Press release

HRA and MHRA welcome public consultation on application of transparency rules of EU Clinical Trial Regulation

Health Research Authority (HRA) and Medicines and Healthcare products Regulatory Agency (MHRA) welcome public consultation.

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) today 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 authorisation, 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.

You can see the consultation on the EMA website.

HRA and MHRA encourage all interested parties to respond directly to the EMA proposals.

HRA is a signatory to the Alltrials campaign, which advocates that clinical research should adopt principles of open research. More information about Alltrials is on their website.

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Background: HRA

  1. HRA’s goal is to make the UK a global leader for health research.
  2. The primary role is to protect and promote the interests of patients and the public in health research and to streamline the regulation of research. We are committed to promoting transparency and patient and public involvement in health research.
  3. HRA approval is an improvement programme that will see a single approval process being implemented across the NHS.
  4. HRA approval will also provide the platform for delivering the EU clinical trials regulations, ensuring the UK is ready and prepared and Industry can place studies in the UK with continued confidence in UK readiness.

About transparency in research

  1. HRA enables good quality ethical research. It is incumbent on researchers, sponsors and funders to further the wider knowledge in their area of study, through the publication and dissemination of research findings, publishing all results, making data accessible to others and registering clinical trials.
  2. In July 2013, HRA published a plan of action to improve transparency in health research. The full transparent research report is available on the HRA website.
  3. See information on transparency also.

Background: MHRA

MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are as safe as is reasonably possible. Underpinning all our work lies strong and evidence-based judgements to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare Products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research.

About the new EU Clinical Trials Regulation

The EU Clinical Trials Regulation No 536/2014 will replace the existing EU Clinical Trials Directive and will streamline the authorisation process and harmonise requirements for clinical trials in Europe making it easier to conduct clinical research in the EU. It also increases the transparency on clinical trial data by ensuring that all trials are registered, the information on clinical trials is publicly available, summaries of all trials are published within a year after a trial has ended and clinical study reports submitted in support of marketing authorisation applications will have to be published within a month after a regulatory decision on the application.

It will apply from May 2016 unless the IT infrastructure that underpins the regulation is not fully functional.

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