PDF(Pubmed)
Abstract：
UNASSIGNED: While clinical trials provide high-quality evidence guiding medical decision-making, early trial termination can result in both lost time and resources. Our purpose was to investigate the rate of and reasons for clinical trial termination for hand and wrist-related conditions and identify study characteristics associated with early trial termination.
UNASSIGNED: The ClinicalTrials.gov database was queried for all hand and wrist-related clinical trials. All terminated and completed trials were reviewed, with characteristics and reasons for termination recorded. Study characteristics included type, purpose, intervention assessed, enrollment, group allocation, blinding, trial phase, sponsor type, and geographic region. Chi-square test was used to identify associations between trial characteristics and terminated versus completed status.
UNASSIGNED: A total of 793 hand and wrist-related clinical trials were identified, with 77 trials (10%) terminated prior to completion. The most common reason for termination was \"recruitment/retention difficulty,\" reported in 37 (48%) terminated trials. In comparing competed versus terminated trials, primary purpose (nonobservational studies), enrollment (<50 patients), and geographic region (North America) were all significantly more likely to be terminated. Terminated trials were more likely to have an intervention type investigating a specific device or drug.
UNASSIGNED: Early trial termination for hand and wrist-related conditions is common (10%), with patient recruitment and retention identified as the leading cause of termination. Trials involving potential commercial incentives (those investigating a device or drug) were associated with an increased rate of trial termination.
UNASSIGNED: An emphasis on patient enrollment during study design may aid in mitigating the most common cause of early clinical trial termination.
UNASSIGNED: The ClinicalTrials.gov database was queried for all hand and wrist-related clinical trials. All terminated and completed trials were reviewed, with characteristics and reasons for termination recorded. Study characteristics included type, purpose, intervention assessed, enrollment, group allocation, blinding, trial phase, sponsor type, and geographic region. Chi-square test was used to identify associations between trial characteristics and terminated versus completed status.
UNASSIGNED: A total of 793 hand and wrist-related clinical trials were identified, with 77 trials (10%) terminated prior to completion. The most common reason for termination was \"recruitment/retention difficulty,\" reported in 37 (48%) terminated trials. In comparing competed versus terminated trials, primary purpose (nonobservational studies), enrollment (<50 patients), and geographic region (North America) were all significantly more likely to be terminated. Terminated trials were more likely to have an intervention type investigating a specific device or drug.
UNASSIGNED: Early trial termination for hand and wrist-related conditions is common (10%), with patient recruitment and retention identified as the leading cause of termination. Trials involving potential commercial incentives (those investigating a device or drug) were associated with an increased rate of trial termination.
UNASSIGNED: An emphasis on patient enrollment during study design may aid in mitigating the most common cause of early clinical trial termination.
摘要：
虽然临床试验提供了指导医疗决策的高质量证据，提前终止试验可能导致时间和资源的损失.我们的目的是调查手和手腕相关疾病的临床试验终止率和原因，并确定与早期试验终止相关的研究特征。
■在ClinicalTrials.gov数据库中查询了所有与手部和腕部相关的临床试验。对所有终止和完成的试验进行审查，记录终止的特征和原因。研究特征包括类型，目的,干预评估，招生,组分配,盲法,试验阶段,赞助商类型,和地理区域。使用卡方检验来确定试验特征与终止状态和完成状态之间的关联。
■总共确定了793项与手和手腕相关的临床试验，77项试验(10%)在完成前终止。最常见的终止原因是“招聘/保留困难，“在37例（48%）终止试验中报告。在比较竞争和终止试验时，主要目的(非观察性研究)，登记（<50名患者），和地理区域（北美）都更有可能被终止。终止试验更可能有干预类型调查特定的设备或药物。
■手部和腕部相关疾病的早期试验终止是常见的（10％），患者招募和保留被确定为终止合同的主要原因。涉及潜在商业激励的试验（调查设备或药物的试验）与试验终止率的增加有关。
■在研究设计过程中强调患者招募可能有助于减轻早期临床试验终止的最常见原因。
■在ClinicalTrials.gov数据库中查询了所有与手部和腕部相关的临床试验。对所有终止和完成的试验进行审查，记录终止的特征和原因。研究特征包括类型，目的,干预评估，招生,组分配,盲法,试验阶段,赞助商类型,和地理区域。使用卡方检验来确定试验特征与终止状态和完成状态之间的关联。
■总共确定了793项与手和手腕相关的临床试验，77项试验(10%)在完成前终止。最常见的终止原因是“招聘/保留困难，“在37例（48%）终止试验中报告。在比较竞争和终止试验时，主要目的(非观察性研究)，登记（<50名患者），和地理区域（北美）都更有可能被终止。终止试验更可能有干预类型调查特定的设备或药物。
■手部和腕部相关疾病的早期试验终止是常见的（10％），患者招募和保留被确定为终止合同的主要原因。涉及潜在商业激励的试验（调查设备或药物的试验）与试验终止率的增加有关。
■在研究设计过程中强调患者招募可能有助于减轻早期临床试验终止的最常见原因。
