Avrupa Kardiyoloji Derneği, AB Klinik Çalışmalar Direktifinin revizyonunu olumlu karşıladı (İng)



ESC Welcomes EU Clinical trials directive revisions

A position paper by the European Society of Cardiology (ESC) welcomes the European Commission’s proposed revision of the text of the European Clinical Trials Directive as an important contribution to “simplifying, clarifying and streamlining” rules for conducting clinical trials across Europe. 

The ESC’s main recommendations  include  the suggestion for the role of Reporting Member States to be extended to cover “aspects of an intrinsic ethical or national/local nature”,Greater representation of women, different age groups and ethnic minorities in trials, the ESC stress, would further enhance the cardiovascular (CV) research environment across Europe. The ESC stresses that the development of pharmaceutical products and the improvement of medical treatment strongly rely on innovative clinical research – of which clinical trials are an essential component – in order to tackle effectively societal challenges in health. ESC feels that there is a clear need to facilitate academically driven, well organised clinical research projects in Europe, while maintaining the necessary regulations to ensure that these possibilities are used in the best interest of the citizens (and potential patients) of Europe.  

One of the main obstacles to medical research generated by the 2001 Clinical Trials Directive is related to the obligation of a unique sponsor, bearing the legal responsibilities of the trial. While such a system may be well suited for industry-led clinical research, it proved detrimental to investigator-led research or research initiated in academic institutions because it places an obligation for onerous administration, pharmacovigilance, adverse event reporting, archiving, good clinical practice, drug packaging, site visits, etc. Many organisations of the non-commercial sector are unprepared to accept this role. The current directive also does not allow joining third country-led trials, keeping European centres away from possible projects led, in particular, by the United States. 

The ESC also feels that The overall impact of the 2001/20/EC Directive goes against the EU 2020 strategy, by reducing Europe’s competitiveness and attractiveness when it comes to medical clinical research. Europe is now lagging behind the US in terms of research, scientific publication and consequently attractiveness to young researchers.

The position paper overall welcomes the proposed changes  specifically: 

  1. The creation of a single EU portal to submit applications. Such solution will simplify the administrative work of academic researchers and investigator led research project, notably for large-scale multi-national trials;
  2. The creation of a dedicated database administered by the European Commission, which will contain the data and information submitted through the EU portal. However, the ESC recommends that all EU databases related to clinical trials (EUdraCT, EU Clinical Trials Register) and pharmacovigilance (EudraVigilance) are designed as to avoid any unnecessary duplication for the regulators, the users and the targeted public;
  3. The creation of a European database to report all adverse events experienced during clinical trials;
  4. The definition of “investigational medicinal products” and of “auxiliary medicinal products” contained in Chapter IX of the proposal;
  5. The revision of the “sponsor” concept and  the newly introduced concept of “co-sponsorship” which will alleviate the tasks and responsibilities that previously had to be supported by the investigator-led and academic researchers, by allowing some of these tasks to be shared among co-sponsors;
  6. The possibility to have, for the first time, sponsors of clinical trials located in third countries which will allow European researchers to work with the best teams of researchers, outside the European Union;
  7. The new proposal will take the form of a regulation to replace the existing directive.  This legal form will ensure a higher level of harmonization and consistency across Member States;


The ESC further made following recommendations: 

  1. Enrol a significant proportion of women, young and elderly subjects as well as individuals of different ethnic origins;
  2. Acknowledge the need for methodological, technological and operational support for the involvement of imaging techniques;

Setting up of an appropriate consultation structure at EU level for the purpose the design of simpler non-registration trials.