Quality assurance (QA) in surgical trials is highly complex because of the high variability of surgical expertise, techniques, and the lack of standardized measures to evaluate outcomes. To address these issues, EORTC has launched the SURCARE initiative, which aims to establish an integrated approach to ensuring high QA standards in surgical clinical research in Europe and globally.
A first step in achieving this was to review how elements of quality are described in protocols and case report forms (CRFs) and reported in publications. This systematic review, published in the European Journal of Surgical Oncology, looked at the most common surgical quality parameters and how consistently they were described in study documents from trials led by EORTC from 1980-2013. The authors also analyzed the impact of important changes in the overall landscape of research to the evolution of QA strategies within EORTC.
As an outcome of this review, important strategies such as development of a standard surgical protocol template and establishment of surgical QA processes that includes credentialing, standardization and central monitoring have been initiated.
“The role of a multidisciplinary decision-making process and high quality surgery remains critical to the fight against cancer,” said Laurence Colette, head of statistics at EORTC. “Thus, there is a need to transform surgical studies from a “comic opera” to a major force in cancer research.”
The SURCARE initiative complements existing EORTC QA programs in radiotherapy, imaging and translational research. It provides a platform to develop prospective surgical oncology research through a global network of dedicated researchers and aims to facilitate training of a new generation of surgeons oriented to the culture of clinical research. As part of EORTC’s ongoing quest to improve the management of cancer and patient quality of life, SURCARE aims to help improve surgical care through high quality research.
“Considering the millions of cancer patients who need surgery, better surgical research maybe the most relevant and urgent action we need to prioritize to deliver cost-effective treatment for our patients today,” said Dr. Carmela Caballero, Clinical Research Physician for Surgery, EORTC.