Clinical Trials Registries and Results Databases

Abstract

Trial registration and results disclosure are considered powerful tools for achieving higher levels of transparency and accountability for clinical trials. New emphasis on knowledge sharing and growing demands for transparency in clinical research are contributing to a major paradigm shift in health research that is well underway. In this new paradigm, knowledge will be generated from the culmination of all existing knowledge – not just from parts and bits of previous knowledge, as is largely the case now. The full transparency of clinical research is a powerful strategy to diminish publication bias, increase accountability, avoid unnecessary duplication of research, advance research more efficiently, provide more reliable evidence for diagnostic and therapeutic prescriptions, and regain public trust. Transparency of clinical trials, at a minimum, means sharing information about design, conduct, and results. The information itself must be explicitly documented, but then an access location or medium for distribution must be provided. In the case of clinical trials, the public disclosure of data is realized by posting them in well-defined, freely accessible clinical trial registries and results databases.