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Abstract：
BACKGROUND: Statisticians are fundamental in ensuring clinical research, including clinical trials, are conducted with quality, transparency, reproducibility and integrity. Good Clinical Practice (GCP) is an international quality standard for the conduct of clinical trials research. Statisticians are required to undertake training on GCP but existing training is generic and, crucially, does not cover statistical activities. This results in statisticians undertaking training mostly unrelated to their role and variation in awareness and implementation of relevant regulatory requirements with regards to statistical conduct. The need for role-relevant training is recognised by the UK NHS Health Research Authority and the Medicines and Healthcare products Regulatory Agency (MHRA).
METHODS: The Good Statistical Practice (GCP for Statisticians) project was instigated by the UK Clinical Research Collaboration (UKCRC) Registered Clinical Trials Unit (CTU) Statisticians Operational Group and funded by the National Institute for Health and Care Research (NIHR), to develop materials to enable role-specific GCP training tailored to statisticians. Review of current GCP training was undertaken by survey. Development of training materials were based on MHRA GCP. Critical review and piloting was conducted with UKCRC CTU and NIHR researchers with comment from MHRA. Final review was conducted through the UKCRC CTU Statistics group.
RESULTS: The survey confirmed the need and desire for the development of dedicated GCP training for statisticians. An accessible, comprehensive, piloted training package was developed tailored to statisticians working in clinical research, particularly the clinical trials arena. The training materials cover legislation and guidance for best practice across all clinical trial processes with statistical involvement, including exercises and real-life scenarios to bridge the gap between theory and practice. Comprehensive feedback was incorporated. The training materials are freely available for national and international adoption.
CONCLUSIONS: All research staff should have training in GCP yet the training undertaken by most academic statisticians does not cover activities related to their role. The Good Statistical Practice (GCP for Statisticians) project has developed and extensively piloted new, role-specific, comprehensive, accessible GCP training tailored to statisticians working in clinical research, particularly the clinical trials arena. This role-specific training will encourage best practice, leading to transparent and reproducible statistical activity, as required by regulatory authorities and funders.
METHODS: The Good Statistical Practice (GCP for Statisticians) project was instigated by the UK Clinical Research Collaboration (UKCRC) Registered Clinical Trials Unit (CTU) Statisticians Operational Group and funded by the National Institute for Health and Care Research (NIHR), to develop materials to enable role-specific GCP training tailored to statisticians. Review of current GCP training was undertaken by survey. Development of training materials were based on MHRA GCP. Critical review and piloting was conducted with UKCRC CTU and NIHR researchers with comment from MHRA. Final review was conducted through the UKCRC CTU Statistics group.
RESULTS: The survey confirmed the need and desire for the development of dedicated GCP training for statisticians. An accessible, comprehensive, piloted training package was developed tailored to statisticians working in clinical research, particularly the clinical trials arena. The training materials cover legislation and guidance for best practice across all clinical trial processes with statistical involvement, including exercises and real-life scenarios to bridge the gap between theory and practice. Comprehensive feedback was incorporated. The training materials are freely available for national and international adoption.
CONCLUSIONS: All research staff should have training in GCP yet the training undertaken by most academic statisticians does not cover activities related to their role. The Good Statistical Practice (GCP for Statisticians) project has developed and extensively piloted new, role-specific, comprehensive, accessible GCP training tailored to statisticians working in clinical research, particularly the clinical trials arena. This role-specific training will encourage best practice, leading to transparent and reproducible statistical activity, as required by regulatory authorities and funders.
摘要：
背景：统计学家是确保临床研究的基础，包括临床试验,是以质量进行的，透明度，再现性和完整性。良好临床实践规范（GCP）是进行临床试验研究的国际质量标准。统计师需要进行GCP培训，但现有培训是通用的，至关重要的是,不包括统计活动。这导致统计人员接受培训，大多与他们在认识和执行有关统计行为的相关监管要求方面的作用和变化无关。需要与角色相关的培训是由英国NHS健康研究管理局和药品和保健产品监管机构（MHRA）认可的。
方法：良好统计规范（统计学家GCP）项目由英国临床研究合作组织（UKCRC）注册临床试验单位（CTU）统计学家运营小组发起，并由美国国家卫生和护理研究所资助研究（NIHR），开发材料，以便为统计人员量身定制特定角色的GCP培训。通过调查对当前的GCP培训进行了审查。培训材料的开发基于MHRAGCP。与UKCRCCTU和NIHR研究人员一起进行了严格的审查和试点，并发表了MHRA的评论。最后审查是通过UKCRCCTU统计小组进行的。
结果：调查证实了为统计人员开发专门的GCP培训的需要和愿望。一个可访问的，全面,试点培训包是为从事临床研究的统计学家量身定制的，尤其是临床试验领域。培训材料涵盖统计学参与的所有临床试验过程中的最佳实践的立法和指导。包括练习和现实生活场景，以弥合理论与实践之间的差距。综合反馈。培训材料可免费提供，供国家和国际采用。
结论：所有研究人员都应接受GCP培训，但大多数学术统计人员进行的培训不包括与其角色相关的活动。良好统计规范（统计员GCP）项目已制定并广泛试行了新的，特定于角色，全面,为从事临床研究的统计学家量身定制的GCP培训，尤其是临床试验领域。这种特定角色的培训将鼓励最佳实践，导致透明和可重复的统计活动，根据监管机构和出资人的要求。
方法：良好统计规范（统计学家GCP）项目由英国临床研究合作组织（UKCRC）注册临床试验单位（CTU）统计学家运营小组发起，并由美国国家卫生和护理研究所资助研究（NIHR），开发材料，以便为统计人员量身定制特定角色的GCP培训。通过调查对当前的GCP培训进行了审查。培训材料的开发基于MHRAGCP。与UKCRCCTU和NIHR研究人员一起进行了严格的审查和试点，并发表了MHRA的评论。最后审查是通过UKCRCCTU统计小组进行的。
结果：调查证实了为统计人员开发专门的GCP培训的需要和愿望。一个可访问的，全面,试点培训包是为从事临床研究的统计学家量身定制的，尤其是临床试验领域。培训材料涵盖统计学参与的所有临床试验过程中的最佳实践的立法和指导。包括练习和现实生活场景，以弥合理论与实践之间的差距。综合反馈。培训材料可免费提供，供国家和国际采用。
结论：所有研究人员都应接受GCP培训，但大多数学术统计人员进行的培训不包括与其角色相关的活动。良好统计规范（统计员GCP）项目已制定并广泛试行了新的，特定于角色，全面,为从事临床研究的统计学家量身定制的GCP培训，尤其是临床试验领域。这种特定角色的培训将鼓励最佳实践，导致透明和可重复的统计活动，根据监管机构和出资人的要求。
