Tracking the timely dissemination of clinical studies. Characteristics and impact of 10 tracking variables [version 1; peer review: 2 approved]

Background: Several meta-research studies and benchmarking activities have assessed how comprehensively and timely, academic institutions and private companies publish their clinical studies. These current “clinical trial tracking” activities differ substantially in how they sample relevant studies, and how they follow up on their publication. Methods: To allow informed policy and decision making on future publication assessment and benchmarking of institutions and companies, this paper outlines and discusses 10 variables that influence the tracking of timely publications. Tracking variables were initially selected by experts and by the authors through discussion. To validate the completeness of our set of variables, we conducted i) an explorative review of tracking studies and ii) an explorative tracking of registered clinical trials of three leading German university medical centres. Results: We identified the following 10 relevant variables impacting the tracking of clinical studies: 1) responsibility for clinical studies, 2) type and characteristics of clinical studies, 3) status of clinical studies, 4) source for sampling, 5) timing of registration, 6) determination of completion date, 7) timeliness of dissemination, 8) format of dissemination, 9) source for tracking, and 10) inter-rater reliability. Based on the description of these tracking variables and their influence, we discuss which variables could serve in what ways as a standard assessment of “timely publication”. Conclusions: To facilitate the tracking and consequent benchmarking of how often and how timely academic institutions and private companies publish clinical study results, we have two core recommendations. First, the improvement in the link between registration and publication, for example via institutional policies for academic institutions and private companies. Second, the comprehensive and transparent reporting of tracking studies according to the 10 variables presented in this paper

Assessing the Organizational Climate for Translational Research with a New Survey Tool

Promoting translational research as a means to overcoming chasms in the translation of knowledge through successive fields of research from basic science to public health impacts and back is a central challenge for research managers and policymakers. Organizational leaders need to assess baseline conditions, identify areas needing improvement, and to judge the impact of specific initiatives to sustain or improve translational research practices at their institutions. Currently, there is a lack of such an assessment tool addressing the specific context of translational biomedical research. To close this gap, we have developed a new survey for assessing the organizational climate for translational research. This self-assessment tool measures employees’ perceptions of translational research climate and underlying research practices in organizational environments and builds on the established Survey of Organizational Research Climate, assessing research integrity. Using this tool, we show that scientists at a large university hospital (Charité Berlin) perceive translation as a central and important component of their work. Importantly, local resources and direct support are main contributing factors for the practical implementation of translation into their own research practice. We identify and discuss potential leverage points for an improvement of research climate to foster successful translational research.Peer Reviewe