Health Research Authority (HRA) and Medicines and Healthcare products Regulatory Agency (MHRA) welcome the public consultation on how the transparency rules of the European Clinical Trial Regulation will be applied in the new clinical trial database.
The consultation launched by the European Medicines Agency (EMA) is inviting contributions from stakeholders until Wednesday 18 February 2015.
Through the European Clinical Trial Regulation, the level of information publicly available for each clinical trial carried out in the EU will be transformed - requiring transparency on the authorization, conduct and results of trials.
The key instrument for research transparency is the clinical trial database which EMA is responsible for developing in association with the member states. This database will be used for clinical trial applications and will be a source of public information on all clinical trials conducted in the EU. The consultation calls for comment and feedback from the public and all interested parties in connection with the practical application of the transparency rules for the clinical trial portal and database.
Janet Wisely, Chief Executive for HRA said: “Transparency in health research is fundamental to medical advancement, improving efficiencies and increasing public confidence. Through greater transparency we can further enable high quality, ethical health research. HRA welcomes EMA’s consultation on the application of transparency rules within the new clinical trial database. We continue to support this important agenda, and the progress we have made in terms of the registration of all study types leaves the UK well prepared for this legislation. Our simple deferral mechanism for early phase trials with issues of commercial sensitivity provide a model for Europe that creates a balance of transparency, patient safety and competitiveness for attracting these trials. We strongly encourage participation in this important EMA consultation.”
Martyn Ward, head of clinical trials for MHRA said: “It is important that information on clinical trials is made available to the research community, patients and the public but at the same time we must ensure that researchers in Europe are not put at a competitive disadvantage compared to other parts of the world. MHRA is supportive of more transparency on clinical trial data and we welcome the European Medicines Agency’s consultation on how the transparency rules of the European Clinical Trials Regulation will be applied in the new clinical trials database and encourage all stakeholders to respond to it.”