RESUMEN
Sharing metadata, individual participant data and summary data, as a complement to results dissemination and trial registration requirements, is perceived to be advantageous by enabling faster and more accurate meta-analyses and reducing the need for additional trials. To date, various models of data access have been utilized in order to manage clinical trials data sharing and access in line with the rights and interests of sponsors, researchers and patients involved in clinical trials. In order to ensure responsible data sharing, the data access review process should be developed in a way that ensures fairness, transparency and objectivity. In this article, we critically review some examples of current governance models in clinical trials data sharing and suggest approaches to ensure the objectivity of the data access review process.
Asunto(s)
Ensayos Clínicos como Asunto , Difusión de la Información/métodos , Industria Farmacéutica/organización & administración , Humanos , Universidades/organización & administraciónRESUMEN
The World Anti-Doping Agency (WADA) sets out a detailed description of what its own conception of the "spirit of sport" as employed in the World Anti-Doping Code (WADC) entails. However, controversies as to the significance and meaning to be ascribed to the term abound in the literature. In order to unravel the core of the debates and to move discussions forward, the authors aimed at reviewing understandings of the spirit of sport in the conceptual literature. The main databases were searched using relevant keywords. After the inclusion and exclusion criteria were applied, eighteen publications were included in the review. The most striking result to emerge from the data is the multivalence of the concept of spirit of sport. Our thematic analysis generated the contestability of the spirit of sport as the predominant theme in the conceptual literature. There is a need for empirical research to generate data about perspectives on the spirit of sport from other stakeholders especially those of the athletes themselves.