Peralta Galo, Sánchez-Santiago Blanca
Central Support Unit, Instituto de Investigación Marqués de Valdecilla (IDIVAL), Santander, Spain.
Clinical Pharmacology Service, Clinical Trials Unit, Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Marqués de Valdecilla (IDIVAL), Santander, Spain.
Front Med (Lausanne). 2024 Jun 3;11:1400585. doi: 10.3389/fmed.2024.1400585. eCollection 2024.
Clinical trials (CTs) are essential for medical advancements but face significant challenges, particularly in professional training and role clarity. Principal investigators, clinical research coordinators (CRCs), nurses, clinical trial pharmacists, and monitors are key players. Each faces unique challenges, such as maintaining protocol compliance, managing investigational products, and ensuring data integrity. Clinical trials' complexity and evolving nature demand specialized and ongoing training for these professionals. Addressing these challenges requires clear role delineation, continuous professional development, and supportive workplace environments to improve retention and trial outcomes. Enhanced training programs and a collaborative approach are essential for the successful conduct of clinical trials and the advancement of medical research.
临床试验对于医学进步至关重要,但面临重大挑战,尤其是在专业培训和角色清晰度方面。主要研究者、临床研究协调员(CRC)、护士、临床试验药剂师和监查员是关键角色。每个人都面临独特的挑战,例如维持方案依从性、管理研究产品以及确保数据完整性。临床试验的复杂性和不断演变的性质要求为这些专业人员提供专门的持续培训。应对这些挑战需要明确的角色划分、持续的专业发展以及支持性的工作场所环境,以提高人员留存率和试验结果。强化培训计划和协作方法对于临床试验的成功开展和医学研究的进步至关重要。