New central support for registration and reporting of clinical research
Starting from the beginning of 2021, registration and reporting of clinical research in international clinical trial registries has been centralized at KI. The Compliance & Data Office (CDO) is responsible for the implementation of this newly formed research support initiative and has developed clear information, routines, and web support for KI researchers. The purpose is to ensure transparency and compliance with the regulations and requirements for registration and reporting results.
Clinical trial transparency is defined as the sharing and use of clinical data across global registries. Greater clinical trial transparency leads to improved patient and medical care, advances scientific innovation, and produces overall better healthcare systems. There are also national and international regulations that require clinical research to be registered and results reported in an international clinical trial registry, e.g., clinicaltrials.gov and EudraCT.
At present, however, a majority of European universities fail to update study registrations and report their results in clinical trial registries, and the problem continues to grow. Within the framework of the EU's investment in open science, EU universities and institutions are collaborating to increase transparency and accessibility of clinical data.
“As a university, we are committed to improving transparency and accessibility of the clinical research conducted at KI. An important step in the process is centralizing the registration and reporting process for clinical trials and clinical studies conducted at KI. We have developed specific routines and procedures to support researchers in registering and reporting results that comply with required regulations,” says Tony Durkee, coordinator at CDO.
To make it easier for researchers, CDO has also developed a website that clearly describes the process and procedures for registration and results reporting in clinical trial registries. CDO also offers hands-on support through a one-hour online session assisting with registrations and reporting results.
At CDO, the mission is to provide comprehensive support to KI researchers. In addition to the newly formed support in clinical research, CDO also offers support in research documentation, data management, ethical requirements by external funders, and other issues relevant to the research process. With the new and ongoing support initiatives at CDO, researchers can benefit in advancing their research and enhance transparency and accessibility on the national and international levels.