Transparency of information in ongoing and completed clinical trials is an established expectation of society reinforced by regulation and by codes of practice in many parts of the world. It is a necessary pillar to ensure public trust in the clinical trial process and the evaluation of clinical trial outcomes. Discussion is now focused on the different mechanisms for transparency, their scope, objectives and audience. This increased transparency changes the landscape of availability and use of information from clinical trials, and brings with it new opportunities and challenges.
The EU Clinical Trials Register (EU CTR) was launched in March 2011 and as of March 2012 provides information on more than 16,500 clinical trials. During 2012 and 2013, EudraCT and EU CTR will be extended to include summaries of clinical trial results.
EU CTR joins ClinicalTrials.gov and an increasing number of clinical trials registries from different countries and regions covering varying types of trials, which ushers in new challenges and complexities for clinical trial sponsors. Among these challenges is the need for standardisation of the core clinical trial data so that the same trial is correctly represented in the same way in different registries.
Increased numbers of national and industry sponsored registries leave many sponsors pondering strategy, developing operational measures, and looking for efficient ways to manage dissemination of clinical trial protocol information and results data. In spite of considerable sponsor effort and investment, dissatisfaction with the degree of transparency and compliance with existing rules with media, politicians and other stakeholders is still high. Although the original purpose of facilitating the patients’ access to clinical trials has had limited success, other stakeholders including patients find the registries and results databases useful and necessary. Publicly available results databases ensure non-selective data sharing and may reduce the risk that important trial results go undisclosed.