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Clinical Trials Regulation

Fighting for regulation that supports innovation in patient care

Well conducted randomised clinical trials are the bedrock of safe and effective, evidence-based treatment of cardiovascular disease. However, the cost and complexity of clinical trials has risen out of all proportion. The ESC alongside other leading research organisations, is fighting to improve complex and ineffective clinical trial 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

 

Further information

For more information read the ESC papers: