Department of Oncology, University Clinic of Navarra and Health Research Institute of Navarra (IdiSNA), Pamplona, Spain.
Centre Oscar Lambret and Lille University, Lille, France.
Ann Oncol. 2023 Jan;34(1):70-77. doi: 10.1016/j.annonc.2022.09.162. Epub 2022 Oct 7.
During recent years, the burden of bureaucracy in clinical research has increased dramatically, adversely impacting the activity of investigators and clinical research teams. Although compliance with the Declaration of Helsinki, the guidelines for Good Clinical Practice (GCP), and other applicable regulations remains unquestionable, their overinterpretation and substitution by the internal operating procedures of sponsors and Contract Research Organizations (CROs) have increased the administrative burden. A survey conducted by the European Society for Medical Oncology (ESMO) Clinical Research Observatory (ECRO) among 940 investigators confirmed that they considered that the administrative burden in clinical research is excessive; that administrative procedures could be reduced without affecting the safety and the rights of the patients and the quality of the data; and that bureaucracy represents an obstacle for clinical research.
A panel of physicians with extensive experience in clinical research, composed by members of the ECRO and the ESMO Scientific Medical and Public Policy divisions, analyzed clinical trial procedures related to administrative workflow, pharmacovigilance, and medical care.
The panel identified situations that generate debate between investigators and sponsors/CROs and selected real clinical scenarios that exemplify such situations. The panel discussed and proposed specific recommendations for those situations, based on GCP.
This initiative aspires to streamline clinical research procedures and to become a platform for discussion among all clinical trial stakeholders, with the aim of promoting the sustainability of clinical research and the care of cancer patients.
近年来，临床研究中的官僚负担急剧增加，对研究者和临床研究团队的活动产生了不利影响。尽管遵守赫尔辛基宣言、良好临床实践指南（GCP）和其他适用法规是毫无疑问的，但对其过度解释以及赞助商和合同研究组织（CRO）内部操作程序的替代增加了行政负担。欧洲肿瘤内科学会（ESMO）临床研究观察站（ECRO）对 940 名研究者进行的调查证实，他们认为临床研究中的行政负担过重；在不影响患者安全和权利以及数据质量的情况下，可以减少行政程序；官僚主义是临床研究的障碍。
一个由 ECRO 和 ESMO 科学医学和公共政策部门成员组成的、在临床研究方面拥有丰富经验的医师小组，分析了与行政工作流程、药物警戒和医疗相关的临床试验程序。
该小组确定了在研究者和赞助商/CRO 之间引发争议的情况，并选择了体现这些情况的真实临床场景。该小组根据 GCP 讨论并提出了这些情况的具体建议。
这一举措旨在简化临床研究程序，并成为所有临床试验利益相关者讨论的平台，旨在促进临床研究的可持续性和癌症患者的护理。
