The Parc Taulí Research and Innovation Institute (I3PT)-CERCA has participated in the clinical research training of surgeons in Spain through the publication of four methodological letters a Spanish Surgery, the reference journal for Spanish and Latin American surgeons.
The preparation of these documents, under the leadership of Dr. Xavier Serra Aracil, coordinator of the Surgery and Interventional Procedures research area of the I3PT, aims provide specific guidance on methodological aspects of clinical research. The work has had the close collaboration of different professionals from the Institute such as Marc Fradera and Raúl Muñoz, from the Research Support Unit, Guillem Cebrián, responsible for Scientific Production and Open Science, and the doctor in training Anna Nonell, from the General Surgery and Digestive System service at the Parc Taulí University Hospital.
Each of the letters addresses a specific topic related to design, transparency, and data analysis in clinical studies, and provides practical tools and insights for the surgical community:
(authors: Xavier Serra Aracil and Anna Nonell)
This letter emphasizes the importance of registering clinical trials in public and accessible databases such as ClinicalTrials.gov and EudraCT. The aim is to ensure the transparency and integrity of clinical studies, following international standards to foster public trust and the responsibility of researchers and investigators.
(authors: Xavier Serra Aracil and Marc Fradera)
The SAP is an essential document to ensure the transparency and reproducibility of statistical analyses. This letter offers a practical guide to preparing it, detailing the key elements it should contain, such as methodology, missing data management and statistical justification. It also emphasizes the need for collaboration between researchers and statisticians to ensure optimal planning.
(authors: Guillem Cebrián and Raul Muñoz)
In the framework of open science, this letter explains how to deposit study data in open access repositories to promote transparency, collaboration and access to scientific knowledge. The steps necessary to prepare and deposit the data are described, ensuring that they comply with legal and ethical requirements and that they are locatable, accessible, interoperable and reusable by other researchers.
(authors: Xavier Serra Aracil and Marc Fradera)
This letter addresses the specific characteristics of non-inferiority clinical trials used to compare new treatments with existing treatments to ensure they are not clinically inferior within an acceptable margin. Aspects such as the definition of the non-inferiority margin, the calculation of the sample size and the appropriate interpretation of the results are highlighted.
This initiative of the I3PT not only strengthens its own commitment to excellence in clinical research, but also contributes to the continuous training of the research community, offering methodological tools that improve the quality and transparency of their studies.
Along these lines, Serra has also directed and published through the Spanish Association of Surgeons (AEC) the Manual How to train and motivate the surgery resident? Training program for resident tutors, a resource focused on guiding all tutors in charge of instructing General Surgery and Digestive System residents, and How and why research in surgery, the first manual in the State that is aimed at surgeons and that specifically addresses research in this area.
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