时间的推移,进行癫痫临床试验的背景已经发生了变化。为了设计最有效和最成功的试验,必须了解在设计阶段和试验进行期间需要考虑哪些因素。拟议的研究将有助于了解这些因素,并为耐药性癫痫患者的新研究设计提供信息。
项目成果
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Emilia Bagiella其他文献
Emilia Bagiella的其他文献
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