Clinical Trials Regulation

The challenges

Well-conducted randomised clinical trials are the bedrock of safe and effective, evidence-based treatment of CVD. However, the cost and complexity of clinical trials in CVD have risen out of proportion. This means that many potential new treatments are abandoned before their efficacy has been thoroughly assessed.

While the new EU Clinical Trials Regulation, which is due to enter into application soon, will bring some positive changes, its and EMA’s reliance on the application of international good clinical practice (GCP) standards for the design and conduct of clinical trials is of concern. These standards, determined by the International Council for Harmonisation (ICH), are too complex and fail to produce the intended benefit for patients.

New guidelines are urgently needed for trials where the current guidelines are not fit for purpose. The new guidelines should be:

• based on scientific evidence
• straightforward and simple
• adaptable to individual studies
• suitable and relevant for the multiple settings and contexts where trials are run

The solutions

The ESC has long been advocating for a radical revision of the ICH GCP standards, working collaboratively with the Wellcome Trust, the More Trials campaign and other organisations. Our objectives are:

• to develop new alternative clinical practice guidelines for trials of health
• to advocate for policymakers, regulators, international standards bodies and other funders to implement the new guidelines
• to support researchers to use them in practice

Coalition for Reducing Bureaucracy in Clinical Trials

The ESC takes part in the “Coalition for Reducing Bureaucracy in Clinical Trials”, which reunites medical associations and patient advocates in order to call on regulators, policymakers, sponsors and ethics committees to agree on a substantial reduction of bureaucratic obstacles in clinical trials.

The Coalition issued a statement calling for urgent action to make clinical trials less bureaucratic, more patient-centric and efficient. They also developed a series of concrete and consensus-based recommendations clustered around four main themes: safety reporting, informed consent, regulatory guidelines, and harmonisation of requirements across the EU.

Further information

For more information read the ESC papers:

• Improving public health by improving clinical trial guidelines and their application - European Heart Journal 08 March 2017
• 'Clincial Trial Rules' - European Heart Journal - CardioPulse 14 August 2017