Sonstein Stephen A, Samuels Elias, Aldinger Carmen, White Sarah A, Bierer Barbara E
Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard, 14 Story Street, 4th Floor, Cambridge, MA, 02138, USA.
Michigan Institute for Clinical and Health Research, University of Michigan, Ann Arbor, MI, USA.
Ther Innov Regul Sci. 2022 Jul;56(4):607-615. doi: 10.1007/s43441-022-00395-z. Epub 2022 Mar 31.
The Joint Task Force for Clinical Trial Competency (JTF) conducted a global survey of clinical research professionals requesting respondents to self-assess their competencies in each of the eight domains of its Core Competency Framework version 3.1. The results were analyzed based upon role, years of experience, educational level, professional certification, institutional affiliation, and continuing education participation. Respondents with professional certification self-assessed their competencies in all domains at higher levels than those without professional certification. The survey demonstrated that irrespective of role, experience, or educational level, training curricula in both pre-professional and continuing professional education should include additional content relating to research methods, protocol design, medical product development and regulation, and data management and informatics. These results validate and extend the recommendations of a similar 2016 JTF and other surveys. We further recommend that clinical and translational research organizations and clinical sites assess training needs locally, using both subjective and objective measures of skill and knowledge.
临床试验能力联合特遣部队(JTF)对临床研究专业人员进行了一项全球调查,要求受访者对其在核心能力框架3.1版的八个领域中的每一个领域的能力进行自我评估。根据角色、工作年限、教育水平、专业认证、机构隶属关系和继续教育参与情况对结果进行了分析。拥有专业认证的受访者在所有领域的自我评估能力均高于没有专业认证的受访者。该调查表明,无论角色、经验或教育水平如何,专业前教育和持续专业教育的培训课程都应包括与研究方法、方案设计、医疗产品开发与监管以及数据管理和信息学相关的额外内容。这些结果验证并扩展了2016年JTF类似调查和其他调查的建议。我们进一步建议临床和转化研究组织以及临床机构使用技能和知识的主观和客观衡量标准,在当地评估培训需求。