The Valdecilla Clinical Trials Unit and the Research Support Unit of the Marqués de Valdecilla Research Institute (IDIVAL) have highlighted the importance of specialised talent in supporting the execution of clinical trials. This announcement comes in light of recent findings published in a comprehensive review on challenges and solutions in the field of clinical trials.
The study, entitled ‘Navigating the challenges of clinical trial professionals in the healthcare sector’ and published in Frontiers in Medicine, reveals that the complexity and evolving nature of clinical trials requires specialised and ongoing training for the professionals involved. These professionals include principal investigators, clinical research coordinators (CRCs), nurses, clinical trial pharmacists and monitors, each facing unique challenges such as maintaining protocol compliance, managing investigational products and ensuring data integrity.
The publication emphasises that addressing these challenges requires clear role delineation, continuous professional development and supportive work environments to improve staff retention and trial outcomes. Enhanced training programmes and a collaborative approach are essential for the successful conduct of clinical trials and the advancement of medical research.
Blanca Sánchez-Santiago, co-author of the study and member of the Clinical Pharmacology Service of the Clinical Trials Unit at the Marqués de Valdecilla University Hospital, added: ‘It is crucial to invest in competence development and clear role definition within clinical trial teams to ensure data integrity and participant well-being’.
The article also highlights the need for adequate support systems that are characterised by a highly demanding organisational framework, based on the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. This guideline sets the international standard for ethical and scientific quality in the design, conduct and reporting of clinical trials, protecting the rights, safety and well-being of trial participants.
The Valdecilla Clinical Trials Unit and the IDIVAL Research Support Unit continue to lead efforts to improve training and support for clinical trial professionals, recognising that talent and training are fundamental to the success and quality of clinical research.
Reference:
