Clinical trial data sharing in the 21st century: a scoping review of the literature, IMPACT Observatory

<p><b>Presented: 8th Croatian Cochrane Symposium, Split, Croatia, May 2016</b></p><p>The overall goal of the IMPACT Observatory is assessing ongoing transitions of clinical trial research regarding data sharing due to the increasing understanding of the importance of reanalysis of raw data for advancement of science, reducing research waste, and increasing the reliability of evidence gained by systematic reviews of clinical trials (CTs). </p> <p>This poster presents the preliminary results of a scoping review of literature aiming to assess the dynamics of clinical trial data transparency and related changes of culture, policies and practice since the baseline set in year 2000. </p> <p>In the analysis of 132 selected papers the changes in CT data sharing since 2000 were mapped. The focus of the scientific community evolved from publication bias over protocol disclosure to sharing of aggregate and raw data and forming databases and registries with open access. Players include journal editors, publishers, researchers, funders, pharmaceutical industry, media, consumers, and regulators. </p> <p>Data sharing, culture, guidelines, standards, policies, and databases are the main topics discussed. The lack of methods and standards of data sharing are identified as the main gaps.</p>